Therapeutic Advances in Gastroenterology最新文献

{"title":"Tegoprazan and low- or high-dose amoxicillin dual therapy versus bismuth-containing quadruple therapy for <i>Helicobacter pylori</i> eradication (TREAT): protocol for a multicenter, open-label, non-inferiority, randomized controlled trial.","authors":"Yi Hu, Xin Xu, Cong He, Nian-Shuang Li, Yong Xie, Xu Shu, Nong-Hua Lu, Yin Zhu","doi":"10.1177/17562848251366374","DOIUrl":"10.1177/17562848251366374","url":null,"abstract":"<p><strong>Background: </strong>Recently, tegoprazan was widely used for the treatment of acid-related diseases, including <i>Helicobacter pylori</i> (<i>H. pylori</i>) infection. However, the optimized parameters of tegoprazan and amoxicillin used in dual therapy for eradicating <i>H. pylori</i> remained unresolved.</p><p><strong>Objectives: </strong>We mainly aim to compare the efficacy and safety of 14-day tegoprazan and low-dose amoxicillin dual therapy (LTA) or high-dose amoxicillin dual therapy (HTA) with 14-day bismuth-containing quadruple therapy (BQT) as first-line treatment of <i>H. pylori</i> infection. The antibiotic resistance and the impacts of therapy on gut microbiota are also evaluated.</p><p><strong>Design: </strong>Study protocol for a multicenter, open-label, non-inferiority, randomized controlled trial.</p><p><strong>Methods and analysis: </strong>This trial will recruit <i>H. pylori</i>-infected individuals aged 18-70 years without previous eradication. Participants will be randomized in a 1:1:1 ratio to LTA (amoxicillin 1 g twice a day and tegoprazan 50 mg three times daily), HTA (amoxicillin 1 g and tegoprazan 50 mg both three times daily), or BQT (amoxicillin 1 g, clarithromycin 500 mg, esomeprazole 20 mg, and bismuth potassium citrate 220 mg all twice daily) for 14 days using block size of 6. Stool samples will be collected at baseline to detect antibiotic resistance and at baseline, week 2, and weeks 8-10 to evaluate the alteration of gut microbiota. The primary outcome is the eradication rate of <i>H. pylori</i>, assessed by ¹³C urea breath test, in intention-to-treat, modified intention-to-treat, and per-protocol analyses. Secondary outcomes include adverse events, adherence, antibiotic resistance, and alterations to the gut microbiota.</p><p><strong>Ethics: </strong>This study has been approved by the Ethics Committee of the First Affiliated Hospital of Nanchang University (No. 2024150-2). Ethics approval of each participating center is required before initiation of enrollment. Written informed consent to participate will be obtained from all participants.</p><p><strong>Discussion: </strong>This is the first study to investigate the safety and efficacy of 14-day tegoprazan with different dosages of amoxicillin therapies in comparison with BQT. The outcomes of this study will optimize the use of tegoprazan dual therapy for <i>H. pylori</i> eradication.</p><p><strong>Trial registration: </strong>The trial was registered on the Chinese Clinical Trial Registry (ChiCTR2400089979) on 20th September 2024.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251366374"},"PeriodicalIF":3.4,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12361733/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144975283","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost-effectiveness of cadonilimab plus chemotherapy in the first-line treatment of HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma.","authors":"Shixian Liu, Kaixuan Wang, Ruixue Wang, Hao Chen, Ziming Wan, Lei Dou, Shunping Li","doi":"10.1177/17562848251366946","DOIUrl":"10.1177/17562848251366946","url":null,"abstract":"<p><strong>Background: </strong>The COMPASSION-15 clinical trial demonstrated that cadonilimab plus chemotherapy significantly improved clinical benefits in human epidermal growth factor receptor 2-negative (HER2-) advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.</p><p><strong>Objectives: </strong>This study investigated the cost-effectiveness of cadonilimab plus chemotherapy in the first-line treatment for HER2- advanced G/GEJ adenocarcinoma from the Chinese healthcare system perspective.</p><p><strong>Design: </strong>Economic evaluation.</p><p><strong>Methods: </strong>We compared three treatment regimens based on the COMPASSION-15 trial, including chemotherapy, cadonilimab plus chemotherapy, and programmed death ligand 1 (PD-L1) test-guided treatment. A partitioned survival model was constructed at 21-day cycle lengths over a 10-year time horizon to predict total costs, life-years, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER) under the willingness-to-pay (WTP) threshold of three times the gross domestic product per capita ($40,334.05). Model parameters were obtained from a public bid-winning database and published literature. Scenario, one-way, and probabilistic sensitivity analyses were used to test the robustness of the model.