BMJ Open Gastroenterology最新文献

{"title":"What is the role of out of programme clinical fellowships in the era of Shape of Training? A single-centre cohort study","authors":"Suneil A Raju, Freya J Bowker-Howell, Imran Aziz, Mo Thoufeeq, Alan J Lobo, Dermot C Gleeson, Amer Al-Joudeh, Mark E McAlindon, Andrew D Hopper, Sampath Kumar, Reena Sidhu, David S Sanders","doi":"10.1136/bmjgast-2023-001311","DOIUrl":"https://doi.org/10.1136/bmjgast-2023-001311","url":null,"abstract":"Background The updated Shape of Training curriculum has shortened the duration of specialty training. We present the potential role of out of programme clinical fellowships. Method An electronic online survey was sent to all current fellows to understand their experiences, training opportunities and motivations. Data were collected on fellows’ endoscopic experiences and publications using PubMed for all previous doctors who have completed the Sheffield Fellowship Programme. Results Since 2004, 39 doctors have completed the Sheffield Fellowship. Endoscopic experience: current fellows completed a median average of 350 (IQR 150–500) gastroscopies and 150 (IQR 106–251) colonoscopies per year. Fellows with special interests completed either 428 hepato-pancreato-biliary procedures or 70 endoscopic mucosal resections per year. Medline publications: Median average 9 publications(IQR 4–17). They have also received multiple national or international awards and 91% achieved a doctoral degree. The seven current fellows in the new Shape of Training era (57% male, 29% Caucasian, aged 31–40 years) report high levels of enjoyment due to their research projects, supervisory teams and social aspects. The most cited reasons for undertaking the fellowship were to develop a subspecialty interest, take time off the on-call rota and develop endoscopic skills. The most reported drawback was a reduced income. All current fellows feel that the fellowship has enhanced their clinical confidence and prepared them to become consultants. Conclusion Out of programme clinical fellowships offer the opportunity to develop the required training competencies, subspecialty expertise and research skills in a supportive environment. Data are available on reasonable request.","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140842002","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality of reporting inflammatory bowel disease randomised controlled trials: a systematic review","authors":"Morris Gordon, Jamal Khudr, Vassiliki Sinopoulou, Svetlana Lakunina, Aditi Rane, Anthony Akobeng","doi":"10.1136/bmjgast-2023-001337","DOIUrl":"https://doi.org/10.1136/bmjgast-2023-001337","url":null,"abstract":"Objective Our objective was to perform a systemic evaluation of the risk of bias in randomised controlled trial (RCT) reports published on inflammatory bowel disease (IBD). Design We assessed the risk of bias using the Cochrane tool, as indicators of poor methodology or subsequently poor reporting. We systematically selected, with dual independent judgements, all studies published on IBD with no time limits and assessed the methodological quality of included studies again using independent dual ratings. Results 563 full texts were included after selection and review. No abstract publications were free of any source of bias. Full-text publications still fared badly, as only 103 full-text papers exhibited a low risk of bias in all reporting domains when excluding blinding. RCTs published in journals with higher impact factor (IF) were associated with an overall reduced rate of being at high risk. However, only 6% of full RCT publications in journals with an IF greater than 10, published in the past 5 years, were free of bias. The trend over time is towards improved reporting in all areas. Trials published by larger author teams, in full-text form and by industry and public sponsorship were positively correlated with a lower risk of bias. Only allocation concealment showed a statistically significant improvement with time (p=0.037). Conclusion These findings are consistent with those of other specialties in the literature. While this unclear risk of bias may represent poor reporting of methods instead of poor methodological quality, it leaves readers and future secondary researchers with significant questions regarding such key issues. Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. The protocol for the review has been uploaded to a repository (Repository ID: 33117). Further methodological components and results are included in the appendix. Other data are available upon reasonable request.","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140611955","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and tolerability of OP-724 in patients with haemophilia and liver cirrhosis due to HIV/HCV coinfection: an investigator-initiated, open-label, non-randomised, single-centre, phase I study","authors":"Kiminori Kimura, Junko Tanuma, Masamichi Kimura, Jun Imamura, Mikio Yanase, Ichiro Ieiri, Masayuki Kurosaki, Tsunamasa Watanabe, Tomoyuki Endo, Hiroshi Yotsuyanagi, Hiroyuki Gatanaga","doi":"10.1136/bmjgast-2023-001341","DOIUrl":"https://doi.org/10.1136/bmjgast-2023-001341","url":null,"abstract":"Objective Patients with haemophilia and HIV who acquire hepatitis C virus (HCV) after receiving contaminated blood products can experience accelerated progression of liver fibrosis and a poor prognosis, making liver disease a prominent cause of mortality among these patients. In the current study, we aimed to evaluate the safety and tolerability of the potential antifibrotic agent OP-724—a CREB-binding protein/β-catenin inhibitor—in this patient subset. Design In this single-centre, open-label, non-randomised, phase I trial, we sequentially enrolled patients with cirrhosis following HIV/HCV coinfection classified as Child-Pugh (CP) class A or B. Five patients received an intravenous infusion of OP-724 at doses of 140 or 280 mg/m2 for 4 hours two times weekly over 12 weeks. The primary endpoint was the incidence of serious adverse events (SAEs). Secondary endpoints included the incidence of AEs and improved liver stiffness measure (LSM), as determined by vibration-controlled transient elastography. This study was registered at ClinicalTrials.gov ([NCT04688034][1]). Results Between 9 February 2021 and 5 July 2022, five patients (median age: 51 years) were enrolled. All five patients completed 12 cycles of treatment. SAEs were not observed. The most common AEs were fever (60%) and gastrointestinal symptoms (diarrhoea: 20%, enterocolitis: 20%). Improvements in LSM and serum albumin levels were also observed. Conclusion In this preliminary assessment, intravenous administration of 140 or 280 mg/m2/4 hours OP-724 over 12 weeks was well tolerated by patients with haemophilia combined with cirrhosis due to HIV/HCV coinfection. Hence, the antifibrotic effects of OP-724 warrant further assessment in patients with cirrhosis. Trial registration number [NCT04688034][1]. Data are available upon reasonable request. The anonymous data displayed in the manuscript will be made available on request from the corresponding author following the publication of this article. Data displayed in the manuscript or acquired during the clinical trial will be made available in a form that does not deviate from what is accepted by local regulatory authorities with respect to the handling of patient data and in adherence to the policies of the Tokyo Metropolitan Komagome Hospital. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04688034&atom=%2Fbmjgast%2F11%2F1%2Fe001341.atom","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140804872","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validity and reliability of the Persian version of the Gastroesophageal Reflux Disease Health-Related Quality of Life questionnaire","authors":"Seyed Ali Ebrahimi, Zahra Mostafavian, Elahe Karazhian, Fereshteh Najafi, Rasam Mashoufi, Tooraj Zandbaf, Elham Mokhtari","doi":"10.1136/bmjgast-2023-001298","DOIUrl":"https://doi.org/10.1136/bmjgast-2023-001298","url":null,"abstract":"Objective The Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) is one of the most widely used questionnaires for assessing typical gastro-oesophageal reflux disease (GORD) symptoms. It is simple, concise, and treatment responsive, yet it has not been validated in the Persian language. This study aimed to translate the GERD-HRQL questionnaire into Persian and assess its validity and reliability. Design In this cross-sectional validation study, a team of gastroenterologists, general surgeons, and professional translators conducted the forward-backward translation. A gastroenterologist interviewed 10 patients with GORD to insure understandability of the questionnaire. Fifty-four patients with GORD and 60 patients with gastrointestinal complaints other than GORD were enrolled using convenience sampling method. To assess concurrent validity, patients with GORD completed the Persian GERD-HRQL and the WHO Quality of Life Brief Version (WHOQOL-BREF) questionnaires. To assess discriminant validity, GERD-HRQL scores were compared between GORD and non-GORD patients. After 2 weeks, the patients with GORD completed the GERD-HRQL questionnaire again to assess test–retest reliability. The internal consistency was measured using Cronbach’s alpha. Results The mean age of the GORD participants was 36.90±10.44, and the majority were women (78%). All GERD-HRQL domains and total scores exhibited significant negative correlations with WHOQOL-BREF domains (ranging from −0.28 to −0.97). The GERD-HRQL scores were significantly different in GORD and non-GORD patients (p<0.001). Test