Pub Date : 2026-01-02DOI: 10.1016/j.dld.2025.12.006
Cong Xie , Jingyu Wang , Yushan Meng , Yining Huang , Hang Zhang , Bin Cao
Background
Clinical practice currently lacks objective and accurate screening tools for minimal hepatic encephalopathy (MHE). Therefore, we aimed to develop an MHE prediction model based on common risk factors.
Methods
A total of 514 and 191 cirrhotic patients were included in the training and external validation cohorts, respectively. Best subset selection was applied to screen for predictors. Logistic regression was selected for model development because it outperformed four machine learning algorithms (Random Forest, Adaptive Boosting, Support Vector Machines, and Naive Bayes) in this study. Discrimination, calibration, and clinical decision-making utility of the model were evaluated. Furthermore, the model was compared with the Stroop test for MHE assessment.
Results
From 44 potential predictors, 6 variables were identified as significant and included in the prediction model: upper gastrointestinal bleeding (odds ratio, 4.17; 95% confidence interval, 2.53–6.88), ascites (2.86; 1.59–5.16), albumin (0.76; 0.70–0.82), ammonia-ULN-ratio (5.89; 3.43–10.13), model for end-stage liver disease (1.16; 1.08–1.26), and long-term oral lactulose (0.04; 0.01–0.11). The model exhibited robustness and outperformed the Stroop test for MHE identification, with areas under the receiver operating characteristic curves of 0.882 and 0.867 for the training and validation datasets, respectively. An interactive web-based nomogram is accessible at https://xc-web.shinyapps.io/dynnomapp/.
{"title":"Construction and validation of a screening model for minimal hepatic encephalopathy in patients with cirrhosis: A multi-center study","authors":"Cong Xie , Jingyu Wang , Yushan Meng , Yining Huang , Hang Zhang , Bin Cao","doi":"10.1016/j.dld.2025.12.006","DOIUrl":"10.1016/j.dld.2025.12.006","url":null,"abstract":"<div><h3>Background</h3><div>Clinical practice currently lacks objective and accurate screening tools for minimal hepatic encephalopathy (MHE). Therefore, we aimed to develop an MHE prediction model based on common risk factors.</div></div><div><h3>Methods</h3><div>A total of 514 and 191 cirrhotic patients were included in the training and external validation cohorts, respectively. Best subset selection was applied to screen for predictors. Logistic regression was selected for model development because it outperformed four machine learning algorithms (Random Forest, Adaptive Boosting, Support Vector Machines, and Naive Bayes) in this study. Discrimination, calibration, and clinical decision-making utility of the model were evaluated. Furthermore, the model was compared with the Stroop test for MHE assessment.</div></div><div><h3>Results</h3><div>From 44 potential predictors, 6 variables were identified as significant and included in the prediction model: upper gastrointestinal bleeding (odds ratio, 4.17; 95% confidence interval, 2.53–6.88), ascites (2.86; 1.59–5.16), albumin (0.76; 0.70–0.82), ammonia-ULN-ratio (5.89; 3.43–10.13), model for end-stage liver disease (1.16; 1.08–1.26), and long-term oral lactulose (0.04; 0.01–0.11). The model exhibited robustness and outperformed the Stroop test for MHE identification, with areas under the receiver operating characteristic curves of 0.882 and 0.867 for the training and validation datasets, respectively. An interactive web-based nomogram is accessible at <span><span>https://xc-web.shinyapps.io/dynnomapp/</span><svg><path></path></svg></span>.</div></div><div><h3>Conclusions</h3><div>This model enables rapid MHE screening.</div></div>","PeriodicalId":11268,"journal":{"name":"Digestive and Liver Disease","volume":"58 2","pages":"Pages 232-240"},"PeriodicalIF":3.8,"publicationDate":"2026-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145896376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A case of colorectal malakoplakia in a patient with cytomegalovirus-associated refractory ulcerative colitis","authors":"Shinichiro Kawatoko , Hidetaka Yamamoto , Yuta Fuyuno , Junji Umeno","doi":"10.1016/j.dld.2025.08.086","DOIUrl":"10.1016/j.dld.2025.08.086","url":null,"abstract":"","PeriodicalId":11268,"journal":{"name":"Digestive and Liver Disease","volume":"58 1","pages":"Pages 131-132"},"PeriodicalIF":3.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145063756","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Screening strategies for anal cancer are based on repeated assessments in targeted populations. Low-grade lesions are frequently diagnosed, but the progression to invasive cancer is not the rule. The aim of the present study was to identify risk levels in these patients to refine screening strategies.
