Background and aim: Outcomes of drainage in hilar biliary obstruction may depend on volume of liver drained with previous studies showing better survival if more volume is drained. We aimed at determining the effect of draining > 50% of liver volume on clinical success after intervention in complex hilar blocks.
Methods: In this prospective observational study, advanced unresectable malignant hilar biliary obstruction with Bismuth-Corlette type II and above were recruited prospectively from October 2022 till April 2024. Patients underwent computed tomography (CT) abdomen and volumetric analysis using TeraRecon™ software. Patients were then subjected to endoscopic or percutaneous drainage. Based on intra-procedure details, patients were categorized into those achieving ≥ 50% (group A) and < 50% (group B) drainage groups. The primary outcome was clinical success. Secondary outcomes were complete drainage, cholangitis, reinterventions and overall survival.
Results: Eighty patients (mean age 54.9 ± 13.59 years; 53.8% females) were analyzed in the study. Forty-eight patients (60%) underwent ≥ 50% drainage. Clinical success was achieved in 47 patients (58.75%). Clinical success was achieved in 35 out of 48 (72.9%) and 12 out of 32 (37.5%) in group A and B, respectively. Clinical success was significantly higher in the ≥ 50% drainage group (OR 3.411; p = 0.025), with lesser cholangitis (15% vs. 26.3%; p = 0.001), reinterventions (12.5% vs. 23.8%; p = 0.001) and improved 90-day survival (58.8% vs. 10%; p = 0.013). On multivariate analysis, clinical success was a significant predictor for lesser episodes of cholangitis, reduced reinterventions, with higher complete drainage.
Conclusion: More than or equal to 50% biliary drainage leads to better clinical success and improved 90-day survival, with lesser cholangitis and lesser biliary reintervention rate. CT volumetry acts as a guiding tool.
背景和目的:肝门胆道梗阻的引流结果可能取决于肝引流的体积,先前的研究表明,如果肝引流的体积越大,生存率越高。我们的目的是确定在复杂肝门阻塞干预后,引流50%肝容量对临床成功的影响。方法:在这项前瞻性观察研究中,于2022年10月至2024年4月前瞻性招募晚期不可切除的Bismuth-Corlette II型及以上恶性肝门胆道梗阻。患者使用TeraRecon™软件进行腹部计算机断层扫描(CT)和体积分析。然后患者接受内窥镜或经皮引流。根据术中细节,将患者分为≥50% (A组)。结果:80例患者(平均年龄54.9±13.59岁,女性53.8%)纳入研究。48例(60%)患者≥50%引流。临床成功47例(58.75%)。A组48例中35例(72.9%)临床成功,B组32例中12例(37.5%)临床成功。≥50%引流组的临床成功率显著高于对照组(OR 3.411, p = 0.025),胆管炎发生率降低(15% vs. 26.3%, p = 0.001),再干预率降低(12.5% vs. 23.8%, p = 0.001), 90天生存率提高(58.8% vs. 10%, p = 0.013)。在多变量分析中,临床成功是减少胆管炎发作、减少再干预和更高的完全引流的重要预测因素。结论:≥50%胆道引流可提高临床成功率,提高90天生存率,减少胆管炎和胆道再干预率。CT体积测量作为指导工具。
{"title":"Efficacy of ≥ 50% biliary drainage in advanced unresectable malignant hilar biliary obstruction: A prospective study.","authors":"Rishikesh Malokar, Shubham Jain, Manisha Joshi, Prasanta Debnath, Anuraag Jena, Siddhesh Rane, Sameet Patel, Harsh Gandhi, Jay Chudasama, Deepika Pandey, Vishal Mavuri, Sridhar Sundaram, Sanjay Chandnani, Pravin Rathi","doi":"10.1007/s12664-025-01875-4","DOIUrl":"https://doi.org/10.1007/s12664-025-01875-4","url":null,"abstract":"<p><strong>Background and aim: </strong>Outcomes of drainage in hilar biliary obstruction may depend on volume of liver drained with previous studies showing better survival if more volume is drained. We aimed at determining the effect of draining > 50% of liver volume on clinical success after intervention in complex hilar blocks.</p><p><strong>Methods: </strong>In this prospective observational study, advanced unresectable malignant hilar biliary obstruction with Bismuth-Corlette type II and above were recruited prospectively from October 2022 till April 2024. Patients underwent computed tomography (CT) abdomen and volumetric analysis using TeraRecon™ software. Patients were then subjected to endoscopic or percutaneous drainage. Based on intra-procedure details, patients were categorized into those achieving ≥ 50% (group A) and < 50% (group B) drainage groups. The primary outcome was clinical success. Secondary outcomes were complete drainage, cholangitis, reinterventions and overall survival.</p><p><strong>Results: </strong>Eighty patients (mean age 54.9 ± 13.59 years; 53.8% females) were analyzed in the study. Forty-eight patients (60%) underwent ≥ 50% drainage. Clinical success was achieved in 47 patients (58.75%). Clinical success was achieved in 35 out of 48 (72.9%) and 12 out of 32 (37.5%) in group A and B, respectively. Clinical success was significantly higher in the ≥ 50% drainage group (OR 3.411; p = 0.025), with lesser cholangitis (15% vs. 26.3%; p = 0.001), reinterventions (12.5% vs. 23.8%; p = 0.001) and improved 90-day survival (58.8% vs. 10%; p = 0.013). On multivariate analysis, clinical success was a significant predictor for lesser episodes of cholangitis, reduced reinterventions, with higher complete drainage.</p><p><strong>Conclusion: </strong>More than or equal to 50% biliary drainage leads to better clinical success and improved 90-day survival, with lesser cholangitis and lesser biliary reintervention rate. CT volumetry acts as a guiding tool.</p>","PeriodicalId":13404,"journal":{"name":"Indian Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145336952","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-17DOI: 10.1007/s12664-025-01859-4
