{"title":"Assessing water-assisted colonoscopy in beginner endoscopists: a randomised controlled trial.","authors":"Nuttida Manoros, Nithi Thinrungroj, Wasuwit Wanchaitanawong, Kanokwan Pinyopornpanish, Phuripong Kijdamrongthum, Apinya Leerapun, Taned Chitapanarux, Satawat Thongsawat, Ong-Ard Praisontarangkul","doi":"10.1136/bmjgast-2024-001561","DOIUrl":"10.1136/bmjgast-2024-001561","url":null,"abstract":"<p><strong>Objective: </strong>To compare water-assisted colonoscopy (WAC) using the water immersion technique with conventional carbon dioxide insufflation colonoscopy (CC) in novice endoscopists, focusing on procedure time, safety and learning curves.</p><p><strong>Methods: </strong>We conducted a prospective, randomised (1:1), single-centre trial at Chiang Mai University Hospital, Thailand. Six gastroenterology fellows with <150 prior colonoscopies received standardised training before performing elective screening colonoscopies using either WAC or CC techniques. Patients were randomly assigned to WAC or CC groups. The primary outcome was caecal intubation time (CIT). Secondary outcomes included technical failure, procedural difficulty, patient discomfort, complications, withdrawal time and adenoma detection rate (ADR).</p><p><strong>Results: </strong>Of 250 randomised patients, 230 completed the protocol (WAC, n=113; CC, n=117). Mean CIT was comparable between groups (10.6±4.2 min vs 9.8±3.9 min; p=0.35). Technical failure occurred in 6.2% of WAC and 5.1% of CC procedures, with no significant differences in procedural difficulty ratings, analgesic requirements or patient discomfort scores. ADR was similar between arms (40.7% vs 33.3%; p=0.25). Learning curves demonstrated parallel, progressive reductions in CIT among fellows in both groups.</p><p><strong>Conclusion: </strong>WAC is a safe and effective alternative to CC for novice endoscopists, with similar procedure times, learning curves and safety profiles. These findings support the inclusion of WAC in gastroenterology training programmes.</p><p><strong>Trial registration number: </strong>TCTR20230324001.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"12 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144141135","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":"Ending nuclear weapons, before they end us.","authors":"Chris Zielinski","doi":"10.1136/bmjgast-2025-001891","DOIUrl":"10.1136/bmjgast-2025-001891","url":null,"abstract":"","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"12 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083279/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076102","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":"Akita Japan population-based colonoscopy screening trial: report of initial colonoscopy.","authors":"Shin-Ei Kudo, Noriaki Takahashi, Kenta Kodama, Fumio Ishida, Hiro-O Yamano, Seiichiro Yamamoto, Koichi Nagata, Kunihiko Wakamura, Hiro-O Matsushita, Nobuo Hiwatashi, Takahisa Matsuda, Hiroshi Saito","doi":"10.1136/bmjgast-2024-001715","DOIUrl":"10.1136/bmjgast-2024-001715","url":null,"abstract":"<p><strong>Objective: </strong>To assess the safety and quality of baseline screening colonoscopy in a randomised controlled trial (RCT).</p><p><strong>Methods: </strong>A population-based RCT with an explanatory design is ongoing to evaluate the efficacy of colonoscopy screening in 9751 men and women aged 40-74 years at average risk of colorectal cancer (CRC) in Japan. Screening colonoscopies for the intervention group were performed from June 2009 to June 2017.</p><p><strong>Results: </strong>Of the 4861 participants in the intervention group, 4495 (92.5%) underwent screening colonoscopy. The quality of bowel preparation was excellent (34.8%) or good (45.6%) in 80.4% of cases. The caecal intubation rate was 99.7% (4483/4495), and the mean (±SD) withdrawal time was 9.7 (±5.3) min. The adenoma detection rate (ADR) was 39.4% (1770/4495). A total of 27 participants (0.6%) were diagnosed with CRC, and 266 (5.9%) were diagnosed with advanced neoplasia (AN). In women, adenomas were more frequently detected in the proximal colon than in the distal colon (proximal: 18.9% vs distal: 16.4%, p=0.024), and a similar trend was observed for AN (proximal: 2.4% vs distal: 1.5%, p=0.045). No serious adverse events related to screening colonoscopy were reported, and minor adverse events were observed in two participants (0.04%).</p><p><strong>Conclusions: </strong>Adequate performance in compliance, ADR, and safety was confirmed in the intervention arm of the RCT evaluating the efficacy of screening colonoscopy. The high quality of screening colonoscopy observed in the trial suggests its feasibility as a population-based screening approach.</p><p><strong>Trial registration number: </strong>UMIN000001980.