Methods
The data of consecutive patients referred for screening of anal intraepithelial lesions were collected prospectively. Patients with low-grade intraepithelial lesions (LSILs) at referral and at least two clinical evaluations, including cytology and virology, were included. HPV DNA screening, high-grade lesion (HSIL) and invasive cancer incidence data were extracted.
Results
From April 2010 to December 2020, 194 patients with LSILs were included, with a median follow-up of 48 months. The cumulative probabilities of HSILs were 13.7% [9.5–19.4] at 1 year and 44.4% [35.9–53.3] at 5 years. Past history of HIV, HPV lesions, HPV subtypes (except HPV16), tobacco consumption and body mass index were not significantly related to HSILs. HPV16 status and age older than 44 years at baseline were associated with a greater risk of HSIL.
Conclusions
Patients with LSIL have a low risk of HSILs, except those with HPV16 subtype at baseline. After a first-year a reasonable recommendation may be a 4-year interval between two screening visits.
{"title":"Anal neoplasm: Streamline follow-up of low-grade dysplasia","authors":"Aurore Carlo , Laurent Siproudhis , Amandine Landemaine , Claire Gouriou , Claire Grolhier , Astrid Lièvre , Sébastien Henno , Charlène Brochard","doi":"10.1016/j.dld.2025.09.013","DOIUrl":"10.1016/j.dld.2025.09.013","url":null,"abstract":"<div><h3>Background</h3><div>Screening strategies for anal cancer are based on repeated assessments in targeted populations. Low-grade lesions are frequently diagnosed, but the progression to invasive cancer is not the rule. The aim of the present study was to identify risk levels in these patients to refine screening strategies.</div></div><div><h3>Methods</h3><div>The data of consecutive patients referred for screening of anal intraepithelial lesions were collected prospectively. Patients with low-grade intraepithelial lesions (LSILs) at referral and at least two clinical evaluations, including cytology and virology, were included. HPV DNA screening, high-grade lesion (HSIL) and invasive cancer incidence data were extracted.</div></div><div><h3>Results</h3><div>From April 2010 to December 2020, 194 patients with LSILs were included, with a median follow-up of 48 months. The cumulative probabilities of HSILs were 13.7% [9.5–19.4] at 1 year and 44.4% [35.9–53.3] at 5 years. Past history of HIV, HPV lesions, HPV subtypes (except HPV16), tobacco consumption and body mass index were not significantly related to HSILs. HPV16 status and age older than 44 years at baseline were associated with a greater risk of HSIL.</div></div><div><h3>Conclusions</h3><div>Patients with LSIL have a low risk of HSILs, except those with HPV16 subtype at baseline. After a first-year a reasonable recommendation may be a 4-year interval between two screening visits.</div></div>","PeriodicalId":11268,"journal":{"name":"Digestive and Liver Disease","volume":"58 1","pages":"Pages 125-130"},"PeriodicalIF":3.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.dld.2025.09.018
Alberto Zanetto , Dario Saltini , Elena Campello , Cristiana Bulato , Sabrina Gavasso , Patrizia Burra , Paolo Simioni , Marco Senzolo
Background
Hemostasis may be involved in cirrhosis progression. However, its potential involvement in hepatic recompensation is unknown.
Objective
We investigated predictors of recompensation, including coagulation and fibrinolysis, in acutely decompensated, alcohol-related cirrhosis.