Vijesh V S, Santhosh E Kumar, Tulasi Geevar, Gayathiri K Chellaiya, Vinoi G David, Santosh Varughese, Binila Chacko, Ebor Jacob Gnanayagam, Joy Mammen, Dolly Daniel, Ashish Goel, Sukesh C Nair, C E Eapen, Uday George Zachariah
Background and objective: Plasma exchange (PLEX) is used to treat liver failure patients who have coagulopathy. There is no consensus regarding pre-procedural blood product transfusion prior to PLEX port placement among patients with acute liver failure (ALF) and acute-on-chronic liver failure (ACLF). The primary objective was to study the difference in prophylactic blood product use in patients with ALF and ACLF who had rotational thromboelastometry (ROTEM) done prior to PLEX port insertion (ROTEM group -RG) compared with those patients in whom ROTEM was not done (conventional coagulation group-CG). Secondary objectives were to study local port site-related bleeding events between these groups and the correlation between ROTEM parameters and conventional coagulation tests (CCT), in patients with ALF and ACLF.
Methods: We retrospectively analyzed consecutive patients who underwent PLEX for ALF and ACLF using central venous access (11.5 F and 10 F catheter for adult and pediatric patients, respectively) between October 2016 and February 2022. The prophylactic transfusion strategy in CG was based on CCT and RG was based on CCT and ROTEM parameters. Propensity score matching (PSM) was done separately for ALF and ACLF between RG and CG.
Results: Total 88/113 patients with ALF/ACLF underwent PLEX. In PSM matched 77 ALF/108 ACLF patients, prophylactic blood products use was significantly less in RG (18/50 [36%]/12/85 [14%]) compared CG (21/27 [78%]/18/23 [78%]; p < 0.001). Local port site bleeding events were noted in two ACLF patients (one in RG and one in CG) and none in ALF. In ALF/ACLF patients, the correlation between clotting time (CT, ROTEM) and prothrombin time international normalized ratio (PT-INR, CCT) was 0.29/0.35 (weak), respectively, between maximum clot firmness (MCF, ROTEM) and fibrinogen was 0.68/0.76 (strong), respectively, and between maximum clot firmness (MCF, ROTEM) and platelet was 0.56/0.71 (moderate/strong), respectively.
Conclusion: The use of a ROTEM-based transfusion strategy prior to PLEX port insertion helped reduce prophylactic blood product transfusion among patients with ALF and ACLF.
{"title":"Rotational thromboelastometry helped reduce prophylactic blood product use for port insertion in patients with liver failure undergoing plasma exchange.","authors":"Vijesh V S, Santhosh E Kumar, Tulasi Geevar, Gayathiri K Chellaiya, Vinoi G David, Santosh Varughese, Binila Chacko, Ebor Jacob Gnanayagam, Joy Mammen, Dolly Daniel, Ashish Goel, Sukesh C Nair, C E Eapen, Uday George Zachariah","doi":"10.1007/s12664-025-01859-4","DOIUrl":"https://doi.org/10.1007/s12664-025-01859-4","url":null,"abstract":"<p><strong>Background and objective: </strong>Plasma exchange (PLEX) is used to treat liver failure patients who have coagulopathy. There is no consensus regarding pre-procedural blood product transfusion prior to PLEX port placement among patients with acute liver failure (ALF) and acute-on-chronic liver failure (ACLF). The primary objective was to study the difference in prophylactic blood product use in patients with ALF and ACLF who had rotational thromboelastometry (ROTEM) done prior to PLEX port insertion (ROTEM group -RG) compared with those patients in whom ROTEM was not done (conventional coagulation group-CG). Secondary objectives were to study local port site-related bleeding events between these groups and the correlation between ROTEM parameters and conventional coagulation tests (CCT), in patients with ALF and ACLF.