</p><p><strong>Results: </strong>In the base case, the costs of chemotherapy, PD-L1 test-guided treatment, and cadonilimab plus chemotherapy were $7,207.78, $15,776.35, and $22,294.58, with QALYs of 0.59, 0.71, and 0.79, respectively. The ICERs of PD-L1 test-guided treatment and cadonilimab plus chemotherapy were $68,751.00 and $76,120.27 per QALY. The ICERs of cadonilimab plus chemotherapy were $58,469.16 and $121,123.92 per QALY for PD-L1 combined positive score (CPS) ⩾ 5 and <5 HER2- advanced G/GEJ adenocarcinoma. The cost of cadonilimab and patient weight were the most influential model parameters. Cadonilimab plus chemotherapy had a 0.01% cost-effectiveness in China.</p><p><strong>Conclusion: </strong>Cadonilimab plus chemotherapy might be a cost-effective regimen when the unit cost of cadonilimab was $151.48 (58% discount) and $188.04 (72% discount) for overall and PD-L1 CPS ⩾ 5 advanced G/GEJ adenocarcinoma.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251366946"},"PeriodicalIF":3.4,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12365449/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144975306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of inflammatory bowel disease-related sleep disorders based on an interpretable machine learning approach: a multicenter study in China.","authors":"Jiayi Sun, Junhai Zhen, Chuan Liu, Changqing Jiang, Jie Shi, Kaichun Wu, Weiguo Dong","doi":"10.1177/17562848251359141","DOIUrl":"10.1177/17562848251359141","url":null,"abstract":"<p><strong>Background: </strong>Patients with inflammatory bowel disease (IBD) often encounter complications such as sleep disorders, which are of great detriment to their quality of life, and earlier identification and intervention can effectively improve the prognosis of patients.</p><p><strong>Objectives: </strong>In this study, we worked on building a risk model to assess IBD-related sleep disorders using a machine learning (ML) approach.</p><p><strong>Design: </strong>Observational study.</p><p><strong>Methods: </strong>Based on an online questionnaire, we collected clinical data from 2478 IBD patients from 42 hospitals in 22 Chinese provinces between September 2021 and May 2022. Then, we developed and validated six common ML models to assess the risk of co-morbid sleep disorders in IBD patients, and evaluated and compared the performance of these models using relevant metrics. Finally, the Local Interpretable Model-Agnostic Explanations algorithm (Lime) was utilized to interpret the results of the best ML model.</p><p><strong>Results: </strong>In this study, after multidimensional comparisons, the voting model was finally identified as superior among several models, with the area under the curve and accuracy reaching 0.76 and 0.74, respectively. After calculations, it was found that the co-morbidities of depression and anxiety, an older age, outpatient diagnosis, and a longer course of the disease were all indicative of a higher risk of sleep disorders among IBD patients in this model.</p><p><strong>Conclusion: </strong>The construction of risk assessment models using ML has high clinical value in the prediction of IBD-related sleep disorders, and the efficacy of its application suggests it can serve as a promising evaluation tool in clinical work.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251359141"},"PeriodicalIF":3.4,"publicationDate":"2025-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12358002/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144876291","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Artificial intelligence-based multimodal model for the identification of ulcerative colitis with concomitant cytomegalovirus colitis.","authors":"Haozheng Liang, Yuxuan Tian, Gechong Ruan, Xiaoyin Bai, Wei Han, Xiangling Fu, Yuhang Wang, Jialin Shi, Yinghao Sun, Ji Wu, Chenyi Guo, Hong Yang","doi":"10.1177/17562848251364194","DOIUrl":"10.1177/17562848251364194","url":null,"abstract":"<p><strong>Background: </strong>Ulcerative colitis (UC), a chronic immune-mediated colon inflammation, impacts patients' quality of life. Immunosuppressive-treated UC patients are prone to opportunistic infections like cytomegalovirus (CMV) infection, which exacerbates UC, causes steroid resistance, and elevates surgery and mortality risks. Identifying CMV colitis from UC exacerbation is difficult due to overlapping symptoms and low biopsy detection rates.</p><p><strong>Objectives: </strong>To develop an artificial intelligence (AI)-based multimodal model for early identification of UC with concomitant CMV colitis.