Pub Date : 2026-02-07DOI: 10.1016/j.dld.2026.01.221
Lorenzo Ridola
{"title":"Clinical prediction models in minimal hepatic encephalopathy: how far can they go?","authors":"Lorenzo Ridola","doi":"10.1016/j.dld.2026.01.221","DOIUrl":"https://doi.org/10.1016/j.dld.2026.01.221","url":null,"abstract":"","PeriodicalId":11268,"journal":{"name":"Digestive and Liver Disease","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146141062","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 : 2026-02-07DOI: 10.1016/j.dld.2026.01.001
Yanqin Zhang, Liuhong Dai, Teng Ma
{"title":"Reconsidering the clinical implications of oral butyrate supplementation in inflammatory bowel disease.","authors":"Yanqin Zhang, Liuhong Dai, Teng Ma","doi":"10.1016/j.dld.2026.01.001","DOIUrl":"https://doi.org/10.1016/j.dld.2026.01.001","url":null,"abstract":"","PeriodicalId":11268,"journal":{"name":"Digestive and Liver Disease","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146141157","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}
Pyogenic granuloma (PG) or lobular capillary hemangioma (LCH) is a benign vascular tumor characterized by rapid growth, nodular hyperplasia, and bleeding propensity. Though common on skin/oral mucosa, esophageal occurrence is rare. We report a 34-year-old male with recurrent acid reflux. Upper endoscopy (July 2022) revealed a 10-mm polypoid lesion above the esophagogastric junction, absent 13 months prior. It was successfully resected via endoscopic mucosal resection (EMR) after submucosal saline injection, with histology confirming esophageal PG (LCH). Our literature review identified and analyzed 21 previous detailed cases. Analysis of 22 total cases shows these lesions predominantly affect Asian males (M:F=19:3; mean age 57.8 ± 14.8 years). Most patients (71.6%) were symptomatic, primarily with dysphagia or gastrointestinal bleeding. Nearly half (50.0%) occurred in the lower esophagus, averaging 11.5 ± 6.2 mm in size. Over 50% appeared as reddish, exudate-covered nodules, typically pedunculated or semi-pedunculated. EMR effectively managed most cases. This report highlights esophageal PG's potential for rapid growth and supports EMR's diagnostic/therapeutic efficacy, underscoring the importance of recognizing this rare entity for appropriate management.
{"title":"Rapidly growing esophageal pyogenic granuloma: A case report and review of the literature.","authors":"Xiaoxia Zhang, Jianjun Li, Xinwei Diao, Ying Huang, Qiujian Qiao, Jianying Bai, Xue Peng","doi":"10.1016/j.dld.2026.01.209","DOIUrl":"https://doi.org/10.1016/j.dld.2026.01.209","url":null,"abstract":"<p><p>Pyogenic granuloma (PG) or lobular capillary hemangioma (LCH) is a benign vascular tumor characterized by rapid growth, nodular hyperplasia, and bleeding propensity. Though common on skin/oral mucosa, esophageal occurrence is rare. We report a 34-year-old male with recurrent acid reflux. Upper endoscopy (July 2022) revealed a 10-mm polypoid lesion above the esophagogastric junction, absent 13 months prior. It was successfully resected via endoscopic mucosal resection (EMR) after submucosal saline injection, with histology confirming esophageal PG (LCH). Our literature review identified and analyzed 21 previous detailed cases. Analysis of 22 total cases shows these lesions predominantly affect Asian males (M:F=19:3; mean age 57.8 ± 14.8 years). Most patients (71.6%) were symptomatic, primarily with dysphagia or gastrointestinal bleeding. Nearly half (50.0%) occurred in the lower esophagus, averaging 11.5 ± 6.2 mm in size. Over 50% appeared as reddish, exudate-covered nodules, typically pedunculated or semi-pedunculated. EMR effectively managed most cases. This report highlights esophageal PG's potential for rapid growth and supports EMR's diagnostic/therapeutic efficacy, underscoring the importance of recognizing this rare entity for appropriate management.</p>","PeriodicalId":11268,"journal":{"name":"Digestive and Liver Disease","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146141031","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}
Background: Acute cholangitis (AC) is life-threatening, requiring urgent biliary drainage. Endoscopic biliary drainage (EBD), often combined with endoscopic sphincterotomy (EST), may prevent post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP). However, sepsis-induced coagulopathy (SIC) increases bleeding risk, raising concerns about EST safety.