</p><p><strong>Methods: </strong>We retrospectively analyzed consecutive patients who underwent PLEX for ALF and ACLF using central venous access (11.5 F and 10 F catheter for adult and pediatric patients, respectively) between October 2016 and February 2022. The prophylactic transfusion strategy in CG was based on CCT and RG was based on CCT and ROTEM parameters. Propensity score matching (PSM) was done separately for ALF and ACLF between RG and CG.</p><p><strong>Results: </strong>Total 88/113 patients with ALF/ACLF underwent PLEX. In PSM matched 77 ALF/108 ACLF patients, prophylactic blood products use was significantly less in RG (18/50 [36%]/12/85 [14%]) compared CG (21/27 [78%]/18/23 [78%]; p < 0.001). Local port site bleeding events were noted in two ACLF patients (one in RG and one in CG) and none in ALF. In ALF/ACLF patients, the correlation between clotting time (CT, ROTEM) and prothrombin time international normalized ratio (PT-INR, CCT) was 0.29/0.35 (weak), respectively, between maximum clot firmness (MCF, ROTEM) and fibrinogen was 0.68/0.76 (strong), respectively, and between maximum clot firmness (MCF, ROTEM) and platelet was 0.56/0.71 (moderate/strong), respectively.</p><p><strong>Conclusion: </strong>The use of a ROTEM-based transfusion strategy prior to PLEX port insertion helped reduce prophylactic blood product transfusion among patients with ALF and ACLF.</p>","PeriodicalId":13404,"journal":{"name":"Indian Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145312683","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-10DOI: 10.1007/s12664-025-01851-y
Kymentie Ferdinande, Marco Senzolo
{"title":"Rethinking pre-procedural coagulation management in acute liver failure and acute-on-chronic liver failure: The emerging role of rotational thromboelastometry.","authors":"Kymentie Ferdinande, Marco Senzolo","doi":"10.1007/s12664-025-01851-y","DOIUrl":"https://doi.org/10.1007/s12664-025-01851-y","url":null,"abstract":"","PeriodicalId":13404,"journal":{"name":"Indian Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274591","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-10DOI: 10.1007/s12664-025-01881-6
Amerta Ghosh, Anoop Misra
{"title":"From abdominal adiposity to liver fibrosis: Expanding promise of semaglutide for Asian Indians.","authors":"Amerta Ghosh, Anoop Misra","doi":"10.1007/s12664-025-01881-6","DOIUrl":"https://doi.org/10.1007/s12664-025-01881-6","url":null,"abstract":"","PeriodicalId":13404,"journal":{"name":"Indian Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274552","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background and objectives: Obesity is a leading risk factor for fatty liver disease and weight loss has been shown to improve liver parameters. This study evaluates the efficacy of oral semaglutide for weight loss in individuals with overweight or obesity, excluding those with diabetes mellitus.
Methods: A randomized, open-label, controlled trial was conducted at the Asian Institute of Gastroenterology, Hyderabad, from June 2022 to December 2023. Adults (≥ 18 years) with a body mass index (BMI) ≥ 30 or ≥ 27 with comorbidities (pre-diabetes, hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease) were randomized into two groups. Both groups received counselling on a reduced-calorie diet and increased physical activity. Group 1 also received oral semaglutide, starting at 3 mg/day and titrated to 14 mg/day over two to four weeks. The objectives were to assess the effects of semaglutide on weight loss, non-invasive markers of liver fibrosis and cardiometabolic parameters. (ClinicalTrials.gov ID: NCT05442450).
Results: Total 116 participants (58 per group) completed the study. At 28 weeks, the mean percentage weight reduction was -10.47% (SD 5.3) in the Semaglutide group vs. -2.4% (SD 4.5) in the control group (p < 0.001). Semaglutide treatment significantly improved alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase [SGPT]) levels, along with reductions in the aspartate aminotransferase to platelet ratio index (APRI) score, liver fat content and liver stiffness. However, NFS (NAFLD fibrosis score) and FIB-4 (fibrosis-4 index) did not show significant reductions. Improvements in BMI, waist circumference, HbA1c, fasting insulin and C-reactive protein (CRP) were significantly greater with semaglutide (p < 0.001). Total fat mass decreased by 7.3 kg vs. 1.74 kg (p < 0.0001) in controls, while visceral fat ratings dropped by 3.67 vs. 0.6 (p < 0.0001).
Conclusions: In adults with overweight or obesity without diabetes, oral semaglutide, combined with dietary and lifestyle modifications, led to significant and clinically meaningful weight loss and metabolic improvements compared to lifestyle modifications alone.