</p><p><strong>Design: </strong>This was a retrospective diagnostic study.</p><p><strong>Methods: </strong>A total of 174 moderate to severe UC patients (87 with CMV colitis) from 2015 to 2023 in Peking Union Medical College Hospital were enrolled retrospectively. A total of 3345 colonoscopy images were collected. The dataset was split into training (70%) and testing (30%) sets. A multimodal dynamic affine transformation (DAFT) model integrating clinical biomarkers and endoscopic images was constructed, along with ResNet and SeNet models. Model performance was evaluated using accuracy, sensitivity, specificity, positive and negative predictive values from the confusion matrix.</p><p><strong>Results: </strong>UC patients with CMV colitis had distinct clinical characteristics. The multimodal DAFT model outperformed ResNet and SeNet in distinguishing UC with CMV colitis, with higher accuracy (0.91), sensitivity (0.87), and specificity (0.93).</p><p><strong>Conclusion: </strong>AI application offers a promising way to enhance early identification of UC with CMV colitis. The multimodal model combining clinical and endoscopic data can assist clinicians in accurate and timely diagnosis.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251364194"},"PeriodicalIF":3.4,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12357019/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144876289","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Non-invasive fluorescence sensing reveals changes in intestinal barrier function and gastric emptying rate in a first-in-human study of Crohn's disease.","authors":"Jonathan Gan, Qian Chen, Elena Monfort Sanchez, Nilanjan Mandal, Jiacheng Xu, Zixin Wang, Arjun Agarwal, Emmanuel Oluwatunmise, Pratik Ramkumar, Ash Salam, Elena Chekmeneva, María Gómez-Romero, Lynn Maslen, Sharmili Balarajah, Robert Perry, Karl King Yong, Jonathan Hoare, Nick Powell, James Alexander, James Avery, Hutan Ashrafian, Ara Darzi, Alex J Thompson","doi":"10.1177/17562848251361634","DOIUrl":"10.1177/17562848251361634","url":null,"abstract":"<p><strong>Background: </strong>Crohn's disease is characterised by multifaceted changes in gut function, involving not just inflammatory effects but also alterations in gut barrier function and gastric motility. However, current diagnostic tools used to measure key gut functional parameters are invasive, unreliable or time-consuming. Thus, we applied a novel, non-invasive fluorescence sensing technology - transcutaneous fluorescence spectroscopy (TFS) - to investigate gut barrier function and gastric emptying in Crohn's disease.</p><p><strong>Objectives: </strong>Our study aimed to validate TFS for non-invasive gastrointestinal (GI) diagnostics and to explore changes in gut barrier function and gastric emptying rate simultaneously in Crohn's disease.</p><p><strong>Design: </strong>A cross-sectional study involving patients with Crohn's disease and healthy individuals.</p><p><strong>Methods: </strong>We performed fluorescent measurements and lactulose:mannitol (L:M) tests in 38 Crohn's disease patients and 20 healthy volunteers. We investigated multiple TFS-derived parameters as indicators of gut barrier function and gastric emptying rate. Using these parameters, we assessed differences between healthy volunteers, inactive Crohn's patients and active Crohn's patients, and calculated correlations between TFS and L:M values.</p><p><strong>Results: </strong>TFS-derived parameters revealed significantly increased intestinal permeability and delayed gastric emptying in patients with active Crohn's compared to healthy controls. TFS trends showed encouraging alignment with those from the L:M test, suggesting potential concordance with established methods. No adverse events were reported.</p><p><strong>Conclusion: </strong>TFS enables rapid, non-invasive discrimination of Crohn's patients from healthy volunteers and allows simultaneous assessment of gut barrier function and gastric emptying rate - two important aspects of GI function in Crohn's disease. This implies potential for improved monitoring and diagnosis of Crohn's disease (and other gut disorders) as well as more advanced study of gut function in health and disease.</p><p><strong>Trial registration: </strong>The clinical study reported in this article was registered with ClinicalTrials.gov prior to enrolment of the first participant. https://clinicaltrials.gov/study/NCT03434639 and Registration number: NCT03434639.