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Clinical prediction models in minimal hepatic encephalopathy: how far can they go? 最小肝性脑病的临床预测模型:它们能走多远?
IF 3.8 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-02-07 DOI: 10.1016/j.dld.2026.01.221
Lorenzo Ridola
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引用次数: 0
Reconsidering the clinical implications of oral butyrate supplementation in inflammatory bowel disease. 重新考虑口服丁酸盐补充治疗炎症性肠病的临床意义。
IF 3.8 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-02-07 DOI: 10.1016/j.dld.2026.01.001
Yanqin Zhang, Liuhong Dai, Teng Ma
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引用次数: 0
Rapidly growing esophageal pyogenic granuloma: A case report and review of the literature. 快速生长的食道化脓性肉芽肿1例报告及文献复习。
IF 3.8 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-02-07 DOI: 10.1016/j.dld.2026.01.209
Xiaoxia Zhang, Jianjun Li, Xinwei Diao, Ying Huang, Qiujian Qiao, Jianying Bai, Xue Peng

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.

化脓性肉芽肿(PG)或小叶毛细血管瘤(LCH)是一种以快速生长、结节性增生和出血倾向为特征的良性血管肿瘤。虽然常见于皮肤/口腔黏膜,但食道少见。我们报告一位34岁男性复发性胃酸反流。上镜检查(2022年7月)发现食管胃交界处上方有一个10毫米息肉样病变,13个月前未见。经黏膜下生理盐水注射后,经内镜粘膜切除术(EMR)成功切除,组织学证实为食管PG (LCH)。我们的文献综述确定并分析了21个先前的详细病例。对22例病例的分析显示,这些病变主要发生在亚洲男性(M:F=19:3,平均年龄57.8±14.8岁)。大多数患者(71.6%)有症状,主要表现为吞咽困难或胃肠道出血。近一半(50.0%)发生在食管下部,平均大小为11.5±6.2 mm。超过50%表现为红色,渗出物覆盖的结节,典型的有花序梗或半有花序梗。电子病历有效地管理了大多数病例。本报告强调了食管PG的快速发展潜力,并支持EMR的诊断/治疗效果,强调了认识到这种罕见实体并进行适当治疗的重要性。
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引用次数: 0
Sphincterotomy during endoscopic biliary drainage in cholangitis with sepsis-induced coagulopathy increases bleeding without clinical benefits. 胆管炎合并脓毒症引起的凝血功能障碍的内镜胆道引流术中括约肌切开术会增加出血,但无临床益处。
IF 3.8 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-02-07 DOI: 10.1016/j.dld.2026.01.218
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

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.

背景:急性胆管炎(AC)危及生命,需要紧急胆道引流。内镜下胆道引流(EBD),通常联合内镜下括约肌切开术(EST),可以预防内镜后逆行胆管胰腺炎(PEP)。然而,败血症诱导凝血功能障碍(SIC)增加出血风险,引起对EST安全性的担忧。目的:评估伴有或不伴有EST的AC和SIC患者与EBD相关的不良事件(ae)风险和临床结果。方法:在这项回顾性多中心队列研究中,使用倾向评分匹配分析入组患者的数据,并比较EST组和非EST组的结果。主要终点是伴有和不伴有EST的EBD的AE率差异,次要终点包括临床结果的差异。结果:238例患者中,72例行EST, 166例未行EST。结论:EST显著增加AC和SIC患者出血风险,但未降低PEP发生率或改善临床结果。没有EST的EBD可以在保持充足的胆道引流的同时将出血风险降至最低。
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引用次数: 0
Association between physical activity with disease activity and functional disability in patients with inflammatory bowel disease. 炎症性肠病患者身体活动与疾病活动和功能残疾之间的关系
IF 3.8 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-02-03 DOI: 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.

背景和目的:体育锻炼(PA)对炎症性肠病(IBD)活动性的影响尚不清楚。患者和方法:一项描述性横断面研究包括克罗恩病(CD),溃疡性结肠炎(UC)的连续患者。使用简短的国际体育活动问卷评估PA。PA分为低、中、高三个等级。还根据世卫组织的建议评估了PA。使用PRO-2评估IBD活性,而使用IBD磁盘问卷评估IBD相关残疾。结果:在2514例患者(1715例CD)中,只有28.8%的患者符合WHO推荐的PA(49.8%为低PA, 35.2%为中等PA, 15.0%为高PA)。在CD患者中,中、高PA水平与较高的患者报告的临床缓解率相关(中PA为1.30[1.08-1.57],高PA与低PA为1.33 [1.03-1.72];p趋势=0.02),但UC患者无此相关性。在CD和UC中,较高的PA水平与较少的ibd相关残疾相关。结论:在一个大型IBD患者队列中,中度和高PA与较高的CD患者临床缓解率和较低的UC和CD患者IBD相关致残率相关。
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引用次数: 0
Association between serum HBV DNA levels and liver fibrosis in chronic hepatitis B. 慢性乙型肝炎患者血清HBV DNA水平与肝纤维化的关系
IF 3.8 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-31 DOI: 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.