Aims: To evaluate the risk of adverse events (AEs) and clinical outcomes associated with EBD with or without EST in patients with AC and SIC.
Methods: In this retrospective multicentre cohort study, data from enrolled patients were analysed using propensity score matching, and outcomes were compared between EST and non-EST groups. The primary endpoint was the AE rate difference between EBD with and without EST. Secondary endpoints included differences in clinical outcomes.
Results: Among 238 patients, 72 underwent EST and 166 did not. The AE incidence, particularly bleeding-related (11.1% vs. 0.6%, P<.001), was higher in the EST group (16.7% vs. 1.8%, P<.001) while PEP incidence (4.2% vs. 1.2%, P=.143) did not differ. Propensity score-matched analysis confirmed these findings. Clinical success or 28-day survival rates did not differ significantly.
Conclusion: EST significantly increases bleeding risk in patients with AC and SIC without reducing PEP incidence or improving clinical outcomes. EBD without EST can minimise bleeding risk while maintaining adequate biliary drainage.
{"title":"Sphincterotomy during endoscopic biliary drainage in cholangitis with sepsis-induced coagulopathy increases bleeding without clinical benefits.","authors":"Yasuhisa Hiroshima, Ryota Sagami, Naosuke Kuraoka, Tatsuya Noguchi, Yasusato Matsuda, Takero Terayama, Yoshifumi Azuma, Takao Sato, Hidefumi Nishikori, Hideho Honda, Yasuhiko Goto, Haruna Noguchi, Satoshi Fukuchi, Kaoru Omori, Mitsuteru Motomura, Tadayoshi Okimoto, Kazuhisa Okamoto, Hideki Mori, Tatsuya Sato, Kosuke Takahashi, Eisuke Ozawa, Eriko Ikeda, Atsushi Kanno, Shunsuke Komoto, Takehiko Koga, Yusuke Ishida, Kiyoyuki Kobayashi, Makoto Hinokuchi, Ryo Ihara, Takahiro Ueda, Nao Fujimori, Osamu Matsunari, Chishio Noguchi, Kazuhiro Mizukami, Kazunari Murakami","doi":"10.1016/j.dld.2026.01.218","DOIUrl":"https://doi.org/10.1016/j.dld.2026.01.218","url":null,"abstract":"<p><strong>Background: </strong>Acute cholangitis (AC) is life-threatening, requiring urgent biliary drainage. Endoscopic biliary drainage (EBD), often combined with endoscopic sphincterotomy (EST), may prevent post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP). However, sepsis-induced coagulopathy (SIC) increases bleeding risk, raising concerns about EST safety.</p><p><strong>Aims: </strong>To evaluate the risk of adverse events (AEs) and clinical outcomes associated with EBD with or without EST in patients with AC and SIC.</p><p><strong>Methods: </strong>In this retrospective multicentre cohort study, data from enrolled patients were analysed using propensity score matching, and outcomes were compared between EST and non-EST groups. The primary endpoint was the AE rate difference between EBD with and without EST. Secondary endpoints included differences in clinical outcomes.</p><p><strong>Results: </strong>Among 238 patients, 72 underwent EST and 166 did not. The AE incidence, particularly bleeding-related (11.1% vs. 0.6%, P<.001), was higher in the EST group (16.7% vs. 1.8%, P<.001) while PEP incidence (4.2% vs. 1.2%, P=.143) did not differ. Propensity score-matched analysis confirmed these findings. Clinical success or 28-day survival rates did not differ significantly.</p><p><strong>Conclusion: </strong>EST significantly increases bleeding risk in patients with AC and SIC without reducing PEP incidence or improving clinical outcomes. EBD without EST can minimise bleeding risk while maintaining adequate biliary drainage.</p>","PeriodicalId":11268,"journal":{"name":"Digestive and Liver Disease","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146141096","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 : 2026-02-03DOI: 10.1016/j.dld.2026.01.210
Maud Gendard, Philippe Seksik, Carmen Stefanescu, Antoine Meyer, Maria Nachury, Stéphane Nancey, Guillaume Savoye, Matthieu Allez, David Laharie, Mélanie Serrero, Denis Franchimont, Nicolas Mathieu, Mathurin Fumery, Lucine Vuitton, Stéphane Nahon, Cyrielle Gilletta, Cléa Rouillon, Alexandre Nuzzo, Catherine Le Berre, Bénédicte Caron, Anthony Buisson, Morgane Amil, Maëva Charkaoui, Guillaume Cadiot, Ludovic Caillo, Marion Simon, Catherine Reenaers, Xavier Hébuterne, Laurianne Plastaras, Calina Atanasiu, Sandy Kwiatek, Mathieu Uzzan, Anne-Laure Pelletier, Alban Benezech, Mathias Vidon, Felix Goutorbe, Sophie Geyl, Christophe Cellier, Céline Montuclard, Driffa Moussata, Romain Altwegg, Aurélien Amiot
Background and aims: The impact of Physical activity (PA) on the activity of inflammatory bowel disease (IBD) remains unclear.