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251361634"},"PeriodicalIF":3.4,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12357025/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144876292","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drainage-only strategy on weekend for endoscopic retrograde cholangiopancreatography on the risk of procedure-related adverse events: a prospective observational study.","authors":"Eunae Cho, Se Woo Park, Kyong Joo Lee, Da Hae Park, Hyewon Cha, Dong Hee Koh, Jin Lee, Chan Hyuk Park","doi":"10.1177/17562848251361694","DOIUrl":"10.1177/17562848251361694","url":null,"abstract":"<p><strong>Background: </strong>The feasibility of performing complete endoscopic retrograde cholangiopancreatography (ERCP) for acute cholangitis during weekends or holidays remains controversial due to concerns over increased risks of adverse events (AEs) in off-hour procedures.</p><p><strong>Objectives: </strong>To evaluate whether weekend drainage-only ERCP affects the incidence of AEs compared to standard weekday ERCP, and to identify risk factors for post-ERCP pancreatitis (PEP).</p><p><strong>Design: </strong>Prospective observational study.</p><p><strong>Methods: </strong>Patients with acute cholangitis, diagnosed based on the Tokyo Guidelines 2018 and naïve major papillae, were prospectively enrolled between 2018 and 2023. Patients were categorized into two groups: the \"Weekend ERCP\" group, in which initial biliary drainage was performed on weekends with subsequent therapeutic ERCP on weekdays, and the \"Weekday ERCP\" group, in which all procedures were completed during weekdays. The primary outcome was the incidence of PEP; secondary outcomes included overall AEs and risk factor analysis.</p><p><strong>Results: </strong>A total of 1772 patients were included (Weekend group: <i>n</i> = 148; Weekday group: <i>n</i> = 1624) in this study. The incidence of PEP was 4.1% in the Weekend group and 4.9% in the Weekday group (<i>p</i> = 0.810). Overall AEs occurred in 3.4% and 4.9% of patients, respectively (<i>p</i> = 0.540). Multivariable analysis identified age ⩽60 years, female sex, history of acute pancreatitis, difficult cannulation, and endoscopic papillary balloon dilation as independent risk factors for PEP. Timing of ERCP (weekend vs weekday) was not associated with increased risk of PEP.</p><p><strong>Conclusion: </strong>Weekend ERCPs limited to drainage-only strategies are as safe as weekday procedures in terms of AE rates, effectively managing resources and providing timely biliary decompression for acute cholangitis emergencies, although they often require subsequent definitive interventions.</p><p><strong>Trial registration: </strong>The International Clinical Trials Registry Platform (identifier KCT0005950; https://cris.nih.go.kr).</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251361694"},"PeriodicalIF":3.4,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12357021/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144876290","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prospective validation of the Barcelona scale for the assessment of mucosal cleanliness during upper gastrointestinal endoscopy.","authors":"Henry Córdova, Irina Luzko, Javier Tejedor-Tejada, Edgar Castillo-Regalado, Eva Barreiro-Alonso, Pedro Delgado-Guillena, Pilar Diez Redondo, Martin Galdin, Ana García-Rodríguez, Luis Hernández, Ma Henar Núñez Rodríguez, Agustín Seoane, Javier Jiménez Sánchez, Joaquín Cubiella, Rodrigo Jover, Antonio Rodríguez-D'Jesús, Cautar El Maimouni, Leticia Moreira, Oswaldo Ortiz, Joan Llach, Gloria Fernández-Esparrach","doi":"10.1177/17562848251363873","DOIUrl":"10.1177/17562848251363873","url":null,"abstract":"<p><strong>Background: </strong>Some validated scales for assessing upper gastrointestinal (UGI) cleanliness have been developed, though none have been widely implemented.</p><p><strong>Objectives: </strong>To evaluate the association between the presence of clinically significant lesions (CSLs) in the UGI tract and mucosal cleanliness using the Barcelona Scale. The secondary objective includes assessing the safety of water lavage during esophagogastroduodenoscopy (EGD).</p><p><strong>Design: </strong>Multicenter prospective study conducted in 14 hospitals in Spain.</p><p><strong>Methods: </strong>From January 2022 to December 2023, patients undergoing EGD were included. After cleansing, the esophagus, fundus, corpus, antrum, and duodenum were scored from 0 (unassessable due to content) to 2 (fully visualized mucosa), with a maximum score of 10.</p><p><strong>Results: </strong>A total of 641 patients were included, and 3205 segments were assessed: 2594 scored \"2,\" 604 \"1,\" and 7 \"0.