Pub Date : 2025-04-21DOI: 10.1097/sla.0000000000006737
Christina M Stuart,Yizhou Fei,Kathryn L Colborn,Yaxu Zhuang,William G Henderson,Adam R Dyas,Michael R Bronsert,Robert A Meguid
OBJECTIVETo compare statistical models applied to electronic health record (EHR) data to predict and identify non-infectious postoperative complications. The models have been published and are part of the Automated Surveillance of Postoperative Infections (ASPIN) project, which has expanded to include non-infectious complications.SUMMARY OF BACKGROUND DATAPostoperative complications occur in 15% of nonemergent inpatient surgeries. Most reporting of postoperative complications relies on manual chart abstraction.METHODSPreoperative and postoperative probabilities of non-infectious complications for patients from 5 large hospitals in Colorado were estimated using ASPIN models that were developed using the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) gold standard outcomes. Observed:expected (O:E) ratios were estimated by dividing the sum of the postoperative probabilities by the sum of the preoperative probabilities. O:E ratios were compared between local ACS-NSQIP patients using ACS-NSQIP data, local ACS-NSQIP patients using EHR data, and all patients undergoing operations in the study period using EHR data.RESULTSO:E ratios for 9 non-infectious postoperative complications were estimated. Comparison of the O:E ratios of ACS-NSQIP patients using ACS-NSQIP data vs. EHR data showed overlapping confidence intervals in 44 (98%) of 45 comparisons (5 hospitals x 9 outcomes) and agreement in outlier status for 35 (78%).CONCLUSIONSRisk-adjusted postoperative outcomes estimated using machine learning on EHR data were similar to those produced by manual chart review. These models could be used to augment manual chart review to guide surgical quality improvement.
{"title":"Estimation of Risk-Adjusted Outcomes for Non-Infectious Postoperative Complications using Interpretable Machine Learning and Electronic Health Record Data.","authors":"Christina M Stuart,Yizhou Fei,Kathryn L Colborn,Yaxu Zhuang,William G Henderson,Adam R Dyas,Michael R Bronsert,Robert A Meguid","doi":"10.1097/sla.0000000000006737","DOIUrl":"https://doi.org/10.1097/sla.0000000000006737","url":null,"abstract":"OBJECTIVETo compare statistical models applied to electronic health record (EHR) data to predict and identify non-infectious postoperative complications. The models have been published and are part of the Automated Surveillance of Postoperative Infections (ASPIN) project, which has expanded to include non-infectious complications.SUMMARY OF BACKGROUND DATAPostoperative complications occur in 15% of nonemergent inpatient surgeries. Most reporting of postoperative complications relies on manual chart abstraction.METHODSPreoperative and postoperative probabilities of non-infectious complications for patients from 5 large hospitals in Colorado were estimated using ASPIN models that were developed using the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) gold standard outcomes. Observed:expected (O:E) ratios were estimated by dividing the sum of the postoperative probabilities by the sum of the preoperative probabilities. O:E ratios were compared between local ACS-NSQIP patients using ACS-NSQIP data, local ACS-NSQIP patients using EHR data, and all patients undergoing operations in the study period using EHR data.RESULTSO:E ratios for 9 non-infectious postoperative complications were estimated. Comparison of the O:E ratios of ACS-NSQIP patients using ACS-NSQIP data vs. EHR data showed overlapping confidence intervals in 44 (98%) of 45 comparisons (5 hospitals x 9 outcomes) and agreement in outlier status for 35 (78%).CONCLUSIONSRisk-adjusted postoperative outcomes estimated using machine learning on EHR data were similar to those produced by manual chart review. These models could be used to augment manual chart review to guide surgical quality improvement.","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":"16 1","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143857419","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-21DOI: 10.1097/sla.0000000000006733
Rahul D Kunju,Christi Titus Varghese,Krishnanunni Nair,Shweta Mallick,Binoj Sivasankara Pillai Thankamony Amma,Ramachandran N Menon,Dinesh Balakrishnan,Unnikrishnan Gopalakrishnan,Sudheer Ov,S Sudhindran
OBJECTIVETo assess the safety and efficacy of intermittent inflow occlusion (IIO) during robotic right donor hepatectomy (RDH) for adult living donor liver transplantation.SUMMARY BACKGROUND DATAAlthough evidence supports minimally invasive donor hepatectomy, its adoption by surgeons remains limited. Key challenges include bleeding during parenchymal transection and prolonged warm ischemia during graft extraction, resulting in morbidity in both the donor and recipient.METHODSBetween April 2022 and June 2023, out of 123 donors suitable for RDH, 113 were randomised to undergo robotic RDH with (n=56) or without (n=57) IIO. The primary endpoint was the blood loss during robotic RDH. The secondary end points included peak levels of bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), INR and complications in donors and recipients. Additionally, peak lactate levels and the need for blood transfusion were assessed in donors.RESULTSThe mean duration of IIO was 42.48±11.21 minutes .Blood loss during parenchymal transection (235 (186.25 - 375) vs. 295 (235 - 475),P=0.006) and total blood loss (275 (212.5 - 430) vs. 330 (272.5- 520),P=0.018) were significantly lower among donors in the IIO arm. In recipients belonging to IIO arm, peak ALT (P=0.032) and INR (P=0.012) were significantly low. Although statistically similar, the peak AST (P=0.064) and acute kidney injury (1,P=0.061) in the IIO arm among recipients were also less. Other perioperative outcomes including complications in donors/recipients and overall mortality in recipients remained comparable.CONCLUSIONIIO during robotic RDH is safe. It led to reduced blood loss among donors and improved graft parameters in recipients during the immediate postoperative period.
