Khawla Abu Hammour, Adnan Abu Hamour, Faris El-Dahiyat, Mohammed Zawiah, Rana K Abu-Farha
{"title":"A systematic review of vedolizumab in treating pediatric ulcerative colitis: efficacy and safety insights.","authors":"Khawla Abu Hammour, Adnan Abu Hamour, Faris El-Dahiyat, Mohammed Zawiah, Rana K Abu-Farha","doi":"10.1177/17562848251356063","DOIUrl":"10.1177/17562848251356063","url":null,"abstract":"<p><strong>Background: </strong>Ulcerative colitis (UC) in pediatric patients often results in corticosteroid (CS) dependency, with many individuals developing resistance to conventional treatments such as anti-TNF agents. Vedolizumab, a monoclonal antibody targeting α4β7 integrin, has shown promise in adult populations, but data on its efficacy and safety in children and adolescents are limited.</p><p><strong>Objectives: </strong>This systematic review aims to assess the effectiveness and safety of vedolizumab in treating UC in pediatric patients.</p><p><strong>Design data sources and methods: </strong>The PRISMA statement's guidelines were followed in conducting this systematic review. Up until December 2024, a thorough search was carried out using keywords associated with inflammatory bowel disease (IBD), vedolizumab, and pediatric populations in the Cochrane Library, EMBASE, and PubMed. Case series of children and adolescents (less than 18 years old) with UC or unclassified IBD who were treated with vedolizumab were included in the research. Data on clinical response, mucosal healing, corticosteroid-free remission, clinical remission, and adverse events were extracted. Descriptive statistics were used in the statistical analysis.</p><p><strong>Results: </strong>A total of 14 papers were considered in the current evaluation of the effectiveness and safety of vedolizumab. Nearly one-third (36%) of patients with UC/IBD-U experienced clinical remission at 6 weeks, half of the patients at 14 weeks (50%), and 48% and 53% of patients at 22 weeks, respectively. Forty-five percent of patients maintained clinical remission after 1 year. Less than 8% of UC/IBD-U patients experienced serious side effects, while 15%-34% of patients experienced mucosal healing.</p><p><strong>Conclusion: </strong>Vedolizumab exhibits promising efficacy and a favorable safety profile in treating pediatric UC, with a sizable portion of patients achieving both clinical and corticosteroid-free remission. However, due to the limited sample sizes and lack of investigations, more randomized controlled trials and long-term research are needed to confirm these findings and develop more reliable clinical guidelines for its use in children and adolescents with UC. This means that even if the initial findings are promising, additional and better testing is required to ensure that vedolizumab is both effective and safe for young patients with UC.</p><p><strong>Trial registration: </strong>The PROSPERO registration number for this systematic review is CRD420250651513.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251356063"},"PeriodicalIF":3.4,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12290360/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144734360","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":"Cholecystectomy and the risk of microscopic colitis: a systematic review and meta-analysis.","authors":"Zhaoxu Tian, Hongying Tang, Guoming Sun, Jianjun Shen, Yangri Duan, Hangbin Jin","doi":"10.1177/17562848251357067","DOIUrl":"10.1177/17562848251357067","url":null,"abstract":"<p><strong>Background: </strong>Several observational studies suggest a potential association between cholecystectomy and the risk of developing microscopic colitis (MC). However, the current findings remain inconsistent.</p><p><strong>Objectives: </strong>To address this discrepancy, we conducted a systematic review and meta-analysis to comprehensively assess the association between cholecystectomy and the risk of MC.</p><p><strong>Design: </strong>Systematic review and meta-analysis.</p><p><strong>Data sources and methods: </strong>A systematic search of PubMed, Embase, and Web of Science was conducted to identify studies evaluating the association between cholecystectomy and MC risk. Studies were eligible if they reported effect estimates or provided sufficient data for calculation. Two independent authors extracted the data and assessed the quality of included studies. A random-effects model was used to pool odds ratios (ORs), with subgroup analyses performed according to patient characteristics and study quality.