\" In 272 patients, 327 CSLs were identified: 93 (14.5%) in the esophagus, 223 (34.8%) in the stomach, and 11 (1.7%) in the duodenum. Only five cases of neoplasia were found, all in segments scored \"2\" (global score ⩾ 9). The CSL detection rates were 0%, 5.3%, and 11.4% for scores 0, 1, and 2, respectively (<i>p</i> < 0.001), with a significantly higher rate for score \"2\" compared to \"1\" (OR 2.29, 95% CI 1.57-3.34). Besides the degree of cleanliness, several factors were independently associated with CSL detection, including the use of a high-definition endoscope (OR 1.87, 95% CI 1.14-3.23), male sex (OR 1.54, 95% CI 1.1-2.17), and age ⩾58 years (OR 1.54, 95% CI 1.09-2.17).</p><p><strong>Conclusion: </strong>The Barcelona scale may be a valid instrument for assessing the quality of cleanliness during EGD in real clinical practice, as it improves the detection of CSL in the UGI.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251363873"},"PeriodicalIF":3.4,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12357016/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144876293","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Identifying inflammatory bowel disease subtypes: a comprehensive exploration of transcriptomic data and machine learning-based approaches.","authors":"Niyati Saini, Animesh Acharjee","doi":"10.1177/17562848251362391","DOIUrl":"10.1177/17562848251362391","url":null,"abstract":"<p><strong>Background: </strong>Inflammatory bowel disease (IBD), encompassing Crohn's disease (CD) and ulcerative colitis (UC), is a heterogeneous condition characterised by chronic gastrointestinal inflammation and dysregulated immune responses. Despite advances in transcriptomic analysis and machine learning (ML), consistent molecular subtyping across datasets remains a challenge. There is a critical need for robust subtypes that reflect disease heterogeneity and correlate with clinical outcomes.</p><p><strong>Objectives: </strong>Unlike prior studies focused on either UC or CD or based on small datasets, this study analyses a large-scale RNA sequencing (RNA-seq) dataset to identify transcriptomic subtypes in both UC and CD.</p><p><strong>Design: </strong>We analysed RNA-seq data from four prospective cross-sectional cohorts from Gene Expression Omnibus: GSE193677, GSE186507, GSE137344 and GSE235236.</p><p><strong>Methods: </strong>Analysed RNA-sequenced data from inflamed and non-inflamed intestinal biopsies of 2490 adult IBD patients. <i>K</i>-means clustering was applied independently to UC and CD samples to identify transcriptomic clusters. Gene set enrichment and network analyses explored molecular characteristics. Associations with clinical metadata, including disease severity and anatomical involvement, were assessed using Chi-square and analysis of variance tests.</p><p><strong>Results: </strong><i>K</i>-means clustering revealed three distinct transcriptomic subtypes in both UC and CD. In UC, Cluster 1 was enriched for RNA processing and DNA repair genes; Cluster 2 highlighted autophagy, stress responses and upregulation of <i>ATG13, VPS37C</i> and <i>DVL2</i>; Cluster 3 emphasised cytoskeletal organisation (<i>SRF, SRC</i> and <i>ABL1</i>). In CD, Cluster 1 featured cytoskeletal remodelling and suppressed protein synthesis (<i>CFL1, F11R</i> and <i>RAD23A</i>), while Cluster 2 upregulated stress and translation pathways. Cluster 3 again prioritised cytoskeletal structure over metabolic activity. Cluster 3 in both conditions was significantly associated with moderate-to-severe endoscopic activity; Cluster 1 was enriched in inactive or mild disease.</p><p><strong>Conclusion: </strong>We report three transcriptomic subtypes in UC and CD, each with distinct molecular signatures and clinical relevance. These findings support a stratified approach to IBD diagnosis and therapy, enabling more personalised disease management strategies.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251362391"},"PeriodicalIF":3.4,"publicationDate":"2025-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12344326/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144849372","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Contribution of the EyeMAX™ 11Fr (Micro-Tech) digital single-operator cholangioscope with a wide working channel: a multicenter pilot study on the first French experiences.","authors":"David Karsenti, Adrien Sportes, Sarah Leblanc, Stéphane Béchet, Jonathan Derman, Isaac Fassler, Bertrand Brieau","doi":"10.1177/17562848251360117","DOIUrl":"10.1177/17562848251360117","url":null,"abstract":"<p><strong>Background: </strong>Digital single-operator cholangioscopy (DSOC) enhances biliary stricture diagnosis, but the collection of quality samples can be difficult due to the small diameter of the working channel.</p><p><strong>Objectives: </strong>A new DSOC system (EyeMAX™ 11Fr; Micro-Tech Endoscopy, Nanjing, China) with a 2.0-mm working channel, accommodating pediatric forceps (1.6 mm), has been introduced in France. This study reports on the first French experience.