{"title":"Intermittent Inflow Occlusion in Robotic Right Donor Hepatectomy: A Randomised Controlled Trial.","authors":"Rahul D Kunju,Christi Titus Varghese,Krishnanunni Nair,Shweta Mallick,Binoj Sivasankara Pillai Thankamony Amma,Ramachandran N Menon,Dinesh Balakrishnan,Unnikrishnan Gopalakrishnan,Sudheer Ov,S Sudhindran","doi":"10.1097/sla.0000000000006733","DOIUrl":"https://doi.org/10.1097/sla.0000000000006733","url":null,"abstract":"OBJECTIVETo assess the safety and efficacy of intermittent inflow occlusion (IIO) during robotic right donor hepatectomy (RDH) for adult living donor liver transplantation.SUMMARY BACKGROUND DATAAlthough evidence supports minimally invasive donor hepatectomy, its adoption by surgeons remains limited. Key challenges include bleeding during parenchymal transection and prolonged warm ischemia during graft extraction, resulting in morbidity in both the donor and recipient.METHODSBetween April 2022 and June 2023, out of 123 donors suitable for RDH, 113 were randomised to undergo robotic RDH with (n=56) or without (n=57) IIO. The primary endpoint was the blood loss during robotic RDH. The secondary end points included peak levels of bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), INR and complications in donors and recipients. Additionally, peak lactate levels and the need for blood transfusion were assessed in donors.RESULTSThe mean duration of IIO was 42.48±11.21 minutes .Blood loss during parenchymal transection (235 (186.25 - 375) vs. 295 (235 - 475),P=0.006) and total blood loss (275 (212.5 - 430) vs. 330 (272.5- 520),P=0.018) were significantly lower among donors in the IIO arm. In recipients belonging to IIO arm, peak ALT (P=0.032) and INR (P=0.012) were significantly low. Although statistically similar, the peak AST (P=0.064) and acute kidney injury (1,P=0.061) in the IIO arm among recipients were also less. Other perioperative outcomes including complications in donors/recipients and overall mortality in recipients remained comparable.CONCLUSIONIIO during robotic RDH is safe. It led to reduced blood loss among donors and improved graft parameters in recipients during the immediate postoperative period.","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":"108 1","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143857420","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-21DOI: 10.1097/sla.0000000000006741
Todd H Baron,Irving Jorge,Ali Husnain,Petros Constantino Benias,Bradley N Reames,Ashok Bhanushali,Salvatore Docimo,Matthew Bloom,Riad Salem,Patrick Murphy,Harjit Singh,Shyam Varadarajulu,Ahsun Riaz
OBJECTIVEReview the current literature for available treatments for acute cholecystitis (AC) in non-surgical candidates and provide guidelines for the management of these patients.BACKGROUNDCholecystectomy is the gold standard treatment modality for AC. A considerable number of patients who are not eligible for surgery are managed by percutaneous and endoscopic techniques. There is recent data regarding endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) and emerging percutaneous approaches to address cholelithiasis and remove drains.METHODSAn expert panel of surgeons, gastroenterologists, and interventional radiologists reviewed the current literature and provided recommendations for AC management in non-surgical candidates. Recommendations were based on relevant evidence, with quality and strength assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework.RESULTSPercutaneous cholecystostomy (PC) is advised for patients ineligible for lumen-apposing metal stent (LAMS) or with reversible conditions, aiming to bridge to cholecystectomy. The optimal timing of cholecystectomy after PC remains unclear. In cases where surgery is not feasible, potential definitive treatments such as percutaneous cholecysto-lithotripsy/lithectomy and cholecystoduodenal stenting should be considered. For calculous AC, EUS-GBD with LAMS is recommended as a therapy for never-surgical candidates if they are eligible for monitored anesthesia care or general anesthesia and there is institutional expertise and minimal intervening ascites.CONCLUSIONSThe management of AC in non-surgical candidates remains a challenge, with institutional protocols varying based on physician preferences and expertise. The proposed protocol integrates percutaneous and endoscopic approaches and emphasizes the need for multidisciplinary collaboration. Further research is required to evaluate these evolving management techniques, as the current literature is limited.
