BMJ Open Gastroenterology最新文献

Objective: Incomplete investigations challenge the clinical use of colon capsule endoscopy (CCE). This results in added cost to healthcare systems and added discomfort to patients. In order to potentially lower the re-investigation rate, we aimed to investigate the association between multiple patient characteristics and complete CCE.

Methods: In 2020, the CareForColon2015 (CFC2015) Trial was initiated in the Region of Southern Denmark, investigating the performance of CCE in colorectal cancer screening. Data from the CFC2015 Trial were combined with data from multiple national registers. Completion rates were calculated and their relation to the different patient characteristics was analysed in univariate and multivariate logistic regression models.

Results: We analysed 1472 participants, of whom 1016 (69.1%) had complete investigations. We investigated the associations between 17 patient characteristics and complete CCE investigation. The multivariate analysis showed that smokers and heavy drinkers had a higher probability of a complete investigation, with ORs of 1.69 (95% CI 1.12 to 2.55) and 2.72 (95% CI 1.52 to 4.87), respectively, compared with non-consumers. We also found that increasing income was associated with increased odds of CCE completion (OR 1.78, 95% CI 1.30 to 2.43, for the highest quartile). High body mass index (>40) and self-reported constipation or laxative use were significantly associated with incomplete CCE, with ORs of 0.40 (95% CI 0.17 to 0.97) and 0.65 (95% CI 0.47 to 0.90), respectively.

Conclusion: This study tested multiple factors for association with CCE completion. The results indicate that some factors are associated with higher odds of completion, while others are associated with lower odds of completion. These results confirm that specific patient characteristics correlate with the odds of complete investigation. This can, in turn, be used to determine the individual diagnostic pathway. Additional studies are needed for less frequently reported characteristics and to further support these findings.

Objective: Across several clinical specialties, research-active hospitals deliver higher-quality care and achieve better patient outcomes. To date, these associations have primarily been demonstrated using hospital-reported metrics, with limited insight from the patient perspective. This study evaluated, for the first time, the association between research activity within UK inflammatory bowel disease (IBD) hospital services and adult patient-reported quality of care.

Methods: A cross-sectional analysis was conducted using 2023 national IBD UK benchmarking Patient and Service Survey data linked with research recruitment metrics from the National Institute for Health and Care Research Central Portfolio Management System (CPMS) between 2020 and 2022. Patient-reported high-quality care in the preceding 12 months was defined as a response of 'good', 'very good' or 'excellent' on a five-point Likert scale. Research activity was measured by the number of participants recruited to CPMS-registered IBD studies managed by gastroenterology. Associations were assessed using Spearman's correlation and multivariate regression, adjusting for service-level factors.

Results: Recruitment data from 32 391 research participants across 176 IBD services were aligned with 11 454 care quality and 13 583 research opportunity patient responses. A positive correlation was observed between IBD service research recruitment volume and the proportion of patients reporting high-quality care (rₛ=0.19, p=0.013). This association remained significant after adjusting for tertiary status, service size, number of consultants and presence of an IBD leadership team (adjusted β (SE)=0.0008 (0.0004); p=0.029). Services recruiting to interventional studies demonstrated higher patient-reported care quality, while those offering research opportunities reported both higher care quality and greater research recruitment.

Conclusion: IBD service research activity is positively associated with patient-reported care quality. Embedding research engagement within routine service delivery may improve patient experience and support quality improvement. The results have important implications for service design, workforce planning and national research policy.

Objective: To assess the efficacy, safety and compliance with dual, triple and quadruple therapy first-line regimens for Helicobacter pylori eradication.

Design: A systematic review and network meta-analysis (NMA) reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses NMA guidance.

Data sources: PubMed, Cochrane Library, ProQuest and Scopus were searched until 12 October 2025.

Eligibility criteria: Randomised controlled trials (RCTs) published in English that measured the eradication rate, adverse events and compliance rates of dual therapy compared with triple or quadruple therapy for H. pylori first-line treatment.