</p><p><strong>Design: </strong>A retrospective, multicenter observational study.</p><p><strong>Methods: </strong>The study on DSOC was conducted across five endoscopy units within the French Society of Private Hepato-Gastroenterology (SFHGL-CREGG). Satisfaction and procedural evaluations were recorded using a visual analog scale (VAS) and compared with the Spyglass™ DS II (Boston Scientific, Marlborough, MA, USA).</p><p><strong>Results: </strong>Among 28 patients, 71.5% had undergone prior endoscopic sphincterotomy. Indications were biliary strictures in 26 patients and lithiasis in 2. Strictures were located in the bile duct (41%) or hilum (59%). The mean satisfaction score was 8.69 out of 10, with the EyeMAX 11Fr rated as superior to the SpyGlass DS II in 86% of cases. The mean biopsy count was 8.52 in 13.19 min, with 100% procedural success. Pathology specimens were rich (24%), adequate (52%), low (12%), or absent (12%). Sensitivity for cholangiocarcinoma was 73.7% (14/19). Benign strictures regressed in all cases. Procedure-related complications included pain twice (7.1%), fever once (3.6%), infection once (3.6%), and pancreatitis twice (7.1%), all of which were resolved rapidly.</p><p><strong>Conclusion: </strong>This first study on the EyeMAX 11Fr DSOC highlights its ease of use, superior biopsy facilitation, and high user satisfaction, achieving 73.7% sensitivity for cholangiocarcinoma diagnosis.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov ID: NCT06933576.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251360117"},"PeriodicalIF":3.4,"publicationDate":"2025-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12344333/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144849371","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Short- and longevity outcome of cyclosporin rescue therapy in severe ulcerative colitis refractory to intravenous corticosteroid treatment.","authors":"Bernadett Farkas, Peter Bacsur, Anita Bálint, Emese Ivány, Mariann Rutka, Anna Fábián, Zsófia Bősze, Renáta Bor, Zoltán Szepes, Klaudia Farkas, Tamás Molnár","doi":"10.1177/17562848251361054","DOIUrl":"10.1177/17562848251361054","url":null,"abstract":"<p><strong>Background: </strong>Many patients with severe ulcerative colitis (UC) fail to respond to first-line corticosteroids and require second-line rescue therapy with cyclosporin (CsA) to avoid colectomy.</p><p><strong>Objectives: </strong>To assess the short- and long-term effectiveness and safety of CsA therapy.</p><p><strong>Design: </strong>A single-center, retrospective study was conducted, including patients who received IV CsA therapy for severe, steroid-refractory UC.</p><p><strong>Methods: </strong>Data on therapeutic response and adverse events (AEs) were reported. The Kaplan-Meier method was used to estimate colectomy-free survival rates. The incidence of inflammatory bowel disease flare-ups and the use of advanced therapies after CsA discontinuation were also assessed. Regression analyses were performed to identify predictors for therapeutic response, colectomy, and AEs with CsA.</p><p><strong>Results: </strong>A total of 92 UC patients (54.4% male, mean age: 40.0 ± 14.0 years) were included with the median follow-up time of 14 years (IQR: 7-18). Clinical response was achieved in 88.0%, and clinical remission was observed in 23.9% of patients after the median 6-day (IQR: 7-5) IV phase. A total of 40.7% of responders experienced clinical remission, whereas 13.6% had endoscopic remission at the time of CsA withdrawal (median after 5 months of therapy). Patients receiving concomitant immunomodulators were more likely to achieve clinical remission with CsA (<i>p</i> = 0.002; OR: 6.4). After CsA discontinuation, 23.5% of patients relapsed within 6 months, while 59.3% of patients were started on biologics. The probability of colectomy-free survival was 74.7%, 62.6%, 57.1%, and 45.6% at 1, 3, 5, and 14 years after CsA initiation. AEs were reported in 53.3% of patients, mainly hyperlipidaemia, hypertension, and infections. Hypoalbuminaemia (<35 g/L) at treatment initiation increased the risk of AEs (<i>p</i> = 0.03; OR: 0.4), whereas the occurrence of AEs was not associated with concomitant immunomodulator use (<i>p</i> = 0.9).</p><p><strong>Conclusion: </strong>CsA may be a potent therapeutic option to induce remission in steroid-refractory, severely active UC, and its effectiveness may be enhanced by the concomitant use of immunomodulators, without compromising safety.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251361054"},"PeriodicalIF":3.4,"publicationDate":"2025-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12334824/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144818047","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}