{"title":"Comprehensive Review of the Management of Patients with Acute Cholecystitis Who Are Ineligible for Surgery.","authors":"Todd H Baron,Irving Jorge,Ali Husnain,Petros Constantino Benias,Bradley N Reames,Ashok Bhanushali,Salvatore Docimo,Matthew Bloom,Riad Salem,Patrick Murphy,Harjit Singh,Shyam Varadarajulu,Ahsun Riaz","doi":"10.1097/sla.0000000000006741","DOIUrl":"https://doi.org/10.1097/sla.0000000000006741","url":null,"abstract":"OBJECTIVEReview the current literature for available treatments for acute cholecystitis (AC) in non-surgical candidates and provide guidelines for the management of these patients.BACKGROUNDCholecystectomy is the gold standard treatment modality for AC. A considerable number of patients who are not eligible for surgery are managed by percutaneous and endoscopic techniques. There is recent data regarding endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) and emerging percutaneous approaches to address cholelithiasis and remove drains.METHODSAn expert panel of surgeons, gastroenterologists, and interventional radiologists reviewed the current literature and provided recommendations for AC management in non-surgical candidates. Recommendations were based on relevant evidence, with quality and strength assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework.RESULTSPercutaneous cholecystostomy (PC) is advised for patients ineligible for lumen-apposing metal stent (LAMS) or with reversible conditions, aiming to bridge to cholecystectomy. The optimal timing of cholecystectomy after PC remains unclear. In cases where surgery is not feasible, potential definitive treatments such as percutaneous cholecysto-lithotripsy/lithectomy and cholecystoduodenal stenting should be considered. For calculous AC, EUS-GBD with LAMS is recommended as a therapy for never-surgical candidates if they are eligible for monitored anesthesia care or general anesthesia and there is institutional expertise and minimal intervening ascites.CONCLUSIONSThe management of AC in non-surgical candidates remains a challenge, with institutional protocols varying based on physician preferences and expertise. The proposed protocol integrates percutaneous and endoscopic approaches and emphasizes the need for multidisciplinary collaboration. Further research is required to evaluate these evolving management techniques, as the current literature is limited.","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":"35 1","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143857417","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-21DOI: 10.1097/sla.0000000000006738
Chase J Wehrle,Abby Gross,Sangeeta Satish,Kumaran Shanmugarajah,Toshihiro Nakayama,Christina M Fleischer,Kyle Sheetz,Federico Aucejo,Kazunari Sasaki,David Ch Kwon,Masato Fujiki,Antonio D Pinna,Charles Miller,Koji Hashimoto,Andrea Schlegel,Glenn K Wakam
SIGNIFICANCEWe evaluated the impact of OOS on organ utilization and also what factors impact the decision to employ OOS.BACKGROUNDDeceased donor liver allocation typically follows a ranked match-run of potential recipients. Organ procurement organizations (OPOs) may deviate from liver transplant standardized allocation using "out-of-sequence" (OOS) matches.METHODSAll eligible donors from the Scientific Registry of Transplant Recipients (SRTR) (1/1/2013-8/31/2023) were identified and merged with associated match-runs in the Potential Transplant Recipient (PTR) data. OOS offers were defined as bypass codes (861-863; 760-765). Hierarchical mixed-effects models with eligible donors nested in OPOs assessed OOS-practices versus organ utilization, controlling for liver graft risk with the Discard Risk Index (DSRI) by risk quintile, blood type, and year.RESULTSOOS were more common each progressive year. Neither TC's (R2<0.01) nor OPO's (R2<0.01) OOS-rate correlated with increased utilization. OOS was not associated with improved utilization (OR=1.11, 95%CI=0.90-1.38). Increasing graft risk in DBD&DCD grafts was associated with reduced utilization. Introducing OOS-allocation interaction terms improved utilization for DCD's of all risk levels but only improved utilization for DSRI 5th-Quintile DBD's. 38% of utilization was explained by graft factors versus 5% by TC-&OPO-variability (Conditional-R2=0.431, Marginal-R2=0.380). High-risk DCD grafts in DSRI 3rd-5th-Quintiles were not more likely to be allocated through OOS despite these grafts demonstrating improved utilization with this approach. Only 15% of variation in OOS-allocation was explained by graft factors versus 23% by TC-and OPO-variability (Conditional R2=0.388, Marginal R2=0.154).CONCLUSIONSOOS improves utilization in high-risk grafts, but graft risk is not correlated with their actual use. This highlights utility in OOS, but also that this practice is currently incorrectly used.