</p><p><strong>Results: </strong>Six observational studies were included in the final analysis. The pooled OR was 0.80 (95% confidence interval: 0.52-1.22), and sensitivity analysis confirmed the robustness of the results, indicating no significant association between cholecystectomy and MC risk. Subgroup analyses based on geographic location, study design, study quality, methods of cholecystectomy data collection, control populations, and MC subtypes consistently showed no significant association.</p><p><strong>Conclusion: </strong>Current evidence suggests no statistically significant association between cholecystectomy and the risk of MC. Future research should include populations with diverse geographic and ethnic backgrounds, utilize medical records for accurate surgical history, and account for potential confounding factors. Large-scale prospective studies will be essential to obtain more reliable and definitive conclusions.</p><p><strong>Trial prospero registration: </strong>CRD42024592056.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251357067"},"PeriodicalIF":3.4,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12290341/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144734362","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}
Cathy Guo, Julia Fox, Kristie Bell, Danielle Gallegos, Lynda J Ross
{"title":"Whole-food diet therapies for children with Crohn's disease: a systematic review.","authors":"Cathy Guo, Julia Fox, Kristie Bell, Danielle Gallegos, Lynda J Ross","doi":"10.1177/17562848251355436","DOIUrl":"10.1177/17562848251355436","url":null,"abstract":"<p><strong>Background: </strong>Children with Crohn's disease (CD) experience gastrointestinal symptoms that impair nutrition, growth and quality of life. Exclusive enteral nutrition is recommended as a first-line remission induction treatment. However, compliance is challenging due to monotony and the social impact of excluding whole foods, increasing interest in whole-food diet therapies.</p><p><strong>Objectives: </strong>This systematic review aimed to summarise current evidence regarding the impact of whole-food therapies on clinical remission (as defined by each study using validated measures) and related health outcomes in children with CD.</p><p><strong>Design: </strong>We performed a systematic review of studies assessing whole-food interventions in children with CD.</p><p><strong>Data sources and methods: </strong>A systematic search was conducted in electronic databases for research published in English from 1 January 2012 to 16 August 2024. Randomised controlled trials (RCTs), quasi-experimental studies, cohort studies, case-control studies and case series were included.</p><p><strong>Results: </strong>Twenty-eight studies (<i>n</i> = 4 RCTs, <i>n</i> = 3 non-RCTs, <i>n</i> = 16 observational studies, <i>n</i> = 5 post hoc analyses) met inclusion criteria and examined six types of diets. Most of the children being treated had uncomplicated, mild-moderate disease activity and were on concomitant medications. Those on whole-food therapies demonstrated a median clinical remission rate of 75% (interquartile range 62%-85%; <i>n</i> = 18 studies), mucosal improvement and healing (<i>n</i> = 5/6 studies), improved inflammatory biomarkers (<i>n</i> = 18/19 studies) and enhanced growth parameters (<i>n</i> = 11/13 studies). Outcomes related to microbial changes were inconsistent. Overall, studies were low-medium quality due to small, non-randomised, uncontrolled studies using a variety of concomitant medications and different definitions for clinical remission, preventing definitive conclusions.</p><p><strong>Conclusion: </strong>The findings suggest whole-food diet therapies can potentially be used to treat children with mild to moderate CD and that a flexible, nutrient-balanced dietary approach tailored to the individual child may be possible. However, large-scale, RCTs with standardised outcome measures are needed to further support the routine use of whole-food therapies in paediatric CD.</p><p><strong>Trial registration: </strong>PROSPERO registration number CRD42024580134.