Patients and methods: A descriptive cross-sectional study included consecutive patients with Crohn's disease (CD), ulcerative colitis (UC). PA was assessed using the short International Physical Activity Questionnaire. PA was classified as low, medium or high PA. PA was also assessed according to WHO recommendations. IBD activity was evaluated using PRO-2, while IBD-related disability was assessed with the IBD-disk questionnaire.
Results: Among a total of 2514 patients (1715 CD), only 28.8% met the WHO recommendations on PA (49.8% had low PA, 35.2% had medium PA, and 15.0% had high PA). Medium and high PA levels were associated with a higher rate of patient-reported clinical remission in patients with CD (OR 1.30 [1.08-1.57] for medium PA, and 1.33 [1.03-1.72] for high PA vs. low PA; p-trend=0.02) but not in those with UC. Higher PA levels were associated with less IBD-related disability in both CD, and UC.
Conclusion: In a large cohort of IBD patients, moderate and high PA was associated with higher rates of clinical remission in patients with CD and lower IBD-related disability in both CD and UC patients.
{"title":"Association between physical activity with disease activity and functional disability in patients with inflammatory bowel disease.","authors":"Maud Gendard, Philippe Seksik, Carmen Stefanescu, Antoine Meyer, Maria Nachury, Stéphane Nancey, Guillaume Savoye, Matthieu Allez, David Laharie, Mélanie Serrero, Denis Franchimont, Nicolas Mathieu, Mathurin Fumery, Lucine Vuitton, Stéphane Nahon, Cyrielle Gilletta, Cléa Rouillon, Alexandre Nuzzo, Catherine Le Berre, Bénédicte Caron, Anthony Buisson, Morgane Amil, Maëva Charkaoui, Guillaume Cadiot, Ludovic Caillo, Marion Simon, Catherine Reenaers, Xavier Hébuterne, Laurianne Plastaras, Calina Atanasiu, Sandy Kwiatek, Mathieu Uzzan, Anne-Laure Pelletier, Alban Benezech, Mathias Vidon, Felix Goutorbe, Sophie Geyl, Christophe Cellier, Céline Montuclard, Driffa Moussata, Romain Altwegg, Aurélien Amiot","doi":"10.1016/j.dld.2026.01.210","DOIUrl":"https://doi.org/10.1016/j.dld.2026.01.210","url":null,"abstract":"<p><strong>Background and aims: </strong>The impact of Physical activity (PA) on the activity of inflammatory bowel disease (IBD) remains unclear.</p><p><strong>Patients and methods: </strong>A descriptive cross-sectional study included consecutive patients with Crohn's disease (CD), ulcerative colitis (UC). PA was assessed using the short International Physical Activity Questionnaire. PA was classified as low, medium or high PA. PA was also assessed according to WHO recommendations. IBD activity was evaluated using PRO-2, while IBD-related disability was assessed with the IBD-disk questionnaire.</p><p><strong>Results: </strong>Among a total of 2514 patients (1715 CD), only 28.8% met the WHO recommendations on PA (49.8% had low PA, 35.2% had medium PA, and 15.0% had high PA). Medium and high PA levels were associated with a higher rate of patient-reported clinical remission in patients with CD (OR 1.30 [1.08-1.57] for medium PA, and 1.33 [1.03-1.72] for high PA vs. low PA; p-trend=0.02) but not in those with UC. Higher PA levels were associated with less IBD-related disability in both CD, and UC.</p><p><strong>Conclusion: </strong>In a large cohort of IBD patients, moderate and high PA was associated with higher rates of clinical remission in patients with CD and lower IBD-related disability in both CD and UC patients.</p>","PeriodicalId":11268,"journal":{"name":"Digestive and Liver Disease","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146117631","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 : 2026-01-31DOI: 10.1016/j.dld.2026.01.205
Tao Fan, Jian Wang, Li Zhu, Ye Xiong, Shaoqiu Zhang, Jiacheng Liu, Chao Jiang, Shengxia Yin, Xin Tong, Guiyang Wang, Bei Jia, Juan Xia, Xiaomin Yan, Renling Yao, Yuxin Chen, Yu Shi, Xingxiang Liu, Yuanwang Qiu, Taoran Geng, Qun Zhang, Chuanwu Zhu, Chao Wu, Rui Huang
Background: The association between serum HBV DNA levels and liver fibrosis in patients with chronic hepatitis B (CHB) remains controversial. We investigated this association in non-cirrhotic CHB patients.