{"title":"Out of Sequence Allocation in Liver Transplantation: A Poorly Used Tool to Improve Organ Utilization.","authors":"Chase J Wehrle,Abby Gross,Sangeeta Satish,Kumaran Shanmugarajah,Toshihiro Nakayama,Christina M Fleischer,Kyle Sheetz,Federico Aucejo,Kazunari Sasaki,David Ch Kwon,Masato Fujiki,Antonio D Pinna,Charles Miller,Koji Hashimoto,Andrea Schlegel,Glenn K Wakam","doi":"10.1097/sla.0000000000006738","DOIUrl":"https://doi.org/10.1097/sla.0000000000006738","url":null,"abstract":"SIGNIFICANCEWe evaluated the impact of OOS on organ utilization and also what factors impact the decision to employ OOS.BACKGROUNDDeceased donor liver allocation typically follows a ranked match-run of potential recipients. Organ procurement organizations (OPOs) may deviate from liver transplant standardized allocation using \"out-of-sequence\" (OOS) matches.METHODSAll eligible donors from the Scientific Registry of Transplant Recipients (SRTR) (1/1/2013-8/31/2023) were identified and merged with associated match-runs in the Potential Transplant Recipient (PTR) data. OOS offers were defined as bypass codes (861-863; 760-765). Hierarchical mixed-effects models with eligible donors nested in OPOs assessed OOS-practices versus organ utilization, controlling for liver graft risk with the Discard Risk Index (DSRI) by risk quintile, blood type, and year.RESULTSOOS were more common each progressive year. Neither TC's (R2<0.01) nor OPO's (R2<0.01) OOS-rate correlated with increased utilization. OOS was not associated with improved utilization (OR=1.11, 95%CI=0.90-1.38). Increasing graft risk in DBD&DCD grafts was associated with reduced utilization. Introducing OOS-allocation interaction terms improved utilization for DCD's of all risk levels but only improved utilization for DSRI 5th-Quintile DBD's. 38% of utilization was explained by graft factors versus 5% by TC-&OPO-variability (Conditional-R2=0.431, Marginal-R2=0.380). High-risk DCD grafts in DSRI 3rd-5th-Quintiles were not more likely to be allocated through OOS despite these grafts demonstrating improved utilization with this approach. Only 15% of variation in OOS-allocation was explained by graft factors versus 23% by TC-and OPO-variability (Conditional R2=0.388, Marginal R2=0.154).CONCLUSIONSOOS improves utilization in high-risk grafts, but graft risk is not correlated with their actual use. This highlights utility in OOS, but also that this practice is currently incorrectly used.","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":"138 1","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143857418","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-16DOI: 10.1097/sla.0000000000006731
Reiping Huang,Sarah L Remer,Leandra K Knapp,Mark E Cohen,Michael A Rosen,Bruce L Hall,Elizabeth C Wick,Clifford Y Ko
OBJECTIVEThis study explains successful implementation of hospital enhanced recovery programs (ERPs) through unique configurations of contextual and implementation conditions.SUMMARY BACKGROUND DATADespite proven benefits in improving surgical outcomes, ERPs are often ineffectively implemented in hospitals, possibly due to the complex ways in which the interventions, local environment contexts, and implementation processes intertwine.METHODSUsing coincidence analysis, a mathematical method for analyzing configurations, we identified sufficient and necessary conditions for ERP implementation success in a national surgical collaborative. Success (high improvement) was defined as being among the 25% of hospitals with the greatest improvement in ERP adherence rate over time. Explanatory conditions included implementation resources in five domains (knowledge of evidence supporting interventions, leadership support, team skills and cohesion, stakeholder buy-in, and appropriate workload and time), organizational readiness to change, and hospital characteristics (teaching status, bed size, surgical volume, and socioeconomic status (SES) of patient populations). Prevalence-adjusted (PA) consistency and contrapositive (PAC) coverage, measures of data fit, were used in model selection adjusting for outcome prevalence.RESULTSOf the 86 hospitals, 26 (30.2%) successfully implemented ERP. Three scenarios collectively explained success for >70% of the hospitals (PA consistency=0.719, PAC coverage=0.752): Low-SES hospitals ready to change despite lacking team skills and cohesion during implementation; hospitals with low surgical volume which were ready to change and had strong staff buy-in; and high-volume hospitals that lacked leadership support but had appropriate workload and sufficient time for implementation rollout.CONCLUSIONSSuccessful ERP implementation varied by local context and relied on organizational readiness to change, strong staff buy-in, appropriate workload and sufficient time.
{"title":"Hospital Configurations Leading to Successful Implementation of Enhanced Recovery Programs.","authors":"Reiping Huang,Sarah L Remer,Leandra K Knapp,Mark E Cohen,Michael A Rosen,Bruce L Hall,Elizabeth C Wick,Clifford Y Ko","doi":"10.1097/sla.0000000000006731","DOIUrl":"https://doi.org/10.1097/sla.0000000000006731","url":null,"abstract":"OBJECTIVEThis study explains successful implementation of hospital enhanced recovery programs (ERPs) through unique configurations of contextual and implementation conditions.SUMMARY BACKGROUND DATADespite proven benefits in improving surgical outcomes, ERPs are often ineffectively implemented in hospitals, possibly due to the complex ways in which the interventions, local environment contexts, and implementation processes intertwine.METHODSUsing coincidence analysis, a mathematical method for analyzing configurations, we identified sufficient and necessary conditions for ERP implementation success in a national surgical collaborative. Success (high improvement) was defined as being among the 25% of hospitals with the greatest improvement in ERP adherence rate over time. Explanatory conditions included implementation resources in five domains (knowledge of evidence supporting interventions, leadership support, team skills and cohesion, stakeholder