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"12 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083350/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076100","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":"Evaluating the cost-effectiveness of replacing lansoprazole with vonoprazan for treating erosive oesophagitis.","authors":"Saeash Jeyarajan, Thejasvin K, Sneha Pimpalnerkar, Emily Zichu Deng, Zain Ahmad, Diya Banerjee, Laure de Preux","doi":"10.1136/bmjgast-2024-001709","DOIUrl":"10.1136/bmjgast-2024-001709","url":null,"abstract":"<p><strong>Objective: </strong>This cost-effectiveness analysis compares vonoprazan against lansoprazole, a gold-standard proton pump inhibitor, in managing erosive oesophagitis.</p><p><strong>Methods: </strong>The economic evaluation was carried out using data from a double-blind, randomised control trial. Costs were measured in pounds sterling. Effectiveness was assessed on a binary scale, resolution versus non-resolution of disease, after 32 weeks.</p><p><strong>Results: </strong>The primary analysis produced an incremental cost-effectiveness ratio (ICER) of £3421.27 per resolution. After applying quality-adjusted life year (QALY) data from the REFLUX trial (2008), we derived an ICER/QALY of £34 747.32, marginally exceeding the £30 000 threshold set by the National Institute for Health and Care Excellence. However, further subgroup analysis showed cost-effectiveness when healing severe grades of oesophagitis (ICER/QALY of £22 165.56). The first sensitivity analysis considers the typically non-invasive determination of disease resolution; the ICER/QALY of £15 826.98 supports vonoprazan's use in treating severe oesophagitis. The second considers a longer healing phase alongside a stronger 30 mg maintenance dose of lansoprazole, concordant with current guidelines; the ICER/QALY of £43 998.39 suggests the guidelines (regarding dosage, frequency and duration) must be optimised for vonoprazan. The final sensitivity analysis accounts for variations in quality-of-life measures, which grossly inflate the ICER/QALY (£118 216.32); this emphasises that vonoprazan should mainly be considered for patients with persistent symptoms and high severity.</p><p><strong>Conclusion: </strong>Vonoprazan is potentially cost-effective for the initial healing of severe oesophagitis, after endoscopic diagnosis. Further trials and economic evaluations are necessary for the symptom-based prescription of vonoprazan and to determine the optimal dosage, frequency and duration.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"12 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083356/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143980372","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}
Ian Io Lei, Alexandra Agache, Alexander Robertson, Camilla Thorndal, Ulrik Deding, Ramesh Arasaradnam, Anastasios Koulaouzidis
{"title":"Follow-up endoscopy rates as an indicator of effectiveness in colon capsule endoscopy: a systematic review and meta-analysis.","authors":"Ian Io Lei, Alexandra Agache, Alexander Robertson, Camilla Thorndal, Ulrik Deding, Ramesh Arasaradnam, Anastasios Koulaouzidis","doi":"10.1136/bmjgast-2025-001800","DOIUrl":"https://doi.org/10.1136/bmjgast-2025-001800","url":null,"abstract":"<p><strong>Objective: </strong>Colon capsule endoscopy (CCE) has emerged as a promising alternative for investigating lower gastrointestinal symptoms. However, its adoption has been limited due to concerns about cost-effectiveness, significantly influenced by follow-up endoscopy rates (FERs). Understanding CCE's FERs is crucial for its integration into routine clinical practice. We synthesised the evidence to evaluate the overall rate of further investigation in CCE.</p><p><strong>Design: </strong>A systematic review and meta-analysis were conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.</p><p><strong>Data sources: </strong>Medline, Embase, and PubMed were searched through 15 August 2024.</p><p><strong>Eligibility criteria: </strong>Studies included reporting FERs after CCE, including subsequent endoscopic procedures and radiological imaging. There were no language restrictions or limitations in CCE referral indications, patient recruitment criteria, or pathologies investigated.</p><p><strong>Data extraction and synthesis: </strong>All studies were independently screened and extracted two times by four reviewers. A random-effects model was used for meta-analysis and meta-regression to identify key contributing factors.</p><p><strong>Results: </strong>2850 participants from 19 studies were included in the analysis. Compared with the key performance indicators for FERs in colonoscopy (0.10-0.15) and CT colonography (0.25), the pooled FER for CCE was found to be 0.42 (95% CI 0.34 to 0.50). The meta-regression analysis identified complete transit rates and adequate bowel cleansing quality as factors inversely associated with FERs. Furthermore, the CCE2 capsule demonstrated a higher reinvestigation risk than CCE1, likely due to its improved diagnostic accuracy. Although CCE indications were associated with lower FERs, subgroup analysis did not reach statistical significance with high heterogeneity.</p><p><strong>Conclusion: </strong>This study highlights significant FERs for CCE and identifies key contributing factors, emphasising the importance of appropriate patient selection to reduce reinvestigation needs. Future research should focus on improving completion rates, bowel preparation protocols, and refining CCE indications. This will minimise environmental impact and enhance cost-effectiveness and patient satisfaction.</p><p><strong>Prospero registration number: </strong>CRD42024567959.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"12 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12067854/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143978626","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}