Methods: A total of 5,880 non-cirrhotic treatment-naïve CHB patients with ALT ≤2 × ULN were retrospectively included. Liver fibrosis was evaluated using FIB-4, APRI, LSM, or liver histology.
Results: The CHB patients had a median age of 38.0 years and 57.6% were male. There was a non-linear, parabolic association between serum HBV DNA loads and non-invasive fibrosis tests (APRI, FIB-4, and LSM). Patients with moderate serum HBV DNA levels (around 6 log10 IU/mL) had the highest APRI, FIB-4, and LSM values. After adjustment, the non-linear relationship between serum HBV DNA loads and non-invasive liver fibrosis indicators remained significant, especially in HBeAg-positive patients. Patients with moderate serum HBV DNA levels (around 6 log10 IU/mL) had the highest proportion of significant liver fibrosis as determined by APRI, FIB-4, LSM, and liver biopsy.
Conclusions: A non-linear association was observed between serum HBV DNA levels and liver fibrosis in non-cirrhotic, treatment-naïve CHB patients with ALT ≤2 × ULN, with moderate HBV DNA levels (around 6 log₁₀ IU/mL) associated with a higher risk of fibrosis.
{"title":"Association between serum HBV DNA levels and liver fibrosis in chronic hepatitis B.","authors":"Tao Fan, Jian Wang, Li Zhu, Ye Xiong, Shaoqiu Zhang, Jiacheng Liu, Chao Jiang, Shengxia Yin, Xin Tong, Guiyang Wang, Bei Jia, Juan Xia, Xiaomin Yan, Renling Yao, Yuxin Chen, Yu Shi, Xingxiang Liu, Yuanwang Qiu, Taoran Geng, Qun Zhang, Chuanwu Zhu, Chao Wu, Rui Huang","doi":"10.1016/j.dld.2026.01.205","DOIUrl":"https://doi.org/10.1016/j.dld.2026.01.205","url":null,"abstract":"<p><strong>Background: </strong>The association between serum HBV DNA levels and liver fibrosis in patients with chronic hepatitis B (CHB) remains controversial. We investigated this association in non-cirrhotic CHB patients.</p><p><strong>Methods: </strong>A total of 5,880 non-cirrhotic treatment-naïve CHB patients with ALT ≤2 × ULN were retrospectively included. Liver fibrosis was evaluated using FIB-4, APRI, LSM, or liver histology.</p><p><strong>Results: </strong>The CHB patients had a median age of 38.0 years and 57.6% were male. There was a non-linear, parabolic association between serum HBV DNA loads and non-invasive fibrosis tests (APRI, FIB-4, and LSM). Patients with moderate serum HBV DNA levels (around 6 log<sub>10</sub> IU/mL) had the highest APRI, FIB-4, and LSM values. After adjustment, the non-linear relationship between serum HBV DNA loads and non-invasive liver fibrosis indicators remained significant, especially in HBeAg-positive patients. Patients with moderate serum HBV DNA levels (around 6 log<sub>10</sub> IU/mL) had the highest proportion of significant liver fibrosis as determined by APRI, FIB-4, LSM, and liver biopsy.</p><p><strong>Conclusions: </strong>A non-linear association was observed between serum HBV DNA levels and liver fibrosis in non-cirrhotic, treatment-naïve CHB patients with ALT ≤2 × ULN, with moderate HBV DNA levels (around 6 log₁₀ IU/mL) associated with a higher risk of fibrosis.</p>","PeriodicalId":11268,"journal":{"name":"Digestive and Liver Disease","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146099534","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 : 2026-01-31DOI: 10.1016/j.dld.2026.01.214
Valentina Flagiello, Paolo Gallo, Francesca Terracciani, Antonio De Vincentis, Antonio Picardi, Umberto Vespasiani-Gentilucci
{"title":"Author's reply: \"Beyond a single metric: A stratified algorithm for non-invasive risk assessment in MASLD\".","authors":"Valentina Flagiello, Paolo Gallo, Francesca Terracciani, Antonio De Vincentis, Antonio Picardi, Umberto Vespasiani-Gentilucci","doi":"10.1016/j.dld.2026.01.214","DOIUrl":"https://doi.org/10.1016/j.dld.2026.01.214","url":null,"abstract":"","PeriodicalId":11268,"journal":{"name":"Digestive and Liver Disease","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146099510","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 : 2026-01-31DOI: 10.1016/j.dld.2026.01.211
Gael S Roth, Jérôme Cros, Cindy Neuzillet, Emilie Barbier, Meriem Guarssifi, Amel Bennacer, Michel Ducreux, Marie Muller, Julien Edeline, Sylvain Manfredi, Nicolas Williet, Nelson Dusetti, Pierre Laurent-Puig, Victoire Ruffino, Brice Chanez, Rémy Nicolle, Julien Taieb, David Malka