buy-in, and appropriate workload and time), organizational readiness to change, and hospital characteristics (teaching status, bed size, surgical volume, and socioeconomic status (SES) of patient populations). Prevalence-adjusted (PA) consistency and contrapositive (PAC) coverage, measures of data fit, were used in model selection adjusting for outcome prevalence.RESULTSOf the 86 hospitals, 26 (30.2%) successfully implemented ERP. Three scenarios collectively explained success for >70% of the hospitals (PA consistency=0.719, PAC coverage=0.752): Low-SES hospitals ready to change despite lacking team skills and cohesion during implementation; hospitals with low surgical volume which were ready to change and had strong staff buy-in; and high-volume hospitals that lacked leadership support but had appropriate workload and sufficient time for implementation rollout.CONCLUSIONSSuccessful ERP implementation varied by local context and relied on organizational readiness to change, strong staff buy-in, appropriate workload and sufficient time.","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":"34 1","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143841006","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-16DOI: 10.1097/sla.0000000000006735
Jonathan Garnier,Alessio Marchetti,Brady Campbell,Paul C M Andel,Marie-Sophie Alfano,Camila Hidalgo Salinas,Eddy Traversari,Joseph R Habib,Gabriella Lionetto,Anaïs Palen,Jacques Ewald,Kelly Lafaro,Daniel Brock Hewitt,Richard A Burkhart,Salvatore Paiella,Greg D Sacks,Guiseppe Malleo,Christopher L Wolfgang,Roberto Salvia,Jin He,Olivier Turrini,Ammar A Javed
OBJECTIVETo establish a novel method for evaluating carbohydrate antigen 19-9 (CA19-9) during neoadjuvant therapy (NAT) and assess its role in predicting overall (OS) and disease-free (DFS) survival in borderline resectable pancreatic adenocarcinoma (BR-PC).SUMMARY BACKGROUND DATAStatic CA19-9 values or percentage changes often fail to capture therapeutic responses in patients with BR-PC undergoing NAT. Improved evaluation methods are essential for guiding the treatment.METHODSThis was a retrospective multicenter study of patients who underwent BR-PC surgery. Two parameters were developed: slope coefficient (SC, change in CA19-9 divided by therapy duration) and mean δf (mδf, calculated as the sum of CA19-9 values over therapy intervals divided by the number of 15-day periods). The main objective was to correlate mδf with OS thresholds derived using a maximally selected log-rank statistic and validated in independent cohorts.RESULTSOverall, 991 patients (median age 65 [59-71] years; 49% male) were included. The thresholds for mδf were defined as U.mL-1. month-1 (negative SC) and U.mL-1. month-1 (positive SC). Patients with mδf below these thresholds had significantly better prognoses, with hazard ratios (HR) for OS (95% CI) of 0.6 (0.4-0.8; P<0.01) and 0.4 (0.2-0.9; P=0.04) for negative and positive SC, respectively. Both thresholds were validated for mOS, with 29 vs 22 months (P=0.015) and 32 vs 16 months (P=0.0034) for negative and positive SC, respectively. Similarly, the mDFS was 13 vs 10 months (P=0.011) and 12 vs 7 months (P=0.0018), respectively.CONCLUSIONThis CA19-9 evaluation approach accurately predicts survival outcomes, offering a valuable tool for optimizing treatment strategies. An mδf calculator is available at https://www.pancpals.com/tools.
{"title":"Carbohydrate Antigen 19-9 Delta Function for Survival Prediction in Borderline Pancreatic Cancer. A PANC-PALS Consortium International Multicenter Derivation and Validation Study.","authors":"Jonathan Garnier,Alessio Marchetti,Brady Campbell,Paul C M Andel,Marie-Sophie Alfano,Camila Hidalgo Salinas,Eddy Traversari,Joseph R Habib,Gabriella Lionetto,Anaïs Palen,Jacques Ewald,Kelly Lafaro,Daniel Brock Hewitt,Richard A Burkhart,Salvatore Paiella,Greg D Sacks,Guiseppe Malleo,Christopher L Wolfgang,Roberto Salvia,Jin He,Olivier Turrini,Ammar A Javed","doi":"10.1097/sla.0000000000006735","DOIUrl":"https://doi.org/10.1097/sla.0000000000006735","url":null,"abstract":"OBJECTIVETo establish a novel method for evaluating carbohydrate antigen 19-9 (CA19-9) during neoadjuvant therapy (NAT) and assess its role in predicting overall (OS) and disease-free (DFS) survival in borderline resectable pancreatic adenocarcinoma (BR-PC).SUMMARY BACKGROUND DATAStatic CA19-9 values or percentage changes often fail to capture therapeutic responses in patients with BR-PC undergoing NAT. Improved evaluation methods are essential for guiding the treatment.METHODSThis was a retrospective multicenter study of patients who underwent BR-PC surgery. Two parameters were developed: slope coefficient (SC, change in CA19-9 divided by therapy duration) and mean δf (mδf, calculated as the sum of CA19-9 values over therapy intervals divided by the number of 15-day periods). The main objective was to correlate mδf with OS thresholds derived using a maximally selected log-rank statistic and validated in independent cohorts.RESULTSOverall, 991 patients (median age 65 [59-71] years; 49% male) were included. The thresholds for mδf were defined as U.mL-1. month-1 (negative SC) and U.mL-1. month-1 (positive SC). Patients with mδf below these thresholds had significantly better prognoses, with hazard ratios (HR) for OS (95% CI) of 0.6 (0.4-0.8; P<0.01) and 0.4 (0.2-0.9; P=0.04) for negative and positive SC, respectively. Both thresholds were validated for mOS, with 29 vs 22 months (P=0.015) and 32 vs 16 months (P=0.0034) for negative and positive SC, respectively. Similarly, the mDFS was 13 vs 10 months (P=0.011) and 12 vs 7 months (P=0.0018), respectively.CONCLUSIONThis CA19-9 evaluation approach accurately predicts survival outcomes, offering a valuable tool for optimizing treatment strategies. An mδf calculator is available at https://www.pancpals.com/tools.","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":"37 1","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143841260","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