Gregory David Salinas, Emily Belcher, Sylvie Stacy, Pradeep P Nazarey, Susan E Cazzetta
{"title":"Clinician management of patients with Crohn's-related perianal fistulas: results of a multispecialty case-based survey.","authors":"Gregory David Salinas, Emily Belcher, Sylvie Stacy, Pradeep P Nazarey, Susan E Cazzetta","doi":"10.1136/bmjgast-2024-001711","DOIUrl":"https://doi.org/10.1136/bmjgast-2024-001711","url":null,"abstract":"<p><strong>Objective: </strong>A case-based survey was conducted to identify practice patterns and knowledge gaps in the management of Crohn's perianal fistulas (CPF) and to further understand approaches to CPF management within the USA by healthcare professionals (HCPs) from different specialties.</p><p><strong>Methods: </strong>The web-based survey, comprising two hypothetical patient case vignettes (case 1: initial CPF presentation and progression to partial response; case 2: recurrent CPF), was distributed September-October 2020 to US gastroenterologists (GEs) and colorectal surgeons (CRSs), and nurse practitioners (NPs) and physician assistants (PAs) from these specialties, who managed ≥1 patient with CPF/month. The survey included questions on clinician evaluation and treatment approach.</p><p><strong>Results: </strong>Across surveyed HCPs (127 GEs, 63 GE NP/PAs, 78 CRSs and 14 CRS NP/PAs), 39% stated that they did not use any standard system for classifying/scoring CPF. On initial CPF presentation, ≥98% of HCPs reported a requirement for additional diagnostic/imaging evaluation before proceeding with medical management; GEs preferred pelvic MRI (70%) and CRSs preferred examination under anaesthesia (62%). Preferred management after partial response to initial treatment varied by HCP type (23% GEs vs 71% CRSs preferred continuation of current medical therapy; 60% vs 38% preferred seton continuation; 24% vs 41% preferred seton removal, respectively). For recurrent CPF, most HCPs chose to switch from infliximab to another antitumour necrosis factor agent, while most GEs opted to switch to a different monoclonal antibody. In contrast, 44% of GEs and 27% of CRSs opted to proceed with surgery.</p><p><strong>Conclusion: </strong>Lack of consensus in CPF management requires improved coordination in treatment approaches among specialists.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"12 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12067841/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143954406","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":"Case-mix-adjusted mean number of polyps per 100 procedures: a new candidate gold standard colonoscopy key performance indicator.","authors":"Jamie Catlow, Liya Lu, Linda Sharp, Matt Rutter","doi":"10.1136/bmjgast-2025-001743","DOIUrl":"https://doi.org/10.1136/bmjgast-2025-001743","url":null,"abstract":"<p><strong>Objective: </strong>Adenoma detection rate (ADR) has been criticised as a colonoscopy key performance indicator (KPI), for excluding serrated polyps, requiring histological data and fostering a 'one-and-done' attitude. We hypothesised that a case-mix-adjusted mean number of polyps (aMNP) would address these criticisms and provide a better measure of colonoscopy quality. We aimed to develop an aMNP using the National Endoscopy Database (NED) and assess its relationship with quality metrics.</p><p><strong>Methods: </strong>We extracted colonoscopy data from NED for 1 January 2019-4 April 2019. Multiple negative binomial regression was undertaken to estimate effects of patient variables on MNP and generate aMNP. Associations between aMNP and polyp detection rate (PDR), proximal polypectomy rate (PPR), postcolonoscopy colorectal cancer (PCCRC) rate and Joint Advisory Group for GI endoscopy (JAG) Global Rating Scale (GRS) were explored.</p><p><strong>Results: </strong>92 892 colonoscopies were analysed. Patient age, sex and procedure indication were significantly associated with MNP and used to create aMNP. At endoscopist level, aMNP strongly correlated with PDR (Spearman rho=0.834, p<0.001) and PPR (rho=0.709, p<0.001). Median aMNP was significantly lower in Trusts with higher versus lower PCCRC rates (73.9 vs 67.0 polyps per 100 procedures, p=0.047) and higher in units with GRS A/B versus C/D (aMNP 63.5 vs 55.2, p<0.001).</p><p><strong>Conclusions: </strong>We demonstrate a method to compute a novel case-mix-adjusted KPI, aMNP, which is significantly associated with PDR, PPR, PCCRC and JAG GRS. Histological data were unavailable. aMNP addresses many limitations of ADR, adjusts for warranted variation in detection, and hence may improve audit and feedback engagement. We propose it as a candidate gold standard KPI for reporting endoscopy quality.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"12 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12049872/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143972426","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}