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251355436"},"PeriodicalIF":3.4,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12290382/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144734364","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 in inflammatory bowel disease: innovations in diagnosis, monitoring, and personalized care.","authors":"Raseen Tariq, Anita Afzali","doi":"10.1177/17562848251357407","DOIUrl":"10.1177/17562848251357407","url":null,"abstract":"<p><p>Artificial intelligence (AI) is redefining the management of inflammatory bowel diseases (IBD) by enhancing diagnostic accuracy, refining disease classification, and optimizing disease monitoring. This review highlights AI's potential to transform IBD management by streamlining clinical workflows, improving diagnostic precision, and supporting personalized treatment strategies. By addressing the limitations of traditional clinical assessments including variability, subjectivity, and resource intensity, AI offers unbiased, consistent, and efficient solutions. Concluding with a forward-looking perspective, this paper emphasizes how integrating AI into clinical practice could lead to more precise, proactive, and patient-centric approaches to IBD care, ultimately enhancing clinical outcomes and quality of life for these patients.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251357407"},"PeriodicalIF":3.4,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12290379/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144734361","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":"Observable score for bleeding after colorectal endoscopic mucosal resection.","authors":"Hayato Nakazawa, Kenichiro Okimoto, Tomoaki Matsumura, Masayuki Yokoyama, Tsubasa Ishikawa, Yoshihiro Fukuda, Yoshio Kitsukawa, Akane Kurosugi, Michiko Sonoda, Tatsuya Kaneko, Yuki Ohta, Takashi Taida, Keisuke Matsusaka, Jun-Ichiro Ikeda, Jun Kato","doi":"10.1177/17562848251356112","DOIUrl":"10.1177/17562848251356112","url":null,"abstract":"<p><strong>Background: </strong>There is insufficient evidence regarding the management of hematochezia after colorectal endoscopic mucosal resection (EMR) without endoscopic hemostasis.</p><p><strong>Objectives: </strong>The aim of this study was to develop an observable score for hematochezia after colorectal EMR.</p><p><strong>Design: </strong>Retrospective study.</p><p><strong>Methods: </strong>This retrospective study included three hospitals in Japan. During the study period, colorectal EMR was performed in 3989 patients (11,414 lesions). Post-EMR hematochezia (delayed bleeding (DB)) was observed in 169 patients (512 lesions). Of these, 47 patients (150 lesions) were classified into the Hemostasis Group, comprising those who underwent endoscopic hemostasis. The remaining 122 (362 lesions) were classified into the non-hemostasis group, comprising those who underwent endoscopy without hemostasis, received preventive hemostasis, and did not undergo emergency endoscopy. Weighted points were assigned to predict observable cases following colorectal EMR through multivariate logistic regression analysis, enabling the development of a predictive model.</p><p><strong>Results: </strong>The prediction model comprised three variables (male gender, American Society of Anesthesiologists Physical Status 3, direct oral anticoagulant). According to the definition, the total score was categorized as lowly observable (2 or 3 points) and highly observable (0 or 1 points) for DB after colorectal EMR. As a result, the rates of observable cases for each risk category were 45.7% and 81.8%, respectively. The model showed good discrimination ability from the c-statistic (95% CI) of 0.71 (0.63-0.79).</p><p><strong>Conclusion: </strong>Although further prospective studies are necessary to validate the utility of the score, it may be useful in clinical practice.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251356112"},"PeriodicalIF":3.9,"publicationDate":"2025-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12280549/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144692123","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}
Linda Ryen, Isabella Visuri, Sara Karlqvist, Carolina Malmgren, Daniel Bergemalm, Carl Eriksson
{"title":"Healthcare resource utilization and production loss in vedolizumab-treated inflammatory bowel disease patients: results from the Swedish prospective multicentre SVEAH study.","authors":"Linda Ryen, Isabella Visuri, Sara Karlqvist, Carolina Malmgren, Daniel Bergemalm, Carl Eriksson","doi":"10.1177/17562848251352023","DOIUrl":"10.1177/17562848251352023","url":null,"abstract":"<p><strong>Background: </strong>Data on direct and indirect annual costs for inflammatory bowel disease (IBD) patients treated with vedolizumab are limited.</p><p><strong>Objectives: </strong>To evaluate the total annual direct healthcare costs and indirect costs among IBD patients treated with vedolizumab.