OBJECTIVEThis randomized phase II/III study evaluated the superiority of neoadjuvant therapy with gemcitabine plus S-1 over upfront surgery for patients with resectable pancreatic ductal adenocarcinoma (PDAC).SUMMARY BACKGROUND DATAPancreatic ductal adenocarcinoma is a leading cause of cancer mortality that urgently requires better treatment.METHODSPatients with resectable PDAC (without arterial abutment) were randomly assigned to upfront surgery or neoadjuvant chemotherapy with gemcitabine (1000 mg/m2 days 1 and 8) and S-1 (40-60 mg orally twice daily, days 1-14 every 3 wk for 2 cycles). Phase II and III primary endpoints were resection rate and overall survival, respectively. UMIN Clinical Trials Registry number: UMIN000009634.RESULTSPatients (n=364) were enrolled and randomly allocated to upfront surgery (UPS; n=182) or neoadjuvant gemcitabine plus S-1 (NAC-GS; n=182). Patient demographics and tumor characteristics were balanced between groups. Median overall survival in the UPS and NAC-GS groups was 26.6 (95% confidence interval [CI] 21.5, 31.5) and 37.0 (95% CI 28.6, 43.3) months, respectively. The hazard ratio for mortality in the NAC-GS group compared with the UPS group was 0.73 (95% CI 0.56, 0.95; P=0.018). Median relapse-free survival in the UPS and NAC-GS groups was 11.3 (95% CI 9.41, 13.5) and 14.3 (95% CI 11.7, 17.0) months, respectively. The hazard ratio for relapse in the NAC-GS group compared with the UPS group was 0.77 (95% CI 0.61, 0.98; P=0.030).CONCLUSIONThe Prep-02/JSAP05 trial results showed that neoadjuvant chemotherapy with gemcitabine plus S-1 significantly extends survival compared with upfront surgery in patients with resectable PDAC.
{"title":"Neoadjuvant Chemotherapy with Gemcitabine and S-1 versus Upfront Surgery for Resectable Pancreatic Cancer: Results of the Randomized Phase II/III Prep-02/JSAP05 Trial.","authors":"Michiaki Unno,Fuyuhiko Motoi,Yutaka Matsuyama,Sohei Satoi,Hirochika Toyama,Ippei Matsumoto,Suefumi Aosasa,Hirofumi Shirakawa,Keita Wada,Tsutomu Fujii,Hideyuki Yoshitomi,Shinichiro Takahashi,Masayuki Sho,Hideki Ueno,Tomoo Kosuge","doi":"10.1097/sla.0000000000006730","DOIUrl":"https://doi.org/10.1097/sla.0000000000006730","url":null,"abstract":"OBJECTIVEThis randomized phase II/III study evaluated the superiority of neoadjuvant therapy with gemcitabine plus S-1 over upfront surgery for patients with resectable pancreatic ductal adenocarcinoma (PDAC).SUMMARY BACKGROUND DATAPancreatic ductal adenocarcinoma is a leading cause of cancer mortality that urgently requires better treatment.METHODSPatients with resectable PDAC (without arterial abutment) were randomly assigned to upfront surgery or neoadjuvant chemotherapy with gemcitabine (1000 mg/m2 days 1 and 8) and S-1 (40-60 mg orally twice daily, days 1-14 every 3 wk for 2 cycles). Phase II and III primary endpoints were resection rate and overall survival, respectively. UMIN Clinical Trials Registry number: UMIN000009634.RESULTSPatients (n=364) were enrolled and randomly allocated to upfront surgery (UPS; n=182) or neoadjuvant gemcitabine plus S-1 (NAC-GS; n=182). Patient demographics and tumor characteristics were balanced between groups. Median overall survival in the UPS and NAC-GS groups was 26.6 (95% confidence interval [CI] 21.5, 31.5) and 37.0 (95% CI 28.6, 43.3) months, respectively. The hazard ratio for mortality in the NAC-GS group compared with the UPS group was 0.73 (95% CI 0.56, 0.95; P=0.018). Median relapse-free survival in the UPS and NAC-GS groups was 11.3 (95% CI 9.41, 13.5) and 14.3 (95% CI 11.7, 17.0) months, respectively. The hazard ratio for relapse in the NAC-GS group compared with the UPS group was 0.77 (95% CI 0.61, 0.98; P=0.030).CONCLUSIONThe Prep-02/JSAP05 trial results showed that neoadjuvant chemotherapy with gemcitabine plus S-1 significantly extends survival compared with upfront surgery in patients with resectable PDAC.","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":"3 1","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143841259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-16DOI: 10.1097/sla.0000000000006734
Christy Cauley,Atziri Rubio-Chavez,Zara Cooper,Sevdenur Cizginer,Ana Maria Vranceanu,Christine S Ritchie
OBJECTIVEUnderstand challenges faced by older adults who undergo elective major surgery.BACKGROUNDPreparation for and recovery from elective major surgery is often described from clinician perspectives, limiting insights into older patients' experiences.METHODSWe conducted a qualitative study with adults age 65+ years, 30-90 days post colectomy, using interviews and surveys at a Northeastern U.S. tertiary surgical clinic. Guided by a modified Framework method, we arranged data into domains, themes and subthemes. We categorized patient-identified challenges using the Geriatric 5 Ms framework as deductive themes. Then, we identified additional themes and subthemes inductively.RESULTSFrom November 2022 to August 2023, twenty patients completed the study. Themes of personal patient challenges included: the mind (i.e., coping with uncertainty, anxiety/frustration, and underappreciated cognitive challenges), mobility (i.e., physical limitations and challenges completing activities of daily living), medications (i.e., understanding medication frequency and side effects), multi-complexity (i.e., surgical recovery in the context of multi-morbidity), and what matters most (i.e., matters related to self, care-partners, and recovery expectations). Themes of process characteristics included challenges discussing the decision for surgery, understanding expectations for surgical recovery, and obtaining anticipatory guidance. Patients with fecal ostomy described heightened emotional challenges and social support needs.CONCLUSIONSModifiable challenges older adult patients perceive after elective major surgery often stemmed from perioperative anxiety, uncertainty, inadequate communication and insufficient social support. These findings can guide clinicians in optimizing surgical care and inform future research developing interventions aimed at addressing emotional stressors and enhancing communication between patients and surgical teams.