{"title":"Oral semaglutide for weight loss and liver fibrosis in overweight and obesity: A randomized controlled trial.","authors":"Anudeep Katrevula, Rakesh Kalapala, Siddhant Agrawal, Nitin Jagtap, Pratik Chhabra, Anand V Kulkarni, Chandhana Merugu, Goutham Reddy Katukuri, Nageshwar Reddy Duvvur","doi":"10.1007/s12664-025-01856-7","DOIUrl":"https://doi.org/10.1007/s12664-025-01856-7","url":null,"abstract":"<p><strong>Background and objectives: </strong>Obesity is a leading risk factor for fatty liver disease and weight loss has been shown to improve liver parameters. This study evaluates the efficacy of oral semaglutide for weight loss in individuals with overweight or obesity, excluding those with diabetes mellitus.</p><p><strong>Methods: </strong>A randomized, open-label, controlled trial was conducted at the Asian Institute of Gastroenterology, Hyderabad, from June 2022 to December 2023. Adults (≥ 18 years) with a body mass index (BMI) ≥ 30 or ≥ 27 with comorbidities (pre-diabetes, hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease) were randomized into two groups. Both groups received counselling on a reduced-calorie diet and increased physical activity. Group 1 also received oral semaglutide, starting at 3 mg/day and titrated to 14 mg/day over two to four weeks. The objectives were to assess the effects of semaglutide on weight loss, non-invasive markers of liver fibrosis and cardiometabolic parameters. (ClinicalTrials.gov ID: NCT05442450).</p><p><strong>Results: </strong>Total 116 participants (58 per group) completed the study. At 28 weeks, the mean percentage weight reduction was -10.47% (SD 5.3) in the Semaglutide group vs. -2.4% (SD 4.5) in the control group (p < 0.001). Semaglutide treatment significantly improved alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase [SGPT]) levels, along with reductions in the aspartate aminotransferase to platelet ratio index (APRI) score, liver fat content and liver stiffness. However, NFS (NAFLD fibrosis score) and FIB-4 (fibrosis-4 index) did not show significant reductions. Improvements in BMI, waist circumference, HbA1c, fasting insulin and C-reactive protein (CRP) were significantly greater with semaglutide (p < 0.001). Total fat mass decreased by 7.3 kg vs. 1.74 kg (p < 0.0001) in controls, while visceral fat ratings dropped by 3.67 vs. 0.6 (p < 0.0001).</p><p><strong>Conclusions: </strong>In adults with overweight or obesity without diabetes, oral semaglutide, combined with dietary and lifestyle modifications, led to significant and clinically meaningful weight loss and metabolic improvements compared to lifestyle modifications alone.</p>","PeriodicalId":13404,"journal":{"name":"Indian Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145250957","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background and objectives: Anti-reflux mucosal ablation (ARMA) is a minimally invasive therapy for patients with proton pump inhibitor (PPI) controlled gastro-esophageal reflux disease (GERD). This study evaluated the safety and efficacy of ARMA over 12 months.
Methods: This single-center prospective study included PPI-dependent GERD patients (acid exposure time [AET] > 6% or AET > 4.2% with reflux episodes > 80 on 24-h-pH-impedance monitoring). ARMA was performed in a standardized fashion using hybrid technique (sub-mucosal lift followed by ablation). Patients were evaluated using the GERD health-related quality of life questionnaire (HRQL) at baseline, three months and 12 months, with 24-h-pH-impedance monitoring at baseline and 12 months.
Results: Total 216 patients (67.1% males, mean age = 38.7 years) underwent ARMA. At baseline, 123 (56.9%) patients had Hill's grade I and 93 (43.1%) had Hill's grade II on endoscopy. Ninety (41.7%) patients had Los Angeles (LA) grade A and 2 (0.93%) had LA grade B. There was a significant improvement in GERD-HRQL score from 43.8 (12.6) at baseline to 20.6 (13.8) at three months and to 8.3 (12.3) at 12 months (p = 0.001). The mean (SD) heartburn and regurgitation scores improved from 22.9 (10.8) and 20.6 (9.4) at baseline to 11.1 (8.7) and 9.5 (8.7) at three months and 3.9 (6.9) and 3.9 (6.9) at 12 months, respectively (p = 0.001). The AET (median [IQR]) decreased from 11.9 (15.9) to 7.6 (10.8) (n = 125, p = 0.009) at 12 months and the median DeMeester score reduced from 42.4 (47.1) to 26.2 (32.3) (p = 0.001). There was also a significant decrease in number of patients with AET 4% to 6% and > 6% and reflux episodes 40-80 and > 80 and DeMeester score > 14.72, as well as an increase in patients with AET < 4% and reflux episodes < 40. There was a significant improvement in Hill's grading and endoscopic esophagitis at one year. No major adverse events were observed.
Conclusion: In PPI-dependent GERD patients, ARMA resulted in sustained symptom reduction and improved quality of life at 12 months. This procedure is relatively simple, widely accessible and has a good safety profile.