</p><p><strong>Design: </strong>A prospective observational multicentre study involving 286 patients with Crohn's disease (CD; <i>n</i> = 169) or ulcerative colitis (UC; <i>n</i> = 117) who started vedolizumab therapy during 2015-2017 at 21 hospitals across Sweden.</p><p><strong>Methods: </strong>Data on direct and indirect costs were collected during a 3-year follow-up period. Direct costs were measured as healthcare resource utilization including medication, hospital admissions and hospital-based outpatient visits. Indirect societal costs were measured as production losses from sick leave and disability pension. Data were obtained from the Swedish Quality Register for IBD and through linkage with national registers. Data are presented both for patients who continued treatment throughout the follow-up period and for patients who discontinued treatment (CD: <i>n</i> = 83; UC: <i>n</i> = 48).</p><p><strong>Results: </strong>The mean annual direct follow-up cost was €24,305 for all IBD patients, €24,873 for CD patients and €23,484 for UC patients (<i>p</i> = 0.24). No difference was observed between men and women (€24,506 vs €24,080; <i>p</i> = 0.87). Direct costs were similar in patients who continued vedolizumab for the entire study period (€24,401) and those who discontinued treatment (€24,192; <i>p</i> = 0.12). Medication was the primary driver of direct costs (64%), followed by hospital admissions (19%) and outpatient care (17%). Mean indirect costs were lower among patients who continued vedolizumab (€3044) than among those who stopped the treatment (€8927; <i>p</i> < 0.01). Increased direct costs were associated with perianal disease and high baseline disease activity in CD, and concurrent use of immunomodulators in UC.</p><p><strong>Conclusion: </strong>Patients treated with vedolizumab in Swedish clinical practice represent a group with high direct costs, primarily due to medication expenses. However, indirect costs were significantly lower than in previous reports.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251352023"},"PeriodicalIF":3.4,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12290438/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144734363","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}
Min Jeong Je, Jeong Min Go, Shin Yeong Kim, Min-Gul Kim, Hankil Lee, Ha-Lim Jeon, Jae Hyun Kim
{"title":"Prescription trends of gastric acid suppressants and association with potential adverse events in Korea: a real-world cross-sectional study.","authors":"Min Jeong Je, Jeong Min Go, Shin Yeong Kim, Min-Gul Kim, Hankil Lee, Ha-Lim Jeon, Jae Hyun Kim","doi":"10.1177/17562848251356406","DOIUrl":"10.1177/17562848251356406","url":null,"abstract":"<p><strong>Background: </strong>Recent changes in the acid-related disease market, particularly the emergence of potassium-competitive acid blockers (P-CABs), require an updated analysis of trends in gastric acid suppressant utilization.</p><p><strong>Objectives: </strong>As the use of P-CAB expands globally, a cross-sectional study is needed to assess its association with potential adverse events from a pharmacovigilance perspective.</p><p><strong>Design: </strong>Cross-sectional study.</p><p><strong>Methods: </strong>We analyzed gastric acid suppressant use at prescription and patient levels using the Health Insurance Review and Assessment National Patient Sample database (2014-2020). Prescription-level analysis included the annual prescriptions for histamine-2 receptor antagonists (H2RAs), proton pump inhibitors (PPIs), and P-CABs, and proportion of visits by acid-related indications. Patient-level analysis examined annual trends in drug use and clinical characteristics. Logistic regression was used to estimate prevalence odds ratios (ORs) for potential adverse events among drug users and non-users according to the drug class.</p><p><strong>Results: </strong>In 2020, H2RAs were primarily prescribed for gastritis and duodenitis (64.5%), whereas PPIs (55.4%) and P-CABs (58.6%) were primarily used to treat gastroesophageal reflux disease. H2RA prescriptions declined in 2019, whereas the use of P-CAB increased following the approval of tegoprazan in 2018. Patients aged 40-64 years and female users were predominant across all classes of gastric acid suppressants. P-CAB use was significantly associated with osteoporosis (OR = 1.17; 95% confidence interval (CI): 1.13-1.20), pneumonia (OR = 1.65, 95% CI: 1.55-1.75), and acute kidney injury (OR = 1.39, 95% CI: 1.20-1.61).</p><p><strong>Conclusion: </strong>P-CABs have reshaped the prescription landscape of gastric acid suppressants. Further longitudinal cohort studies are required to evaluate long-term safety in routine clinical practice.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251356406"},"PeriodicalIF":3.9,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12264408/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144650983","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}