{"title":"Perspectives of Older Adults Undergoing Elective Major Surgery: A Qualitative Study of Patients Undergoing Colectomy.","authors":"Christy Cauley,Atziri Rubio-Chavez,Zara Cooper,Sevdenur Cizginer,Ana Maria Vranceanu,Christine S Ritchie","doi":"10.1097/sla.0000000000006734","DOIUrl":"https://doi.org/10.1097/sla.0000000000006734","url":null,"abstract":"OBJECTIVEUnderstand challenges faced by older adults who undergo elective major surgery.BACKGROUNDPreparation for and recovery from elective major surgery is often described from clinician perspectives, limiting insights into older patients' experiences.METHODSWe conducted a qualitative study with adults age 65+ years, 30-90 days post colectomy, using interviews and surveys at a Northeastern U.S. tertiary surgical clinic. Guided by a modified Framework method, we arranged data into domains, themes and subthemes. We categorized patient-identified challenges using the Geriatric 5 Ms framework as deductive themes. Then, we identified additional themes and subthemes inductively.RESULTSFrom November 2022 to August 2023, twenty patients completed the study. Themes of personal patient challenges included: the mind (i.e., coping with uncertainty, anxiety/frustration, and underappreciated cognitive challenges), mobility (i.e., physical limitations and challenges completing activities of daily living), medications (i.e., understanding medication frequency and side effects), multi-complexity (i.e., surgical recovery in the context of multi-morbidity), and what matters most (i.e., matters related to self, care-partners, and recovery expectations). Themes of process characteristics included challenges discussing the decision for surgery, understanding expectations for surgical recovery, and obtaining anticipatory guidance. Patients with fecal ostomy described heightened emotional challenges and social support needs.CONCLUSIONSModifiable challenges older adult patients perceive after elective major surgery often stemmed from perioperative anxiety, uncertainty, inadequate communication and insufficient social support. These findings can guide clinicians in optimizing surgical care and inform future research developing interventions aimed at addressing emotional stressors and enhancing communication between patients and surgical teams.","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":"108 1","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143841073","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
OBJECTIVETo evaluate the impact of preoperative analgesic education on postoperative opioid consumption, pain scores, and patient satisfaction with analgesia.BACKGROUNDEffective postoperative pain management is crucial for patient recovery and satisfaction, yet opioid use poses risks of tolerance and addiction. Preoperative patient education offers a potential avenue to mitigate opioid reliance and improve pain management outcomes.METHODSThis single-center randomized controlled trial was conducted at the Cleveland Clinic Main Campus between October 2021 and October 2023. Adult patients scheduled for hip arthroplasty or laparoscopic-assisted abdominal surgery with an ASA physical status of 1-4 were eligible. Patients with a history of prolonged opioid use, planned regional block or epidural analgesia, or limited English fluency were excluded. Participants were randomized 1:1 to receive either an analgesic educational video or a generic video about surgery and hospitalization. The primary outcome was opioid consumption during the initial 72 postoperative hours. Secondary outcomes included time-weighted average pain scores and patient satisfaction with analgesia.RESULTSAmong 957 analyzed patients, preoperative analgesic education did not significantly reduce opioid consumption (adjusted ratio of geometric means, 1.01; 95% CI, 0.86 to 1.18; P = 0.890) or improve pain scores (adjusted mean difference, -0.1; 95% CI, -0.3 to 0.2; P = 0.617). Patient satisfaction scores also did not differ significantly between groups (adjusted mean difference, -0.1; 95% CI, -0.3 to 0.2; P = 0.611).CONCLUSIONSPreoperative analgesic education did not result in clinically meaningful reductions in opioid consumption or improvements in pain management outcomes. Further research may explore more intensive educational interventions to optimize postoperative pain management strategies.