Methods
Clinical and laboratory data were collected at hospitalization. Coagulation was assessed via factor VIII, natural anticoagulants, and thrombin generation assay. Fibrinolysis was assessed via pro and anti-fibrinolytic factors and plasmin-antiplasmin complexes. Patients were prospectively followed up for recompensation according to Baveno VII criteria.
Results
We included 224 patients (Child-Pugh B/C 46/54 %). Cumulative rate of recompensation was 5.4 % (median follow-up: 450 days). Patients who achieved recompensation had lower MELD (12 vs. 17, p = 0.02), Child-Pugh C (25 % vs 56 %, p = 0.04), and higher platelet count (106 × 109/L vs. 83 × 109/L) than those who did not, without differences in coagulation and fibrinolysis. In Cox-regression analysis, Child-Pugh was the only predictor of recompensation (HR: 0.26; p = 0.02). Same results were observed with the “expanded” Baveno VII criteria for recompensation. A competing risk analysis considering ACLF/liver-related death, transplantation, and TIPS as competing risks showed comparable results.
Conclusion
In acutely decompensated, alcohol-related cirrhosis, recompensation is rare and linked to the baseline severity of liver disease. Coagulation and fibrinolysis seem not to be involved in cirrhosis recompensation.
{"title":"Recompensation after acute decompensation in alcohol-related cirrhosis is rare and likely unrelated to platelet-poor plasma thrombin generation and fibrinolysis","authors":"Alberto Zanetto , Dario Saltini , Elena Campello , Cristiana Bulato , Sabrina Gavasso , Patrizia Burra , Paolo Simioni , Marco Senzolo","doi":"10.1016/j.dld.2025.09.018","DOIUrl":"10.1016/j.dld.2025.09.018","url":null,"abstract":"<div><h3>Background</h3><div>Hemostasis may be involved in cirrhosis progression. However, its potential involvement in hepatic recompensation is unknown.</div></div><div><h3>Objective</h3><div>We investigated predictors of recompensation, including coagulation and fibrinolysis, in acutely decompensated, alcohol-related cirrhosis.</div></div><div><h3>Methods</h3><div>Clinical and laboratory data were collected at hospitalization. Coagulation was assessed via factor VIII, natural anticoagulants, and thrombin generation assay. Fibrinolysis was assessed via pro and anti-fibrinolytic factors and plasmin-antiplasmin complexes. Patients were prospectively followed up for recompensation according to Baveno VII criteria.</div></div><div><h3>Results</h3><div>We included 224 patients (Child-Pugh B/C 46/54 %). Cumulative rate of recompensation was 5.4 % (median follow-up: 450 days). Patients who achieved recompensation had lower MELD (12 vs. 17, <em>p</em> = 0.02), Child-Pugh C (25 % vs 56 %, <em>p</em> = 0.04), and higher platelet count (106 × 10<sup>9</sup>/L vs. 83 × 10<sup>9</sup>/L) than those who did not, without differences in coagulation and fibrinolysis. In Cox-regression analysis, Child-Pugh was the only predictor of recompensation (HR: 0.26; <em>p</em> = 0.02). Same results were observed with the “expanded” Baveno VII criteria for recompensation. A competing risk analysis considering ACLF/liver-related death, transplantation, and TIPS as competing risks showed comparable results.</div></div><div><h3>Conclusion</h3><div>In acutely decompensated, alcohol-related cirrhosis, recompensation is rare and linked to the baseline severity of liver disease. Coagulation and fibrinolysis seem not to be involved in cirrhosis recompensation.</div></div>","PeriodicalId":11268,"journal":{"name":"Digestive and Liver Disease","volume":"58 1","pages":"Pages 88-95"},"PeriodicalIF":3.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145228515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.dld.2025.10.033
Jiu Chen , Peng Gong , Jun Xie
{"title":"Author's reply: Comment on “Effects of exercise on body composition, fitness, and blood pressure in overweight or obese patients with MASLD”","authors":"Jiu Chen , Peng Gong , Jun Xie","doi":"10.1016/j.dld.2025.10.033","DOIUrl":"10.1016/j.dld.2025.10.033","url":null,"abstract":"","PeriodicalId":11268,"journal":{"name":"Digestive and Liver Disease","volume":"58 1","pages":"Pages 145-146"},"PeriodicalIF":3.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145530492","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
We performed a randomized, double-blind, placebo-controlled, trial to investigate the changes in microbiome composition induced by Butyrate-Lsc-Microincapsulated (BLM) supplementation in IBD patients and its impact on disease activity.