Background: Ampullary adenocarcinoma (AAC) is a rare and aggressive cancer with a 5-year overall survival (OS) rate ranging from 30% to 67% after resection due to a high recurrence rate. Yet, adjuvant therapy's role is still debated. Recent French FFCD-AC cohort study highlighted that adjuvant therapy, can benefit intermediate and high-risk patients. Chemotherapy regimens, include gemcitabine and 5-fluorouracil (5FU) but practices are highly heterogenous due to the low level of evidence. Previous studies suggest that combination chemotherapy, such as mFOLFIRINOX, could offer improved outcomes.
Design: PRODIGE 98 - AMPIRINOX trial (NCT06813976) is a multicenter, open-label, randomized phase 3 trial designed to compare the efficacy of adjuvant mFOLFIRINOX versus single-agent chemotherapy (capecitabine or gemcitabine) in patients with resected AAC. Primary outcome is disease free survival and secondary outcomes include overall survival (OS), safety and quality of life. Patients (ages 18-79) must have undergone macroscopically complete (R0/R1) resection of AAC, with exclusion of patients previously treated with chemotherapy, and pT1N0M0 tumors. Ancillary studies will focus on an in-depth molecular profiling of AAC to identify prognostic and predictive biomarkers. AMPIRINOX is currently recruiting and is expected to provide essential data on how to optimize treatment for AAC patients in the coming years.
{"title":"Randomized, multicenter Phase III trial of adjuvant chemotherapy with modified FOLFIRINOX versus capecitabine or gemcitabine in patients with resected ampullary adenocarcinoma.","authors":"Gael S Roth, Jérôme Cros, Cindy Neuzillet, Emilie Barbier, Meriem Guarssifi, Amel Bennacer, Michel Ducreux, Marie Muller, Julien Edeline, Sylvain Manfredi, Nicolas Williet, Nelson Dusetti, Pierre Laurent-Puig, Victoire Ruffino, Brice Chanez, Rémy Nicolle, Julien Taieb, David Malka","doi":"10.1016/j.dld.2026.01.211","DOIUrl":"https://doi.org/10.1016/j.dld.2026.01.211","url":null,"abstract":"<p><strong>Background: </strong>Ampullary adenocarcinoma (AAC) is a rare and aggressive cancer with a 5-year overall survival (OS) rate ranging from 30% to 67% after resection due to a high recurrence rate. Yet, adjuvant therapy's role is still debated. Recent French FFCD-AC cohort study highlighted that adjuvant therapy, can benefit intermediate and high-risk patients. Chemotherapy regimens, include gemcitabine and 5-fluorouracil (5FU) but practices are highly heterogenous due to the low level of evidence. Previous studies suggest that combination chemotherapy, such as mFOLFIRINOX, could offer improved outcomes.</p><p><strong>Design: </strong>PRODIGE 98 - AMPIRINOX trial (NCT06813976) is a multicenter, open-label, randomized phase 3 trial designed to compare the efficacy of adjuvant mFOLFIRINOX versus single-agent chemotherapy (capecitabine or gemcitabine) in patients with resected AAC. Primary outcome is disease free survival and secondary outcomes include overall survival (OS), safety and quality of life. Patients (ages 18-79) must have undergone macroscopically complete (R0/R1) resection of AAC, with exclusion of patients previously treated with chemotherapy, and pT1N0M0 tumors. Ancillary studies will focus on an in-depth molecular profiling of AAC to identify prognostic and predictive biomarkers. AMPIRINOX is currently recruiting and is expected to provide essential data on how to optimize treatment for AAC patients in the coming years.</p>","PeriodicalId":11268,"journal":{"name":"Digestive and Liver Disease","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146099723","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 : 2026-01-31DOI: 10.1016/j.dld.2025.12.032
Pedro Mesquita, Rolando Pinho, Adélia Rodrigues, Catarina Costa, Pedro Teixeira, Rita Ferreira, Ana Ponte, Teresa Freitas
Background: Small bowel capsule endoscopy (SBCE) is central to Crohn's Disease (CD) care but limited by lengthy review and reader variability. We tested whether an artificial-intelligence (AI)-triaged, human-reviewed workflow - SmartScan, SS - can serve as a first-line alternative to full-video (FV) review, reducing reading time while maintaining safety and score fidelity.