{"title":"Preoperative Patient Education on Opioid Use and Pain after Surgery: A Randomized Trial.","authors":"Alparslan Turan,Tyler Karras,Sara Medellin,Amita Kharabe,Elyad Ekrami,Jiayi Wang,Esra Kutlu Yalcin,Karan Shah,Kenneth Cummings,Kurt Ruetzler,Daniel I Sessler,","doi":"10.1097/sla.0000000000006717","DOIUrl":"https://doi.org/10.1097/sla.0000000000006717","url":null,"abstract":"OBJECTIVETo evaluate the impact of preoperative analgesic education on postoperative opioid consumption, pain scores, and patient satisfaction with analgesia.BACKGROUNDEffective postoperative pain management is crucial for patient recovery and satisfaction, yet opioid use poses risks of tolerance and addiction. Preoperative patient education offers a potential avenue to mitigate opioid reliance and improve pain management outcomes.METHODSThis single-center randomized controlled trial was conducted at the Cleveland Clinic Main Campus between October 2021 and October 2023. Adult patients scheduled for hip arthroplasty or laparoscopic-assisted abdominal surgery with an ASA physical status of 1-4 were eligible. Patients with a history of prolonged opioid use, planned regional block or epidural analgesia, or limited English fluency were excluded. Participants were randomized 1:1 to receive either an analgesic educational video or a generic video about surgery and hospitalization. The primary outcome was opioid consumption during the initial 72 postoperative hours. Secondary outcomes included time-weighted average pain scores and patient satisfaction with analgesia.RESULTSAmong 957 analyzed patients, preoperative analgesic education did not significantly reduce opioid consumption (adjusted ratio of geometric means, 1.01; 95% CI, 0.86 to 1.18; P = 0.890) or improve pain scores (adjusted mean difference, -0.1; 95% CI, -0.3 to 0.2; P = 0.617). Patient satisfaction scores also did not differ significantly between groups (adjusted mean difference, -0.1; 95% CI, -0.3 to 0.2; P = 0.611).CONCLUSIONSPreoperative analgesic education did not result in clinically meaningful reductions in opioid consumption or improvements in pain management outcomes. Further research may explore more intensive educational interventions to optimize postoperative pain management strategies.","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":"34 1","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143831684","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-11DOI: 10.1097/sla.0000000000006732
Aksel D Laudon,Jeffrey A Franks,Elizabeth S Davis,Xuewei Zhao,Kelly Kenzik,Crisanto M Torres,Sophia Smith,Lisa Allee,Dane R Scantling
OBJECTIVEWe sought to identify which absent firearm laws would have prevented the most firearm suicides (FS) in each state of the US.SUMMARY BACKGROUND DATAPrior studies suggested efficacy for FS prevention varies greatly between different firearm laws. However, this body of work did not probe how this efficacy may differ by state.METHODSThis state-level, retrospective cohort study of firearm laws among the contiguous United States from 2010-2019 used Poisson models for the association between state FS per 100,000 population and implementation of state firearm laws lagged by 7 years, spatially weighted total firearm laws in surrounding states, and state demographics. These models were applied to each absent law in each state to estimate the reduction in FS associated with law implementation. The law associated with the greatest reduction in each state was the most impactful missing law.RESULTSEight of 12 law categories were significantly associated with decreased FS rates. The largest associated reductions in FS were with child access prevention, or CAP (IRR 0.53; 95% CI 0.48-0.59; P<0.001), and concealed carry permitting, or CCP (IRR 0.59; 95% CI 0.54-0.65; P<0.001). Five states had all law categories for the study duration, and CAP and CCP were the most impactful missing law categories in 22 (51%) and 9 (21%) of remaining states, respectively. A total of 114,106 FS were associated with all states not having implemented their most effective missing law category across the study period.CONCLUSIONSThis study found that FS rates in most states would have decreased most with passage of CAP or CCP, which can inform policymaking in respective states.
{"title":"110,000 Preventable Deaths: The Most Impactful Gaps in Firearm Suicide Prevention Laws 2010-2019.","authors":"Aksel D Laudon,Jeffrey A Franks,Elizabeth S Davis,Xuewei Zhao,Kelly Kenzik,Crisanto M Torres,Sophia Smith,Lisa Allee,Dane R Scantling","doi":"10.1097/sla.0000000000006732","DOIUrl":"https://doi.org/10.1097/sla.0000000000006732","url":null,"abstract":"OBJECTIVEWe sought to identify which absent firearm laws would have prevented the most firearm suicides (FS) in each state of the US.SUMMARY BACKGROUND DATAPrior studies suggested efficacy for FS prevention varies greatly between different firearm laws. However, this body of work did not probe how this efficacy may differ by state.METHODSThis state-level, retrospective cohort study of firearm laws among the contiguous United States from 2010-2019 used Poisson models for the association between state FS per 100,000 population and implementation of state firearm laws lagged by 7 years, spatially weighted total firearm laws in surrounding states, and state demographics. These models were applied to each absent law in each state to estimate the reduction in FS associated with law implementation. The law associated with the greatest reduction in each state was the most impactful missing law.RESULTSEight of 12 law categories were significantly associated with decreased FS rates. The largest associated reductions in FS were with child access prevention, or CAP (IRR 0.53; 95% CI 0.48-0.59; P<0.001), and concealed carry permitting, or CCP (IRR 0.59; 95% CI 0.54-0.65; P<0.001). Five states had all law categories for the study duration, and CAP and CCP were the most impactful missing law categories in 22 (51%) and 9 (21%) of remaining states, respectively. A total of 114,106 FS were associated with all states not having implemented their most effective missing law category across the study period.CONCLUSIONSThis study found that FS rates in most states would have decreased most with passage of CAP or CCP, which can inform policymaking in respective states.","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":"66 1","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143822619","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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