Takeshi Ogura, Saori Ueno, Akitoshi Hakoda, Atsushi Okuda, Nobu Nishioka, Jun Sakamoto, Jun Matsuno, Yuki Uba, Mitsuki Tomita, Nobuhiro Hattori, Junichi Nakamura, Kimi Bessho, Taro Iwatsubo, Ahmad F Aboelezz, Hiroki Nishikawa
{"title":"Clinical impact of recombinant thrombomodulin administration on disseminated intravascular coagulation due to severe acute pancreatitis (Recover-AP study).","authors":"Takeshi Ogura, Saori Ueno, Akitoshi Hakoda, Atsushi Okuda, Nobu Nishioka, Jun Sakamoto, Jun Matsuno, Yuki Uba, Mitsuki Tomita, Nobuhiro Hattori, Junichi Nakamura, Kimi Bessho, Taro Iwatsubo, Ahmad F Aboelezz, Hiroki Nishikawa","doi":"10.1177/17562848251353626","DOIUrl":"10.1177/17562848251353626","url":null,"abstract":"<p><strong>Background: </strong>If severe acute pancreatitis (SAP) is complicated by disseminated intravascular coagulation (DIC) or walled-off necrosis (WON), the mortality rate may increase. Therefore, prevention of the development of WON and treatment of DIC are likely to play important roles in improving survival in SAP. Although recombinant human soluble thrombomodulin (rhTM) might play a useful role in treating DIC, the impact of rhTM on improving survival and resolution of DIC due to SAP is still unclear.</p><p><strong>Objective: </strong>This study aimed to evaluate the clinical impact of rhTM in patients with SAP and DIC.</p><p><strong>Design: </strong>A single-center retrospective study.</p><p><strong>Method: </strong>The patients were divided into two groups: the rhTM group and the non-rhTM group, in which rhTM was not administered. The primary outcome was the DIC resolution rate at 7 days after starting treatment. The mortality rate at 28 days was secondarily evaluated.</p><p><strong>Results: </strong>Among 321 SAP patients, 63 patients were complicated with DIC, and they were divided into rhTM (<i>n</i> = 28) and non-rhTM (<i>n</i> = 35) groups. The rate of development of WON was significantly higher in the non-rhTM group (51.4%, 18/35) compared with the rhTM group (25.0%, 7/28) (<i>p</i> = 0.033). The resolution rate of DIC within 7 days was significantly higher in the rhTM group (89.3%, 25/28) compared with the non-rhTM group (60.0%, <i>n</i> = 9/35) (<i>p</i> = 0.009). The mortality rate within 14 days, which might have been strongly influenced by the presence of DIC, was significantly higher in the non-rhTM group (20.0%, 7/35) compared with the rhTM group (0%, 0/28) (<i>p</i> = 0.01). According to multivariate analysis, rTM non-administration was an independent factor for failed DIC resolution or developing WON.</p><p><strong>Conclusion: </strong>In conclusion, rhTM may play a role not only in improving the resolution rate of DIC and improving the survival rate of SAP, but also in preventing the development of WON.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251353626"},"PeriodicalIF":3.9,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12264407/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144650982","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":"Clinical outcomes of endoscopic ultrasound-guided hepaticogastrostomy-based internal drainage for unresectable malignant hilar biliary obstruction: a comprehensive evaluation with malignant distal biliary obstruction.","authors":"Daiki Yamashige, Susumu Hijioka, Yoshikuni Nagashio, Shota Harai, Yasuhiro Komori, Aoi Kita, Masaru Kuwada, Soma Fukuda, Shin Yagi, Kohei Okamoto, Daiki Agarie, Shunsuke Sugawara, Miyuki Sone, Yutaka Saito, Takuji Okusaka","doi":"10.1177/17562848251356099","DOIUrl":"10.1177/17562848251356099","url":null,"abstract":"<p><strong>Background: </strong>Endoscopic retrograde cholangiopancreatography (ERCP) may not provide adequate drainage for patients with malignant hilar biliary obstruction (MHBO). Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) is a salvage method for malignant distal biliary obstruction (MDBO); however, its effectiveness for MHBO remains unclear.</p><p><strong>Objectives: </strong>We aimed to evaluate the short- and long-term outcomes of EUS-HGS for MHBO.</p><p><strong>Design: </strong>This was a single-center retrospective cohort study.