{"title":"Efficacy and safety of anti-reflux mucosal ablation therapy at 12 months.","authors":"Krithi Krishna Koduri, Neeraj Singla, Rajesh Goud Maragoni, Nitin Jagtap, Aniruddha Pratap Singh, Rakesh Kalapala, D Nageshwar Reddy","doi":"10.1007/s12664-025-01761-z","DOIUrl":"10.1007/s12664-025-01761-z","url":null,"abstract":"<p><strong>Background and objectives: </strong>Anti-reflux mucosal ablation (ARMA) is a minimally invasive therapy for patients with proton pump inhibitor (PPI) controlled gastro-esophageal reflux disease (GERD). This study evaluated the safety and efficacy of ARMA over 12 months.</p><p><strong>Methods: </strong>This single-center prospective study included PPI-dependent GERD patients (acid exposure time [AET] > 6% or AET > 4.2% with reflux episodes > 80 on 24-h-pH-impedance monitoring). ARMA was performed in a standardized fashion using hybrid technique (sub-mucosal lift followed by ablation). Patients were evaluated using the GERD health-related quality of life questionnaire (HRQL) at baseline, three months and 12 months, with 24-h-pH-impedance monitoring at baseline and 12 months.</p><p><strong>Results: </strong>Total 216 patients (67.1% males, mean age = 38.7 years) underwent ARMA. At baseline, 123 (56.9%) patients had Hill's grade I and 93 (43.1%) had Hill's grade II on endoscopy. Ninety (41.7%) patients had Los Angeles (LA) grade A and 2 (0.93%) had LA grade B. There was a significant improvement in GERD-HRQL score from 43.8 (12.6) at baseline to 20.6 (13.8) at three months and to 8.3 (12.3) at 12 months (p = 0.001). The mean (SD) heartburn and regurgitation scores improved from 22.9 (10.8) and 20.6 (9.4) at baseline to 11.1 (8.7) and 9.5 (8.7) at three months and 3.9 (6.9) and 3.9 (6.9) at 12 months, respectively (p = 0.001). The AET (median [IQR]) decreased from 11.9 (15.9) to 7.6 (10.8) (n = 125, p = 0.009) at 12 months and the median DeMeester score reduced from 42.4 (47.1) to 26.2 (32.3) (p = 0.001). There was also a significant decrease in number of patients with AET 4% to 6% and > 6% and reflux episodes 40-80 and > 80 and DeMeester score > 14.72, as well as an increase in patients with AET < 4% and reflux episodes < 40. There was a significant improvement in Hill's grading and endoscopic esophagitis at one year. No major adverse events were observed.</p><p><strong>Conclusion: </strong>In PPI-dependent GERD patients, ARMA resulted in sustained symptom reduction and improved quality of life at 12 months. This procedure is relatively simple, widely accessible and has a good safety profile.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov (NCT04243668).</p>","PeriodicalId":13404,"journal":{"name":"Indian Journal of Gastroenterology","volume":" ","pages":"700-707"},"PeriodicalIF":2.1,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144266078","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-01Epub Date: 2025-07-04DOI: 10.1007/s12664-025-01808-1
Manjeet Kumar Goyal, Omesh Goyal, Ajit Sood
Evolution of the diagnostic criteria for functional gastrointestinal disorders (FGID) from Rome I to Rome IV in the past three decades represents a transformative shift from simplistic, symptom-based definitions to a nuanced framework that reflects the complex interplay between the gut and brain. Initial iterations, i.e. Rome-I and II criteria, established a standardized model that focused on clusters of symptoms rather than structural abnormalities, while Rome-III criteria introduced stricter symptom duration thresholds and acknowledged the influence of psychological factors. The introduction of Rome IV criteria in 2016 marked a watershed moment. FGIDs were renamed as 'disorders of gut-brain interaction' (DGBI), integrating advances in neurogastroenterology and emphasizing the pathophysiological roles of central neural processes, altered motility, immune regulation, dysbiosis, etc. These criteria redefined the diagnostic thresholds and emphasized on 'bothersome' symptoms that affect daily activities. For diagnosis of irritable bowel syndrome, abdominal pain, rather than discomfort, was essentially required and the sub-types of functional dyspepsia were more precisely defined. The Multidimensional Clinical Profile framework was added, which incorporated the sub-type, severity and psychological and physiological modifiers of DGBIs. However, the application of the Rome-IV criteria in the past eight years in clinical and research settings has faced a number of challenges, including the risk of underdiagnosing patients with milder symptoms, under-recognition of the overlaps of DGBIs and the lack of universal applicability due to socio-cultural and economic disparities in different geographical regions, Additionally, the new term, 'DGBI', while scientifically correct, can be discerned as potentially over-simplified and can itself be stigmatizing for patients who may inadvertently perceive these disorders as being primarily 'neuro-psychological'. The selective retention of the term 'functional' to name individual disorders such as functional dyspepsia and functional diarrhea remains to be justified. Advancements in neurogastroenterology research in the past decade have highlighted the significant prevalence of organic mimickers of DGBIs, most common being small intestinal bacterial overgrowth and non-celiac gluten sensitivity, which need to be ruled out, especially in 'refractory' DGBI cases. Substantial data on post-infectious DGBIs, especially post-COVID DGBIs, have been published. Importantly, multiple objective biomarkers have been proposed, which may complement and strengthen the symptom-based diagnostic criteria for DGBIs. By addressing the challenges, incorporating recent scientific advances and striking a balance between clinical practicality and global applicability, the future iterations of the Rome criteria have the potential to set new standards for the diagnosis and treatment of DGBIs.