Methods
140 IBD patients (n=60 Crohn's disease, CD and n=80 Ulcerative Colitis, UC) were randomized to oral administration of BLM, plus conventional therapy. Stool samples were assessed by 16S sequencing and fecal calprotectin (fCal) analysis. For the microbiota analysis, the Firmicutes/Bacteroidota (F/B) ratio was used. Clinical disease activity was assessed by using the Harvey-Bradshaw-Index (HBI) for CD and partial-Mayo-Score for UC, Quality-of-life (QoL) by using Inflammatory-Bowel-Disease-Questionnaire-32 (IBDQ) and adherence-dietary-recommendation was evaluated before and after supplementation
Results
microbiota analysis revealed two principal enterotypes, defined by the F/B ratio, in both CD and UC patients. BLM exerted a more pronounced effect on Enterotype 1 (low F/B ratio), resulting in greater clinical and biochemical improvements and potentially identifying a target population. After supplementation, clinical disease activity (p=0.013) and fCal (p=0.047) improved significantly in CD, while fCal showed a marginal reduction in UC (p=0.09). QoL increased significantly in both CD (p<0.001) and UC (p=0.003).
Conclusions
Supplementation with BLM, by modulating the gut microbiota, significantly improved disease outcomes and QoL in patients with IBD.
{"title":"Impact of oral butyrate on clinical and biochemical parameters in IBD: A randomized placebo-controlled study targeting gut microbiota","authors":"Sonia Facchin , Matteo Calgaro , Mattia Pandolfo , Andrea Buda , Brigida Barberio , Fabiana Zingone , Nicola Vitulo , Edoardo Vincenzo Savarino","doi":"10.1016/j.dld.2025.11.014","DOIUrl":"10.1016/j.dld.2025.11.014","url":null,"abstract":"<div><h3>Background and Aims</h3><div>We performed a randomized, double-blind, placebo-controlled, trial to investigate the changes in microbiome composition induced by Butyrate-Lsc-Microincapsulated (BLM) supplementation in IBD patients and its impact on disease activity.</div></div><div><h3>Methods</h3><div>140 IBD patients (n=60 Crohn's disease, CD and n=80 Ulcerative Colitis, UC) were randomized to oral administration of BLM, plus conventional therapy. Stool samples were assessed by 16S sequencing and fecal calprotectin (fCal) analysis. For the microbiota analysis, the Firmicutes/Bacteroidota (F/B) ratio was used. Clinical disease activity was assessed by using the Harvey-Bradshaw-Index (HBI) for CD and partial-Mayo-Score for UC, Quality-of-life (QoL) by using Inflammatory-Bowel-Disease-Questionnaire-32 (IBDQ) and adherence-dietary-recommendation was evaluated before and after supplementation</div></div><div><h3>Results</h3><div>microbiota analysis revealed two principal enterotypes, defined by the F/B ratio, in both CD and UC patients. BLM exerted a more pronounced effect on Enterotype 1 (low F/B ratio), resulting in greater clinical and biochemical improvements and potentially identifying a target population. After supplementation, clinical disease activity (p=0.013) and fCal (p=0.047) improved significantly in CD, while fCal showed a marginal reduction in UC (p=0.09). QoL increased significantly in both CD (p<0.001) and UC (p=0.003).</div></div><div><h3>Conclusions</h3><div>Supplementation with BLM, by modulating the gut microbiota, significantly improved disease outcomes and QoL in patients with IBD.</div></div><div><h3>ClinicalTrial.gov registration</h3><div>NCT04879914</div></div>","PeriodicalId":11268,"journal":{"name":"Digestive and Liver Disease","volume":"58 1","pages":"Pages 64-73"},"PeriodicalIF":3.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145699718","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.dld.2025.10.013
Fabienne Bender , Leon Marzeion , Juliane Liese , Matthias Hecker , Matthias Wolff , Theresa König , Franziska Willis , Ivan de la Peña Thevenet , Christopher Tuffs , Alexander Brose , Joern Pons-Kühnemann , Winfried Padberg , Andreas Hecker , Moritz J. Strowitzki
Background
Sarcopenia and age are risk factors for poor outcomes in acute pancreatitis (aP). However, the role of sarcopenia independent of patients’ age remains unclear, and assessment methods vary.