背景:慢性乙型肝炎(CHB)患者血清HBV DNA水平与肝纤维化之间的关系仍存在争议。我们在非肝硬化CHB患者中调查了这种关联。方法:回顾性分析5880例ALT≤2 × ULN的非肝硬化treatment-naïve CHB患者。采用FIB-4、APRI、LSM或肝组织学评估肝纤维化。结果:CHB患者中位年龄为38.0岁,男性占57.6%。血清HBV DNA载量与非侵入性纤维化试验(APRI、FIB-4和LSM)之间呈非线性抛物线关系。血清HBV DNA水平中等(约6 log10 IU/mL)的患者APRI、FIB-4和LSM值最高。调整后,血清HBV DNA载量与非侵袭性肝纤维化指标之间的非线性关系仍然显著,特别是在hbeag阳性患者中。通过APRI、FIB-4、LSM和肝活检检测,血清HBV DNA水平中等(约6 log10 IU/mL)的患者发生显著肝纤维化的比例最高。结论:在ALT≤2 × ULN的非肝硬化treatment-naïve CHB患者中,血清HBV DNA水平与肝纤维化之间存在非线性关联,中等HBV DNA水平(约6 log₁₀IU/mL)与较高的纤维化风险相关。
{"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}
引用次数: 0
Author's reply: "Beyond a single metric: A stratified algorithm for non-invasive risk assessment in MASLD". 作者回复:“超越单一指标:MASLD非侵入性风险评估的分层算法”。
IF 3.8 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-31 DOI: 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}
引用次数: 0
Author's Reply: ``Helicobacter pylori Infection with metabolic-associated fatty liver disease and Colorectal Neoplasms''. 作者回复:“幽门螺杆菌感染与代谢性脂肪性肝病和结直肠肿瘤”。
IF 3.8 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-31 DOI: 10.1016/j.dld.2026.01.213
Shiyu Peng, Yanling Wei, Hui Xiang, Qiang Zhu, Shuxin Tian
{"title":"Author's Reply: ``Helicobacter pylori Infection with metabolic-associated fatty liver disease and Colorectal Neoplasms''.","authors":"Shiyu Peng, Yanling Wei, Hui Xiang, Qiang Zhu, Shuxin Tian","doi":"10.1016/j.dld.2026.01.213","DOIUrl":"https://doi.org/10.1016/j.dld.2026.01.213","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":"146099512","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}
引用次数: 0
Randomized, multicenter Phase III trial of adjuvant chemotherapy with modified FOLFIRINOX versus capecitabine or gemcitabine in patients with resected ampullary adenocarcinoma. 随机、多中心III期试验:改良FOLFIRINOX与卡培他滨或吉西他滨在切除壶腹腺癌患者中的辅助化疗
IF 3.8 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-31 DOI: 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.

背景:壶腹腺癌(AAC)是一种罕见的侵袭性癌症,由于其高复发率,术后5年总生存率(OS)为30% ~ 67%。然而,辅助治疗的作用仍然存在争议。最近法国FFCD-AC队列研究强调,辅助治疗可以使中高危患者受益。化疗方案包括吉西他滨和5-氟尿嘧啶(5FU),但由于证据水平低,实践高度异质性。先前的研究表明,联合化疗,如mFOLFIRINOX,可以提供更好的结果。设计:PRODIGE 98 - AMPIRINOX试验(NCT06813976)是一项多中心、开放标签、随机3期试验,旨在比较辅助mFOLFIRINOX与单药化疗(卡培他滨或吉西他滨)对AAC切除患者的疗效。主要终点是无病生存期,次要终点包括总生存期(OS)、安全性和生活质量。患者(年龄18-79岁)必须接受宏观完全(R0/R1) AAC切除术,排除先前接受化疗的患者和pT1N0M0肿瘤。辅助研究将集中于AAC的深入分子分析,以确定预后和预测性生物标志物。AMPIRINOX目前正在招募,预计将在未来几年为AAC患者提供优化治疗的基本数据。
{"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}
引用次数: 0
OMOM SmartScan provides noninferior assessment of Lewis score and CECDAI in Crohn's disease vs full-video review. OMOM SmartScan对克罗恩病的Lewis评分和CECDAI进行非劣等评估。
IF 3.8 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-31 DOI: 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.

背景:小肠胶囊内窥镜(SBCE)是克罗恩病(CD)治疗的核心,但受到冗长的综述和读者差异的限制。我们测试了人工智能(AI)分类、人工审核的工作流程(SmartScan, SS)是否可以作为全视频(FV)审核的一线替代方案,在保持安全性和评分保真度的同时减少阅读时间。方法:单中心、随机、评估盲、双阅读器、2 × 2交叉非劣效性阅读研究,对已确诊CD的成人进行OMOM®HD SBCE视频阅读。每项研究都进行配对的FV和SS阅读。主要终点为Lewis评分(LS)活动类别和结构状态的一致性非劣效性。次要终点包括LS类别一致性、连续LS/CECDAI的等效性、公差内一致性、结构敏感性、短传输和低Brotz质量性能、阅读时间优势。结果:我们分析了153项配对研究。SS和FV在LS类别和狭窄上的一致性为96.1%(147/153),超过了非劣效性(NI)界限(p = 0.005)。LS分类精确匹配率为96.7%。连续评分相等,狭窄敏感性100%(11/11)。容忍范围内的一致性为91.5%(140/153),但未能满足预先规定的NI标准。结果相似,过境短,布罗茨质量低。平均阅读时间从41.5分钟下降到12.8分钟(p < 0.001)。结论:SS在主要复合终点达到NI,并保持了连续LS/CECDAI的等效性,同时显著缩短了阅读时间。这些数据支持人工智能分类、人工审核的工作流程,当出现不确定性时,可以选择性地升级到FV。
{"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}
引用次数: 0
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Digestive and Liver Disease
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