{"title":"The road to Rome IV and beyond: Evolution, refinements and future considerations for the Rome criteria for functional gastrointestinal disorders.","authors":"Manjeet Kumar Goyal, Omesh Goyal, Ajit Sood","doi":"10.1007/s12664-025-01808-1","DOIUrl":"10.1007/s12664-025-01808-1","url":null,"abstract":"<p><p>Evolution of the diagnostic criteria for functional gastrointestinal disorders (FGID) from Rome I to Rome IV in the past three decades represents a transformative shift from simplistic, symptom-based definitions to a nuanced framework that reflects the complex interplay between the gut and brain. Initial iterations, i.e. Rome-I and II criteria, established a standardized model that focused on clusters of symptoms rather than structural abnormalities, while Rome-III criteria introduced stricter symptom duration thresholds and acknowledged the influence of psychological factors. The introduction of Rome IV criteria in 2016 marked a watershed moment. FGIDs were renamed as 'disorders of gut-brain interaction' (DGBI), integrating advances in neurogastroenterology and emphasizing the pathophysiological roles of central neural processes, altered motility, immune regulation, dysbiosis, etc. These criteria redefined the diagnostic thresholds and emphasized on 'bothersome' symptoms that affect daily activities. For diagnosis of irritable bowel syndrome, abdominal pain, rather than discomfort, was essentially required and the sub-types of functional dyspepsia were more precisely defined. The Multidimensional Clinical Profile framework was added, which incorporated the sub-type, severity and psychological and physiological modifiers of DGBIs. However, the application of the Rome-IV criteria in the past eight years in clinical and research settings has faced a number of challenges, including the risk of underdiagnosing patients with milder symptoms, under-recognition of the overlaps of DGBIs and the lack of universal applicability due to socio-cultural and economic disparities in different geographical regions, Additionally, the new term, 'DGBI', while scientifically correct, can be discerned as potentially over-simplified and can itself be stigmatizing for patients who may inadvertently perceive these disorders as being primarily 'neuro-psychological'. The selective retention of the term 'functional' to name individual disorders such as functional dyspepsia and functional diarrhea remains to be justified. Advancements in neurogastroenterology research in the past decade have highlighted the significant prevalence of organic mimickers of DGBIs, most common being small intestinal bacterial overgrowth and non-celiac gluten sensitivity, which need to be ruled out, especially in 'refractory' DGBI cases. Substantial data on post-infectious DGBIs, especially post-COVID DGBIs, have been published. Importantly, multiple objective biomarkers have been proposed, which may complement and strengthen the symptom-based diagnostic criteria for DGBIs. By addressing the challenges, incorporating recent scientific advances and striking a balance between clinical practicality and global applicability, the future iterations of the Rome criteria have the potential to set new standards for the diagnosis and treatment of DGBIs.</p>","PeriodicalId":13404,"journal":{"name":"Indian Journal of Gastroenterology","volume":" ","pages":"605-617"},"PeriodicalIF":2.1,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144560040","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-01Epub Date: 2025-06-13DOI: 10.1007/s12664-025-01788-2
Erfan Arabpour, Amir Sadeghi, Sajad Shojaee, Negin Tabatabaie, Sina Khoshdel, Amirreza Pouladi, Mohammad Abdehagh, Mohammad Reza Zali
Background and objectives: Endoscopic retrograde cholangiopancreatography (ERCP)-related perforations (EPs) are rare but serious adverse events, with a reported frequency of 0.4% to 0.6% and mortality rates reaching 8%. The lack of a uniform classification system for injury patterns and evidence-based management guidelines poses significant challenges in clinical decision-making. This systematic review evaluates therapeutic approaches and outcomes of EPs using the Stapfer classification to address these gaps.
Methods: We conducted a systematic review of studies that utilized the Stapfer classification to categorize EPs into four types, ranked by severity: type I (lateral/medial duodenal wall perforation), type II (periampullary injuries), type III (bile duct injuries) and type IV (retroperitoneal air alone). The study protocol was registered in PROSPERO (ID CRD42023473841).
Results: Among 287 patients from 18 eligible studies, type-I perforations were associated with significantly higher mortality (adjusted OR = 3.17, 95% CI 1.45-6.99). Surgical management did not significantly increase mortality risk compared to non-operative treatment (adjusted OR = 1.99, 95% CI 0.66-6.00) but was linked to prolonged hospital stays (coefficient 8.58, 95% CI 2.71-14.46). In contrast, perforation type did not significantly influence hospitalization duration (coefficient - 0.64, 95% CI - 4.04 to 2.76).
Conclusions: Our findings underscore the need for individualized treatment strategies based on perforation type and patient-specific factors. While the Stapfer classification aids in risk stratification, the heterogeneity of current evidence limits generalizability. Large-scale prospective studies are essential to establish standardized management protocols.