Aims
This study assessed sarcopenia, using the Hounsfield unit average calculation (HUAC) for the psoas muscle, and its impact on aP outcomes, independent of other risk factors.
Methods
208 aP patients who received early computed tomography (CT) were classified as sarcopenic or non-sarcopenic based on HUAC. Propensity score matching (PSM) reduced heterogeneity. Clinical outcomes and independent predictors of intensive care unit (ICU) admission were determined by multivariable logistic regression.
Results
After PSM, sarcopenic patients (n = 53) had longer hospital (24.9 ± 20.6d vs. 18.2 ± 27.3d; p = 0.0006) and ICU stays (9.5 ± 16.5d vs. 6.2 ± 25.8d; p = 0.0077) than non-sarcopenic patients (n = 53). ICU admission was more frequent (58.5 % vs. 37.7 %; p = 0.0325), and aP-associated morbidity such as pleural effusion occurred more often (p = 0.0019). Independent predictors of ICU admission included pleural effusion or ascites (p = 0.0116) and impaired coagulation (p = 0.0365).
Conclusion
Sarcopenia identified via HUAC in early aP is associated with a worse clinical outcome. Pleural effusion or ascites and changes in blood coagulation independently predict ICU admission in sarcopenic aP patients. Early nutritional and physical therapy should be considered to prevent and treat sarcopenia in aP patients.
背景：骨骼肌减少症和年龄是急性胰腺炎（aP）预后不良的危险因素。然而，肌少症独立于患者年龄的作用仍不清楚，评估方法也各不相同。目的：本研究评估肌肉减少症，使用腰大肌的Hounsfield单位平均计算（HUAC），及其对aP结果的影响，独立于其他危险因素。方法：208例早期行计算机断层扫描（CT）的aP患者，根据HUAC分为肌少症和非肌少症。倾向评分匹配（PSM）降低了异质性。采用多变量logistic回归确定重症监护病房（ICU）入院的临床结局和独立预测因素。结果：经PSM治疗后，肌少症患者（n = 53）的住院时间（24.9±20.6d比18.2±27.3d, p = 0.0006）和ICU住院时间（9.5±16.5d比6.2±25.8d, p = 0.0077）均高于非肌少症患者（n = 53）。ICU住院率更高（58.5%比37.7%,p = 0.0325）， ap相关并发症如胸腔积液发生率更高（p = 0.0019）。ICU入院的独立预测因素包括胸腔积液或腹水（p = 0.0116）和凝血功能受损（p = 0.0365）。结论：早期aP患者通过HUAC检测出的骨骼肌减少症与较差的临床预后相关。胸腔积液或腹水及凝血变化可独立预测肌减少性aP患者是否入住ICU。早期应考虑营养和物理治疗，以预防和治疗肌少症的aP患者。
{"title":"Sarcopenia is associated with an unfavorable outcome in patients with acute pancreatitis: A propensity score analysis","authors":"Fabienne Bender , Leon Marzeion , Juliane Liese , Matthias Hecker , Matthias Wolff , Theresa König , Franziska Willis , Ivan de la Peña Thevenet , Christopher Tuffs , Alexander Brose , Joern Pons-Kühnemann , Winfried Padberg , Andreas Hecker , Moritz J. Strowitzki","doi":"10.1016/j.dld.2025.10.013","DOIUrl":"10.1016/j.dld.2025.10.013","url":null,"abstract":"<div><h3>Background</h3><div>Sarcopenia and age are risk factors for poor outcomes in acute pancreatitis (aP). However, the role of sarcopenia independent of patients’ age remains unclear, and assessment methods vary.</div></div><div><h3>Aims</h3><div>This study assessed sarcopenia, using the Hounsfield unit average calculation (HUAC) for the psoas muscle, and its impact on aP outcomes, independent of other risk factors.