Seán Fennessy, Caoimhe McGarvey, Edel McDermott, Richéal Burns, Patrick Redmond
{"title":"Impact of digital health interventions on patient satisfaction in outpatient gastrointestinal endoscopy: a systematic review.","authors":"Seán Fennessy, Caoimhe McGarvey, Edel McDermott, Richéal Burns, Patrick Redmond","doi":"10.1136/bmjgast-2025-001744","DOIUrl":"https://doi.org/10.1136/bmjgast-2025-001744","url":null,"abstract":"<p><strong>Objectives: </strong>The integration of digital health technologies in gastrointestinal (GI) endoscopy presents opportunities to enhance patient experience, an important dimension of care quality. This systematic review aims to evaluate the impact of digital health interventions on patient satisfaction and experience in outpatient endoscopy settings.</p><p><strong>Design: </strong>A systematic review and narrative synthesis were conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines and the Grading of Recommendations Assessment, Development and Evaluation approach.</p><p><strong>Data sources: </strong>PubMed/Medline, EMBASE, PsycInfo, and Cochrane databases were searched through 9 March 2023.</p><p><strong>Eligibility criteria: </strong>Studies were eligible if they involved adult patients (≥18 years) undergoing outpatient colonoscopy or gastroscopy and in English. Interventions included any form of educational digital health technology aimed at enhancing healthcare delivery. Telehealth studies were not included.</p><p><strong>Data extraction and synthesis: </strong>Two independent reviewers extracted data and assessed risk of bias, using the Mixed Methods Appraisal Tool. A mixed-method approach was employed for the narrative synthesis, focusing on the primary outcome of patient experience and satisfaction.</p><p><strong>Results: </strong>Nine studies met the inclusion criteria, all assessing patient satisfaction rather than experience. Five studies reported improved satisfaction associated with digital interventions, three showed no significant change, and one lacked statistical analysis. Interventions ranged from smartphone applications to online educational resources, and satisfaction measurement tools varied significantly. Overall, the evidence was characterised by heterogeneity and very low methodological quality.</p><p><strong>Conclusion: </strong>Digital health interventions may have a positive impact on patient satisfaction in GI endoscopy, although evidence quality is very low and outcome measurement is inconsistent. Future research should focus on standardising measures of patient experience and satisfaction, ensuring robust study designs to inform the integration of digital health tools into endoscopy practice.</p><p><strong>Prospero registration number: </strong>CRD42023428609.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"12 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12015691/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143963268","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}
Giacomo Emanuele Maria Rizzo, Laura Apadula, Matteo Piciucchi, Serena Stigliano, Giulio Belfiori, Nicolò de Pretis, Armando Gabbrielli, Luca Barresi, Luca Frulloni, Massimo Falconi, Silvia Carrara, Carlo Fabbri, Gabriele Capurso
{"title":"Italian Chronic Pancreatitis Registry (ITARECIPE): protocol for a nationwide cohort study.","authors":"Giacomo Emanuele Maria Rizzo, Laura Apadula, Matteo Piciucchi, Serena Stigliano, Giulio Belfiori, Nicolò de Pretis, Armando Gabbrielli, Luca Barresi, Luca Frulloni, Massimo Falconi, Silvia Carrara, Carlo Fabbri, Gabriele Capurso","doi":"10.1136/bmjgast-2025-001747","DOIUrl":"https://doi.org/10.1136/bmjgast-2025-001747","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic pancreatitis (CP) is a progressive inflammatory disease of the pancreas leading to permanent damage, resulting in both exocrine and endocrine insufficiency. Understanding the management of patients with CP and their outcomes is critical for improving patient care. CP is relatively rare in Italy and is characterised by various aetiologies and clinical progression requiring personalised treatment options. This registry (ITARECIPE) aims to prospectively collect and analyse data on patients with newly diagnosed CP to gain insights into its epidemiology, presentation, disease progression, and treatment outcomes.