and retest scores did not show any significant differences (p=0.49). Cronbach’s alpha was 0.85. Conclusion The Persian GERD-HRQL questionnaire is valid and reliable and can effectively assess the GORD symptoms in Persian-speaking individuals. Data are available upon reasonable request. Unnamed patient data are available upon request.","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140580443","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk of cancer in patients with bile acid diarrhoea: a Danish nationwide matched cohort study","authors":"Nynne Nyboe Andersen, Signe Wildt, Aske Thorn Iversen, Gry Poulsen, Tine Jess, Lars Kristian Munck, Christian Borup","doi":"10.1136/bmjgast-2023-001340","DOIUrl":"https://doi.org/10.1136/bmjgast-2023-001340","url":null,"abstract":"Objective Bile acid diarrhoea is a common cause of chronic diarrhoea. Increased levels of potentially carcinogenic bile acids in faeces, theoretically, may increase the risk of colorectal cancer in particular, but the long-term disease course is unknown. We aimed to investigate the overall and site-specific cancer risk in bile acid diarrhoea. Design Adult patients with bile acid diarrhoea were identified using nationwide Danish registries from 2003 to 2020 by a diagnostic gold-standard 75-selenium tauroselcholic acid procedure followed within 6 months by sequestrant prescription. The risk of overall and site-specific cancers in cases with bile acid diarrhoea was compared with sex, age and comorbidity-adjusted matched controls. A competing risk model estimated cumulative incidence functions and cause-specific HRs. Results We identified 2260 patients with bile acid diarrhoea with a mean follow-up of 5.5 years (SD 4.2). The overall cancer risk was increased by an HR of 1.32 (95% CI 1.12 to 1.54). The risk of site-specific cancer was increased in 3 of 10 cancer groups: haematological, HR 2.41 (1.36 to 4.02); skin, HR 1.33 (1.01 to 1.71); and male genital cancers, HR 1.85 (1.11 to 2.92). No increased risk of colorectal cancer was detected in patients with bile acid diarrhoea, HR 0.73 (0.34 to 1.63). Conclusions Bile acid diarrhoea was associated with an increased overall risk of cancer, especially haematological cancers, but the risk of colorectal cancer was not increased. The lack of a diagnostic code for bile acid diarrhoea and potential residual confounding are limitations, and the findings should be replicated in other cohorts. All data relevant to the study are included in the article or uploaded as supplemental information.","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140841197","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Retrograde tubing as a rescue treatment for megaoesophagus: a case report.","authors":"Chedva S Weiss, Jonathan Abraham Demma, Benjamin Koplewitz, Channa Maayan, Mordechai Slae","doi":"10.1136/bmjgast-2023-001285","DOIUrl":"10.1136/bmjgast-2023-001285","url":null,"abstract":"<p><p>Familial dysautonomia (FD) is a genetic disease of the autonomous and sensory nervous systems. Severe gastro-oesophageal reflux is common and one of the major complications. Some patients with FD develop megaoesophagus. Oesophageal malfunction, accompanied by oesophageal food and secretion retention, results in recurrent aspiration and other severe respiratory complications. Through a traditional case report, we wish to show how reverse tubing of the oesophagus can lead to significant symptomatic improvement in these patients. Moreover, this technique can serve as an alternative treatment for other oesophageal motility disorders.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10982896/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140304937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pruritus in primary biliary cholangitis is under-recorded in patient medical records.","authors":"Usha Gungabissoon, Helen T Smith, Robyn von Maltzahn, John Logie, Jolyon Fairburn-Beech, Liyuan Ma, Dhirishiya P, Ashleigh McGirr, Jake N Hunnicutt, Christopher L Rowe, Meghan Tierney, Haley S Friedler","doi":"10.1136/bmjgast-2023-001287","DOIUrl":"10.1136/bmjgast-2023-001287","url":null,"abstract":"<p><strong>Objective: </strong>Cholestatic pruritus in primary biliary cholangitis (PBC) reduces patients' health-related quality of life (HRQoL). Despite this, existing research suggests that pruritus is under-recorded in patients' health records. This study assessed the extent to which pruritus was recorded in medical records of patients with PBC as compared with patient-reported pruritus, and whether patients reporting mild itch were less likely to have pruritus recorded. We also evaluated clinico-demographic characteristics and HRQoL of patients with medical record-documented and patient-reported pruritus.