</p><p><strong>Methods: </strong>Unresectable patients who underwent initial EUS-HGS because of ERCP failure were recruited. Distal biliary stenosis or Bismuth types I and II-IV were defined as MDBO and MHBO, respectively. We defined EUS-HGS for MDBO as the control and analyzed the outcomes for MHBO.</p><p><strong>Results: </strong>The MDBO group (<i>n</i> = 208) was treated using EUS-HGS alone. In the MHBO group (<i>n</i> = 63), EUS-HGS alone (unilateral drainage, <i>n</i> = 26), EUS-HGS with bridging (EUS-HGSB, bilateral drainage, <i>n</i> = 21), and ERCP + EUS-HGS (bilateral drainage, <i>n</i> = 16) were performed. In EUS-HGS (MDBO), EUS-HGS (MHBO), EUS-HGSB, and ERCP + EUS-HGS, the technical success rates were 98.6%, 96.3%, 95.5%, and 94.1%; clinical success rates were 88.5%, 76.9%, 85.7%, and 75.0%; adverse event rates were 19.7%, 15.4%, 9.5%, and 25.0%; and non-recurrent biliary obstruction (RBO) rates at 180 days were 45.5%, 19.8%, 61.9%, and 68.4%, respectively. In multivariate analysis of the MHBO group, EUS-HGSB tended to have a lower risk of RBO (adjusted hazard ratio (aHR), 0.39; <i>p</i> = 0.09), and ERCP + EUS-HGS showed a significantly lower risk (aHR, 0.25; <i>p</i> = 0.03) compared to EUS-HGS alone (unilateral drainage).</p><p><strong>Conclusion: </strong>ERCP + EUS-HGS followed by EUS-HGSB, providing bilateral drainage, can offer preferred palliation for MHBO. These drainages may serve as potential salvage options in the management of MHBO.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251356099"},"PeriodicalIF":3.9,"publicationDate":"2025-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12256750/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144638480","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}
Jin-Yan Zhang, Jin-Hai Chen, Yu-Lin Huang, Ji Li, Dong Xu, Zhong Xu, Xiao-Yi Lei
{"title":"Fourteen-day vonoprazan-amoxicillin dual therapy versus 14-day bismuth-based quadruple therapy for <i>Helicobacter pylori</i> treatment: a randomized clinical trial.","authors":"Jin-Yan Zhang, Jin-Hai Chen, Yu-Lin Huang, Ji Li, Dong Xu, Zhong Xu, Xiao-Yi Lei","doi":"10.1177/17562848251354868","DOIUrl":"10.1177/17562848251354868","url":null,"abstract":"<p><strong>Background: </strong>Potassium-competitive acid blockers (P-CABs) have shown potential in <i>Helicobacter pylori</i> (<i>H. pylori</i>) eradication, but the efficacy of dual therapy with P-CABs and amoxicillin remains underexplored.</p><p><strong>Objectives: </strong>This study evaluated the efficacy, safety, and compliance of a 14-day vonoprazan-amoxicillin (VA) dual therapy compared to a bismuth-based quadruple therapy (BQT) in treatment-naive patients.</p><p><strong>Design: </strong>A randomized clinical trial.</p><p><strong>Methods: </strong>This single-center, prospective, randomized controlled trial enrolled 250 <i>H. pylori</i>-positive patients from November 2022 to April 2024. Participants were randomly assigned (1:1) to receive 14-day VA dual therapy or BQT (lansoprazole, bismuth, amoxicillin, and clarithromycin). The primary outcomes were eradication rates in intention-to-treat (ITT) and per-protocol (PP) analyses. Secondary outcomes included adverse events and treatment compliance.</p><p><strong>Results: </strong>Eradication rates in the ITT analysis were 92.0% for the VA dual group and 88.0% for the BQT group (<i>p</i> = 0.292). In the PP analysis, eradication rates were 95.8% and 91.7%, respectively (<i>p</i> = 0.188). The VA dual group demonstrated statistically significant non-inferiority to the BQT group in both the ITT and PP analyses (both <i>p</i> < 0.001). The incidence of adverse events was significantly lower in the VA dual group compared to the BQT group (11.2% vs 20.8%, <i>p</i> = 0.038), with no severe adverse events reported. The compliance rates of both groups were 97.6%.</p><p><strong>Conclusion: </strong>The 14-day VA dual therapy is highly effective and well-tolerated, demonstrating non-inferiority to BQT. Given its reduced antibiotic usage and lower adverse events, it may be a viable first-line alternative for <i>H. pylori</i> in southern China.</p><p><strong>Trial registration: </strong>This trial was registered on the Chinese Clinical Trial Registry with the registration number ChiCTR2200055752.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251354868"},"PeriodicalIF":3.9,"publicationDate":"2025-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12256727/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144638419","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}