背景与目的:内镜逆行胆管造影(ERCP)相关穿孔(EPs)是罕见但严重的不良事件,报道频率为0.4%至0.6%,死亡率达8%。缺乏损伤模式的统一分类系统和循证管理指南对临床决策提出了重大挑战。本系统综述使用Stapfer分类来评估EPs的治疗方法和结果,以解决这些差距。方法:我们对采用Stapfer分类法将EPs按严重程度分为四种类型的研究进行了系统回顾:I型(十二指肠壁外侧/内侧穿孔),II型(腹腹部周围损伤),III型(胆管损伤)和IV型(腹膜后空气单独)。研究方案已在PROSPERO注册(ID CRD42023473841)。结果:在18项符合条件的研究的287例患者中,i型穿孔与显著较高的死亡率相关(校正OR = 3.17, 95% CI 1.45-6.99)。与非手术治疗相比,手术治疗没有显著增加死亡风险(调整后OR = 1.99, 95% CI 0.66-6.00),但与住院时间延长有关(系数8.58,95% CI 2.71-14.46)。相比之下,穿孔类型对住院时间无显著影响(系数- 0.64,95% CI - 4.04 ~ 2.76)。结论:我们的研究结果强调了基于穿孔类型和患者特异性因素的个性化治疗策略的必要性。虽然斯塔弗分类有助于风险分层,但目前证据的异质性限制了普遍性。大规模的前瞻性研究对于建立标准化的管理方案至关重要。
{"title":"Endoscopic retrograde cholangiopancreatography-related duodenal perforations: A systematic review and meta-analysis of management and outcomes.","authors":"Erfan Arabpour, Amir Sadeghi, Sajad Shojaee, Negin Tabatabaie, Sina Khoshdel, Amirreza Pouladi, Mohammad Abdehagh, Mohammad Reza Zali","doi":"10.1007/s12664-025-01788-2","DOIUrl":"10.1007/s12664-025-01788-2","url":null,"abstract":"<p><strong>Background and objectives: </strong>Endoscopic retrograde cholangiopancreatography (ERCP)-related perforations (EPs) are rare but serious adverse events, with a reported frequency of 0.4% to 0.6% and mortality rates reaching 8%. The lack of a uniform classification system for injury patterns and evidence-based management guidelines poses significant challenges in clinical decision-making. This systematic review evaluates therapeutic approaches and outcomes of EPs using the Stapfer classification to address these gaps.</p><p><strong>Methods: </strong>We conducted a systematic review of studies that utilized the Stapfer classification to categorize EPs into four types, ranked by severity: type I (lateral/medial duodenal wall perforation), type II (periampullary injuries), type III (bile duct injuries) and type IV (retroperitoneal air alone). The study protocol was registered in PROSPERO (ID CRD42023473841).</p><p><strong>Results: </strong>Among 287 patients from 18 eligible studies, type-I perforations were associated with significantly higher mortality (adjusted OR = 3.17, 95% CI 1.45-6.99). Surgical management did not significantly increase mortality risk compared to non-operative treatment (adjusted OR = 1.99, 95% CI 0.66-6.00) but was linked to prolonged hospital stays (coefficient 8.58, 95% CI 2.71-14.46). In contrast, perforation type did not significantly influence hospitalization duration (coefficient - 0.64, 95% CI - 4.04 to 2.76).</p><p><strong>Conclusions: </strong>Our findings underscore the need for individualized treatment strategies based on perforation type and patient-specific factors. While the Stapfer classification aids in risk stratification, the heterogeneity of current evidence limits generalizability. Large-scale prospective studies are essential to establish standardized management protocols.</p>","PeriodicalId":13404,"journal":{"name":"Indian Journal of Gastroenterology","volume":" ","pages":"634-645"},"PeriodicalIF":2.1,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144283798","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-01Epub Date: 2025-02-18DOI: 10.1007/s12664-025-01737-z
M Unnisa, A Agarwal, C Peddapulla, V Sharma, S Midha, S Jagannath, R Talukdar, A E Phillips, M Faghih, J Windsor, S S Olesen, P Garg, A M Drewes, L Kuhlmann
Background and objectives: Chronic pancreatitis (CP) is a fibroinflammatory disease causing functional injury. Abdominal pain is the predominant symptom negatively impacting the quality of life. The Comprehensive Pain Assessment Tool (COMPAT-SF) questionnaire, designed and validated to assess pain in CP, was previously only available in English and Danish. Given the high prevalence of CP in India, translating and validating COMPAT-SF into different languages becomes crucial.
Methods: The COMPAT-SF underwent translation into three Indian languages (Hindi, Telugu and Bengali) and was back-translated to English to ensure cross-cultural equivalence. Validation was conducted at two tertiary care centers in India. As Hindi is the most widespread language, bilingual CP patients answered the COMPAT-SF in Hindi and English at a three-week interval. All sub-group answers were compared with patient data from the US. Structural equation modeling and confirmatory factor analysis were employed for validation.
Results: Total 64 patients (19 Hindi-speaking,15 Telugu and 30 Bengali) were included and compared with 91 English-speaking patients. Translation adequacy was confirmed with > 85% concordance. Despite modest Cronbach alpha values in reliability analysis, structural equation modeling demonstrated high consistency with the original COMPAT-SF study. Some cultural differences in responses were observed, but the responses were comparable overall. Confirmatory factor analysis on the pooled data indicated an acceptable model fit and the Hindi version showed good accordance with the English version.
Conclusion: The translated COMPAT-SF versions proved to be valid and reliable pain assessment tools for CP patients. The study underscores the importance of addressing pain comprehensively.