</p><p><strong>Design: </strong>This cross-sectional study used clinical information abstracted from medical records, together with patient-reported (PBC-40) data from patients with PBC in the USA enrolled in the PicnicHealth cohort. Medical record-documented pruritus was classified as 'recent' (at, or within 12 months prior to, enrolment) or 'ever' (at, or any point prior to, enrolment). Patient-reported pruritus (4-week recall) was assessed using the first PBC-40 questionnaire completed on/after enrolment; pruritus severity was classified by itch domain score (any severity: ≥1; clinically significant itch: ≥7). Patient clinico-demographic characteristics and PBC-40 domain scores were described in patients with medical record-documented and patient-reported pruritus; overlap between groups was evaluated. Descriptive statistics were reported.</p><p><strong>Results: </strong>Pruritus of any severity was self-reported by 200/225 (88.9%) patients enrolled; however, only 88/225 (39.1%) had recent medical record-documented pruritus. Clinically significant pruritus was self-reported by 120/225 (53.3%) patients; of these, 64/120 (53.3%) had recent medical record-documented pruritus. Patients reporting clinically significant pruritus appeared to have higher mean scores across PBC-40 domains (indicating reduced HRQoL), versus patients with no/mild patient-reported pruritus or medical-record documented pruritus.</p><p><strong>Conclusion: </strong>Compared with patient-reported measures, pruritus in PBC is under-recorded in medical records and is associated with lower HRQoL. Research based only on medical records underestimates the true burden of pruritus, meaning physicians may be unaware of the extent and impact of pruritus, leading to potential undertreatment.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10982897/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140304936","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Online tools to predict individualised survival for primary oesophageal cancer patients with and without pathological complete response after neoadjuvant therapy followed by oesophagectomy: development and external validation of two independent nomograms.","authors":"Yuqin Cao, Binhao Huang, Han Tang, Dong Dong, Tianzheng Shen, Xiang Chen, Xijia Feng, Jiahao Zhang, Liqiang Shi, Chengqiang Li, Heng Jiao, Lijie Tan, Jie Zhang, Hecheng Li, Yajie Zhang","doi":"10.1136/bmjgast-2023-001253","DOIUrl":"10.1136/bmjgast-2023-001253","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to develop and validate robust predictive models for patients with oesophageal cancer who achieved a pathological complete response (pCR) and those who did not (non-pCR) after neoadjuvant therapy and oesophagectomy.</p><p><strong>Design: </strong>Clinicopathological data of 6517 primary oesophageal cancer patients who underwent neoadjuvant therapy and oesophagectomy were obtained from the National Cancer Database for the training cohort. An independent cohort of 444 Chinese patients served as the validation set. Two distinct multivariable Cox models of overall survival (OS) were constructed for pCR and non-pCR patients, respectively, and were presented using web-based dynamic nomograms (graphical representation of predicted OS based on the clinical characteristics that a patient could input into the website). The calibration plot, concordance index and decision curve analysis were employed to assess calibration, discrimination and clinical usefulness of the predictive models.</p><p><strong>Results: </strong>In total, 13 and 15 variables were used to predict OS for pCR and non-pCR patients undergoing neoadjuvant therapy followed by oesophagectomy, respectively. Key predictors included demographic characteristics, pretreatment clinical stage, surgical approach, pathological information and postoperative treatments. The predictive models for pCR and non-pCR patients demonstrated good calibration and clinical utility, with acceptable discrimination that surpassed that of the current tumour, node, metastases staging system.</p><p><strong>Conclusions: </strong>The web-based dynamic nomograms for pCR (https://predict-survival.shinyapps.io/pCR-eso/) and non-pCR patients (https://predict-survival.shinyapps.io/non-pCR-eso/) developed in this study can facilitate the calculation of OS probability for individual patients undergoing neoadjuvant therapy and radical oesophagectomy, aiding clinicians and patients in making personalised treatment decisions.