</div></div><div><h3>Methods</h3><div>208 aP patients who received early computed tomography (CT) were classified as sarcopenic or non-sarcopenic based on HUAC. Propensity score matching (PSM) reduced heterogeneity. Clinical outcomes and independent predictors of intensive care unit (ICU) admission were determined by multivariable logistic regression.</div></div><div><h3>Results</h3><div>After PSM, sarcopenic patients (<em>n</em> = 53) had longer hospital (24.9 ± 20.6d vs. 18.2 ± 27.3d; <em>p</em> = 0.0006) and ICU stays (9.5 ± 16.5d vs. 6.2 ± 25.8d; <em>p</em> = 0.0077) than non-sarcopenic patients (<em>n</em> = 53). ICU admission was more frequent (58.5 % vs. 37.7 %; <em>p</em> = 0.0325), and aP-associated morbidity such as pleural effusion occurred more often (<em>p</em> = 0.0019). Independent predictors of ICU admission included pleural effusion or ascites (<em>p</em> = 0.0116) and impaired coagulation (<em>p</em> = 0.0365).</div></div><div><h3>Conclusion</h3><div>Sarcopenia identified via HUAC in early aP is associated with a worse clinical outcome. Pleural effusion or ascites and changes in blood coagulation independently predict ICU admission in sarcopenic aP patients. Early nutritional and physical therapy should be considered to prevent and treat sarcopenia in aP patients.</div></div>","PeriodicalId":11268,"journal":{"name":"Digestive and Liver Disease","volume":"58 1","pages":"Pages 96-103"},"PeriodicalIF":3.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145451343","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.dld.2025.10.032
Yoshihiro Kishida , Tadakazu Shimoda , Kinichi Hotta , Kenichiro Imai , Sayo Ito , Hiroyuki Ono
{"title":"Author’s reply: Comment on “Endoscopic features for differentiating sessile serrated lesion with dysplasia or carcinoma in serrated lesions ≥10 mm”","authors":"Yoshihiro Kishida , Tadakazu Shimoda , Kinichi Hotta , Kenichiro Imai , Sayo Ito , Hiroyuki Ono","doi":"10.1016/j.dld.2025.10.032","DOIUrl":"10.1016/j.dld.2025.10.032","url":null,"abstract":"","PeriodicalId":11268,"journal":{"name":"Digestive and Liver Disease","volume":"58 1","pages":"Page 139"},"PeriodicalIF":3.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145502754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.dld.2025.11.003
Jérémie H. Lefevre , Olivier Dubreuil , Raphael Colle , David Tougeron , Angélique Vienot , Aurélien Dupré , Clémence Toullec , Denis Smith , Rosine Guimbaud , Benoist Chibaudel , Marie-Line Garcia Larnicol , Dewi Vernerey , Romain Cohen , PREMICES Study Group
Background
Microsatellite instability (MSI) or mismatch‑repair deficiency (dMMR) defines a biologically distinct subgroup of colorectal cancers that are highly responsive to immune checkpoint inhibition. Major and complete pathological responses have been observed with neoadjuvant immunotherapy, raising the possibility of avoiding upfront surgery in selected patients.