{"title":"A cross-cultural study translating and validating the COMPAT-SF pain questionnaire in Telugu, Bengali and Hindi.","authors":"M Unnisa, A Agarwal, C Peddapulla, V Sharma, S Midha, S Jagannath, R Talukdar, A E Phillips, M Faghih, J Windsor, S S Olesen, P Garg, A M Drewes, L Kuhlmann","doi":"10.1007/s12664-025-01737-z","DOIUrl":"10.1007/s12664-025-01737-z","url":null,"abstract":"<p><strong>Background and objectives: </strong>Chronic pancreatitis (CP) is a fibroinflammatory disease causing functional injury. Abdominal pain is the predominant symptom negatively impacting the quality of life. The Comprehensive Pain Assessment Tool (COMPAT-SF) questionnaire, designed and validated to assess pain in CP, was previously only available in English and Danish. Given the high prevalence of CP in India, translating and validating COMPAT-SF into different languages becomes crucial.</p><p><strong>Methods: </strong>The COMPAT-SF underwent translation into three Indian languages (Hindi, Telugu and Bengali) and was back-translated to English to ensure cross-cultural equivalence. Validation was conducted at two tertiary care centers in India. As Hindi is the most widespread language, bilingual CP patients answered the COMPAT-SF in Hindi and English at a three-week interval. All sub-group answers were compared with patient data from the US. Structural equation modeling and confirmatory factor analysis were employed for validation.</p><p><strong>Results: </strong>Total 64 patients (19 Hindi-speaking,15 Telugu and 30 Bengali) were included and compared with 91 English-speaking patients. Translation adequacy was confirmed with > 85% concordance. Despite modest Cronbach alpha values in reliability analysis, structural equation modeling demonstrated high consistency with the original COMPAT-SF study. Some cultural differences in responses were observed, but the responses were comparable overall. Confirmatory factor analysis on the pooled data indicated an acceptable model fit and the Hindi version showed good accordance with the English version.</p><p><strong>Conclusion: </strong>The translated COMPAT-SF versions proved to be valid and reliable pain assessment tools for CP patients. The study underscores the importance of addressing pain comprehensively.</p>","PeriodicalId":13404,"journal":{"name":"Indian Journal of Gastroenterology","volume":" ","pages":"684-691"},"PeriodicalIF":2.1,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12417265/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143448931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The Indian Society of Gastroenterology has developed an evidence-based practice guideline for the management of caustic ingestion-related gastrointestinal (GI) injuries. A modified Delphi process was used to arrive at this consensus containing 41 statements. These statements were generated after two rounds of electronic voting, one round of physical meeting, and extensive review of the available literature. The exact prevalence of caustic injury and ingestion in developing countries is not known, though it appears to be of significant magnitude to pose a public health problem. The extent and severity of this preventable injury to the GI tract determine the short and long-term outcomes. Esophagogastroduodenoscopy is the preferred initial approach for the evaluation of injury and contrast-enhanced computed tomography is reserved only for specific situations. Low-grade injuries (Zargar grade ≤ 2a) have shown better outcomes with early oral feeding and discharge from hospital. However, patients with high-grade injury (Zargar grade ≥ 2b) require hospitalization as they are at a higher risk for both short and long-term complications, including luminal narrowing. These strictures can be managed endoscopically or surgically depending on the anatomy and extent of stricture, expertise available and patients' preferences. Nutritional support all along is crucial for all these patients until nutritional autonomy is established.
{"title":"Short-term and long-term management of caustic-induced gastrointestinal injury: An evidence-based practice guidelines.","authors":"Anupam Kumar Singh, Deepak Gunjan, Nihar Ranjan Dash, Ujjal Poddar, Pankaj Gupta, Ajay Kumar Jain, Deepak Lahoti, Jamshed Nayer, Mahesh Goenka, Mathew Philip, Rakesh Chadda, Rajneesh Kumar Singh, Sreekanth Appasani, Showkat Ali Zargar, Sohan Lal Broor, Sandeep Nijhawan, Siddharth Shukla, Vikas Gupta, Vikram Kate, Govind Makharia, Rakesh Kochhar","doi":"10.1007/s12664-024-01692-1","DOIUrl":"10.1007/s12664-024-01692-1","url":null,"abstract":"<p><p>The Indian Society of Gastroenterology has developed an evidence-based practice guideline for the management of caustic ingestion-related gastrointestinal (GI) injuries. A modified Delphi process was used to arrive at this consensus containing 41 statements. These statements were generated after two rounds of electronic voting, one round of physical meeting, and extensive review of the available literature. The exact prevalence of caustic injury and ingestion in developing countries is not known, though it appears to be of significant magnitude to pose a public health problem. The extent and severity of this preventable injury to the GI tract determine the short and long-term outcomes. Esophagogastroduodenoscopy is the preferred initial approach for the evaluation of injury and contrast-enhanced computed tomography is reserved only for specific situations. Low-grade injuries (Zargar grade ≤ 2a) have shown better outcomes with early oral feeding and discharge from hospital. However, patients with high-grade injury (Zargar grade ≥ 2b) require hospitalization as they are at a higher risk for both short and long-term complications, including luminal narrowing. These strictures can be managed endoscopically or surgically depending on the anatomy and extent of stricture, expertise available and patients' preferences. Nutritional support all along is crucial for all these patients until nutritional autonomy is established.</p>","PeriodicalId":13404,"journal":{"name":"Indian Journal of Gastroenterology","volume":" ","pages":"646-674"},"PeriodicalIF":2.1,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143467135","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}