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10982901/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140304935","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-term risk factors for developing Barrett's oesophagus in patients with gastro-oesophageal reflux disease: a longitudinal cohort study.","authors":"Christopher J Byrne, Paul Brennan, James Carberry, James Cotton, John F Dillon","doi":"10.1136/bmjgast-2023-001307","DOIUrl":"10.1136/bmjgast-2023-001307","url":null,"abstract":"<p><strong>Background and aims: </strong>Several characteristics are known to affect the risk of Barrett's oesophagus (BO) in the general population, with symptomatic gastro-oesophageal reflux disease (GORD) being a critical risk factor. In this study, we examined factors that influence BO development in people living with GORD.</p><p><strong>Design: </strong>People living with GORD were recruited from an endoscopy unit with lifestyle, medical and prescribing history collected. Logistic regression analysis was undertaken to assess the effects of multiple parameters on the likelihood of developing BO.</p><p><strong>Results: </strong>1197 participants were recruited. Most were Caucasian (n=1188, 99%), had no formal educational qualifications (n=714; 59.6%) and lived with overweight (mean body mass index >25 kg/m²). Many lived in areas of least socioeconomic resource (n=568; 47.4%). 139 (11.6%) had BO at baseline. In adjusted baseline analysis (n=1197), male sex (adjusted OR, aOR 2.04 (95% CI 1.92 to 4.12), p≤0.001), increasing age (aOR 1.03 (95% CI 1.01 to 1.04), p≤0.0001) and proton pump inhibitor use (aOR 3.03 (95% CI 1.80 to 5.13), p≤0.0001) were associated with higher odds of BO. At follow-up (n=363), 22 (6.1%) participants developed BO; male sex (aOR 3.18 (95% CI 1.28 to 7.86), p=0.012), pack-years cigarettes smoked (aOR 1.04 (95% CI 1.00 to 1.08), p=0.046) and increased alcohol intake (aOR 1.02 (95% CI 1.00 to 1.04), p=0.013), were associated with increased odds of BO.</p><p><strong>Conclusion: </strong>Male sex, pack-years cigarettes smoked, and increasing alcohol intake, were independently associated with increased odds of developing BO over 20-year follow-up. These results align with research linking male sex and smoking with BO and extend this by implicating the potential role of alcohol in developing BO, which may require communication through public health messaging.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10966788/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140189414","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Study protocol for a Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent-shunt in Acute Variceal Bleeding (REACT-AVB trial).","authors":"Dhiraj Tripathi, David Patch, Homoyon Mehrzad, Dominic Yu, Richard J Aspinall, Matthew J Armstrong, Adrian Stanley, Hamish Ireland, Simon Travis, Peter Hayes, Mandy Lomax, Nicholas Roslund, Emily Lam, Gemma Slinn, Sue Jowett, Catherine Moakes, Alisha Maher, Elizabeth Brettell, Sukhwant Sehmi","doi":"10.1136/bmjgast-2023-001314","DOIUrl":"10.1136/bmjgast-2023-001314","url":null,"abstract":"<p><strong>Introduction: </strong>In liver cirrhosis, acute variceal bleeding (AVB) is associated with a 1-year mortality rate of up to 40%. Data on early or pre-emptive transjugular intrahepatic portosystemic stent-shunt (TIPSS) in AVB is inconclusive and may not reflect current management strategies. Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent-shunt in AVB (REACT-AVB) aims to investigate the clinical and cost-effectiveness of early TIPSS in patients with cirrhosis and AVB after initial bleeding control.</p><p><strong>Methods and analysis: </strong>REACT-AVB is a multicentre, randomised controlled, open-label, superiority, two-arm, parallel-group trial with an internal pilot. The two interventions allocated randomly 1:1 are early TIPSS within 4 days of diagnostic endoscopy or secondary prophylaxis with endoscopic therapy in combination with non-selective beta blockers. Patients aged ≥18 years with cirrhosis and Child-Pugh Score 7-13 presenting with AVB with endoscopic haemostasis are eligible for inclusion. The primary outcome is transplant-free survival at 1 year post randomisation. Secondary endpoints include transplant-free survival at 6 weeks, rebleeding, serious adverse events, other complications of cirrhosis, Child-Pugh and Model For End-Stage Liver Disease (MELD) scores at 6 and 12 months, health-related quality of life, use of healthcare resources, cost-effectiveness and use of cross-over therapies. The sample size is 294 patients over a 4-year recruitment period, across 30 hospitals in the UK.</p><p><strong>Ethics and dissemination: </strong>Research ethics committee of National Health Service has approved REACT-AVB (reference number: 23/WM/0085). The results will be submitted for publication in a peer-reviewed journal. A lay summary will also be emailed or posted to participants before publication.</p><p><strong>Trial registration number: </strong>ISRCTN85274829; protocol version 3.0, 1 July 2023.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10966777/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140189415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}