Methods
PREMICES is a multicenter, open‑label, randomized (1:1), non‑comparative phase II trial evaluating neoadjuvant pembrolizumab followed by a structured watch‑and‑wait strategy versus standard-of-care surgery ± adjuvant chemotherapy in adults with resectable, localized MSI/dMMR colon or upper rectal adenocarcinoma. Sixty patients will be randomized across nine French centers. The primary endpoint is 6-month strategy success after randomization (or after two successive colonoscopies), defined as the absence of death, disease progression, a decision to operate due to residual tumor on biopsies, or any primary‑tumor surgery. Secondary endpoints include the 24-month success, event‑free and overall survival, postoperative morbidity, health‑related quality of life (EORTC QLQ‑C30/CR29), tumor regression, and endoscopic complete response. Embedded translational studies include circulating tumor DNA and gut microbiota analyses. Randomization started in September 2025.
Discussion
PREMICES will determine whether a neoadjuvant PD‑1 blockade‑based non‑operative approach can be pursued safely and effectively in localized MSI/dMMR colon cancer and will generate prospective patient‑centered outcomes and biomarker data to inform future phase III trials.
Trial registration
EU‑CT (CTIS) number: 2023‑509322‑22‑00. Registered prior to first patient enrolment.
{"title":"Neoadjuvant pembrolizumab with a watch‑and‑wait strategy for localized MSI/dMMR colon cancer: Study protocol for a randomized GERCOR 109 – PRODIGE 84 phase II trial (PREMICES)","authors":"Jérémie H. Lefevre , Olivier Dubreuil , Raphael Colle , David Tougeron , Angélique Vienot , Aurélien Dupré , Clémence Toullec , Denis Smith , Rosine Guimbaud , Benoist Chibaudel , Marie-Line Garcia Larnicol , Dewi Vernerey , Romain Cohen , PREMICES Study Group","doi":"10.1016/j.dld.2025.11.003","DOIUrl":"10.1016/j.dld.2025.11.003","url":null,"abstract":"<div><h3>Background</h3><div>Microsatellite instability (MSI) or mismatch‑repair deficiency (dMMR) defines a biologically distinct subgroup of colorectal cancers that are highly responsive to immune checkpoint inhibition. Major and complete pathological responses have been observed with neoadjuvant immunotherapy, raising the possibility of avoiding upfront surgery in selected patients.</div></div><div><h3>Methods</h3><div>PREMICES is a multicenter, open‑label, randomized (1:1), non‑comparative phase II trial evaluating neoadjuvant pembrolizumab followed by a structured watch‑and‑wait strategy versus standard-of-care surgery ± adjuvant chemotherapy in adults with resectable, localized MSI/dMMR colon or upper rectal adenocarcinoma. Sixty patients will be randomized across nine French centers. The primary endpoint is 6-month strategy success after randomization (or after two successive colonoscopies), defined as the absence of death, disease progression, a decision to operate due to residual tumor on biopsies, or any primary‑tumor surgery. Secondary endpoints include the 24-month success, event‑free and overall survival, postoperative morbidity, health‑related quality of life (EORTC QLQ‑C30/CR29), tumor regression, and endoscopic complete response. Embedded translational studies include circulating tumor DNA and gut microbiota analyses. Randomization started in September 2025.</div></div><div><h3>Discussion</h3><div>PREMICES will determine whether a neoadjuvant PD‑1 blockade‑based non‑operative approach can be pursued safely and effectively in localized MSI/dMMR colon cancer and will generate prospective patient‑centered outcomes and biomarker data to inform future phase III trials.</div></div><div><h3>Trial registration</h3><div>EU‑CT (CTIS) number: 2023‑509322‑22‑00. Registered prior to first patient enrolment.</div></div>","PeriodicalId":11268,"journal":{"name":"Digestive and Liver Disease","volume":"58 1","pages":"Pages 51-55"},"PeriodicalIF":3.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145586105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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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