</p><p><strong>Methods and analysis: </strong>This is a multicentre, observational, non-interventional incident cohort study supported by the Italian Association for the Study of the Pancreas and endorsed by relevant Italian gastroenterological societies. ITARECIPE is the first registry in Italy focusing on newly diagnosed CP patients, leading to a comprehensive understanding of disease onset and progression. The study plans to enrol ≥300 patients annually over a minimum of 5 years. Data are recorded in a pseudo-anonymous electronic Case Report Form (eCRF) at baseline and follow-up visits, covering patient demographics, comorbidities, chronic medications, CP aetiology, pancreatic function (exocrine and endocrine), pain, complications, imaging, laboratory tests and treatments. It will track epidemiology, clinical history and treatment outcomes, potentially improving adherence to best practices and informing health policy decisions. The ITARECIPE registry will contribute significantly to the understanding of CP by providing detailed epidemiological, clinical and examinations data into disease management, which could help the development of future clinical practice and guidelines.</p><p><strong>Ethics and dissemination: </strong>The study was approved by the Ethics Committee (EC) of the promoter centre (San Raffaele Hospital, Milan, Italy; approval code 178/2022) and subsequently by the EC of each participating centre. All patients will be included after signing written informed consent and will be recorded in a pseudo-anonymous manner in a specific eCRF, in accordance with international principles and recommendations for observational studies. The ongoing results may be presented at national or international conferences and will be reported in peer-reviewed publications.</p><p><strong>Trial registration number: </strong>NCT05733130.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"12 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12015697/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143966302","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}
Nele Brusselaers, Habiba Khodir Kamal, David Graham, Lars Engstrand
{"title":"Proton pump inhibitors and the risk of gastric cancer: a systematic review, evidence synthesis and life course epidemiology perspective.","authors":"Nele Brusselaers, Habiba Khodir Kamal, David Graham, Lars Engstrand","doi":"10.1136/bmjgast-2024-001719","DOIUrl":"https://doi.org/10.1136/bmjgast-2024-001719","url":null,"abstract":"<p><strong>Objectives: </strong>Since proton pump inhibitors (PPI) have been introduced, many concerns were raised regarding potential gastric carcinogenicity. We aim to summarise and weigh the epidemiological evidence and address possible causality.</p><p><strong>Design: </strong>Systematic literature review, evidence synthesis and life-course assessment.</p><p><strong>Data sources: </strong>PubMed, Web of Science and Cochrane database (from inception up to October 2024), and back- and forward citation tracking (Web of Science).</p><p><strong>Eligibility criteria: </strong>Original studies and quantitative evidence syntheses assessing the association between PPIs and gastric cancer in humans, without language restrictions.</p><p><strong>Data extraction and synthesis: </strong>Study design, definitions (and participant numbers) of PPI use and gastric cancer, study characteristics (setting, period, follow-up, lag-time), age and sex distribution presented in tables and evidence mapping.</p><p><strong>Results: </strong>We identified 33 original studies, 21 meta-analyses, three umbrella meta-analyses, one individual patient data meta-analysis and a Markov model (2006-2023). PPIs were consistently associated with an increased gastric cancer risk with 20/21 meta-analyses reporting pooled relative risks between 1.3 and 2.9. Available trials were underpowered. Reverse causation/protopathic bias, residual confounding (by indication) and lag time seem the largest methodological challenges, as well as disentangling the effects of <i>Helicobacter pylori</i> and its' eradication. Insufficient data are available on age and sex-specific risks, with no studies specifically addressing PPIs in young populations. We hypothesise a sensitive-period exposure model, in which PPI use during pregnancy and early life may be particularly damaging regarding long-term cancer risk. An exploration of Swedish cancer incidence data suggests potential cohort effects as overall gastric cancer risk decreased over time (1970-2022). The risk has increased in young (<40 years) men since the early 2000s, ~10 years after the introduction of <i>Helicobacter pylori</i> eradication and PPIs.</p><p><strong>Conclusion: </strong>Although for older individuals with valid indications, the gastric cancer risk related to PPI use may be limited, we do argue for a more rational and evidence-supported use of PPIs in young populations.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"12 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12010335/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143978627","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}