Methods: Single-center, randomized, assessor-blinded, dual-reader, 2 × 2 crossover non-inferiority reading study of OMOM® HD SBCE videos in adults with established CD. Each study underwent paired FV and SS reads. The primary endpoint was non-inferiority of the agreement on Lewis Score (LS) activity category plus stricture status. Secondary endpoints included LS category agreement, equivalence of continuous LS/CECDAI, within-tolerance agreement, stricture sensitivity, performance with short transit and low Brotz quality, and reading-time superiority.
Results: We analyzed 153 paired studies. SS and FV agreed on both LS category and stricture in 96.1 % (147/153), surpassing the non-inferiority (NI) margin (p = 0.005). LS category exact match was 96.7 %. Continuous scores were equivalent, and stricture sensitivity 100 % (11/11). Within-tolerance agreement was 91.5 % (140/153) but failed to meet the prespecified NI criteria. Results were similar with short transit and low Brotz quality. Mean reading time fell from 41.5 to 12.8 min (p < 0.001).
Conclusions: SS achieved NI for the primary composite endpoint and preserved equivalence of continuous LS/CECDAI, while markedly reduced reading time. These data support an AI-triaged, human-reviewed workflow with selective escalation to FV when uncertainty arises.
{"title":"OMOM SmartScan provides noninferior assessment of Lewis score and CECDAI in Crohn's disease vs full-video review.","authors":"Pedro Mesquita, Rolando Pinho, Adélia Rodrigues, Catarina Costa, Pedro Teixeira, Rita Ferreira, Ana Ponte, Teresa Freitas","doi":"10.1016/j.dld.2025.12.032","DOIUrl":"https://doi.org/10.1016/j.dld.2025.12.032","url":null,"abstract":"<p><strong>Background: </strong>Small bowel capsule endoscopy (SBCE) is central to Crohn's Disease (CD) care but limited by lengthy review and reader variability. We tested whether an artificial-intelligence (AI)-triaged, human-reviewed workflow - SmartScan, SS - can serve as a first-line alternative to full-video (FV) review, reducing reading time while maintaining safety and score fidelity.</p><p><strong>Methods: </strong>Single-center, randomized, assessor-blinded, dual-reader, 2 × 2 crossover non-inferiority reading study of OMOM® HD SBCE videos in adults with established CD. Each study underwent paired FV and SS reads. The primary endpoint was non-inferiority of the agreement on Lewis Score (LS) activity category plus stricture status. Secondary endpoints included LS category agreement, equivalence of continuous LS/CECDAI, within-tolerance agreement, stricture sensitivity, performance with short transit and low Brotz quality, and reading-time superiority.</p><p><strong>Results: </strong>We analyzed 153 paired studies. SS and FV agreed on both LS category and stricture in 96.1 % (147/153), surpassing the non-inferiority (NI) margin (p = 0.005). LS category exact match was 96.7 %. Continuous scores were equivalent, and stricture sensitivity 100 % (11/11). Within-tolerance agreement was 91.5 % (140/153) but failed to meet the prespecified NI criteria. Results were similar with short transit and low Brotz quality. Mean reading time fell from 41.5 to 12.8 min (p < 0.001).</p><p><strong>Conclusions: </strong>SS achieved NI for the primary composite endpoint and preserved equivalence of continuous LS/CECDAI, while markedly reduced reading time. These data support an AI-triaged, human-reviewed workflow with selective escalation to FV when uncertainty arises.</p>","PeriodicalId":11268,"journal":{"name":"Digestive and Liver Disease","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146099727","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}