Data extraction and synthesis: Data extraction and risk-of-bias assessment were performed by two independent reviewers. The data were analysed and represented as pooled ORs. Heterogeneity was assessed using meta-regression and trim-and-fill analyses.

Results: Pairwise meta-analysis of 56 RCTs showed that dual therapy had no different eradication rates than triple therapy (intention-to-treat (ITT): OR 0.88, 95% CI 0.60 to 1.29; per-protocol (PP): OR 0.76, 95% CI 0.46 to 1.25). Dual therapy outperformed quadruple therapy (OR 1.20, 95% CI 1.04 to 1.39) with fewer adverse events (OR 0.32, 95% CI 0.28 to 0.38) and higher compliance rates (OR: 1.49, 95% CI 1.26 to 1.76). Based on the NMA, RAC-7 has the highest probability of effective treatment for both ITT (P-score=0.9436) and PP (P-score=0.9545).

Conclusion: Dual therapy represents a promising first-line option, demonstrating comparable efficacy and adverse event rates with higher compliance, although triple therapy showed the highest probability of being the most effective first-line regimen in the NMA, followed by quadruple therapy. Further studies in non-Asian populations, along with resistance-guided treatment approaches, are needed to refine global eradication strategies.

Objective: Proton-pump inhibitors (PPIs) are among the most widely prescribed long-term medications worldwide, yet concerns remain about their potential role in colorectal carcinogenesis. Experimental data suggest that PPI-induced hypergastrinaemia may promote colonic epithelial proliferation, but epidemiological findings are inconsistent, and colonoscopy-based evidence is limited.

Methods: We studied 4476 asymptomatic adults who underwent structured screening colonoscopy in Austria between 2007 and 2020 as part of the Sakkopi study. Regular PPI use, including dose stratification, was evaluated in this retrospective analysis in relation to adenoma prevalence, burden and anatomical distribution. Multivariable logistic regression was adjusted for age, sex, metabolic syndrome, smoking status and family history of colorectal cancer. Multinomial models examined non-advanced and advanced adenomas separately.

Results: A total of 322 (7.2%) participants reported regular PPI use. Compared with non-users, PPI users were older, had higher body mass index and more frequently fulfilled metabolic syndrome criteria. Adenomas were detected in 39% of PPI users and 33% of non-users (p=0.032). In adjusted analyses, PPI use was not associated with adenoma presence (OR 1.05; 95% CI 0.83 to 1.35), number or distribution. Dose stratification showed no gradient effect: adjusted ORs were 0.85 (0.58 to 1.26) for half-dose and 1.19 (0.83 to 1.7) for standard-dose therapy. Multinomial analyses yielded consistent null results for both non-advanced and advanced adenomas in adjusted analysis.

Conclusion: In this large and well-characterised screening cohort, regular PPI therapy was not associated with colorectal adenoma prevalence, irrespective of dose or lesion characteristics.

Introduction: Biologic therapies, such as vedolizumab (VDZ) and ustekinumab (UST), offer effective treatment options for inflammatory bowel disease. In spite of limited evidence, it is common practice to escalate the dosing regimen if clinical symptoms or biomarkers give suspicion of loss of response. This study aims to determine whether model-informed precision dosing (MIPD) can provide equal efficacy and possibly superior cost-effectiveness compared with symptom-based management.

Methods and analysis: This study is an unblinded, randomised controlled trial, conducted at six centres in Denmark. A total of 166 patients diagnosed with Crohn's disease or ulcerative colitis who have been on stable VDZ or UST therapy for at least 3 months will be enrolled. Participants will be randomised to receive either continued symptom and biomarker-based dosing (control group) or dosing guided by therapeutic drug monitor using pharmacokinetic (PK) models together with PK-pharmacodynamic targets (=MIPD; intervention group). The primary endpoint is the fraction of patients in steroid-free remission at the end of the observation period. Secondary endpoints include mucosal healing, clinical remission, biochemical disease control, PK assessment and cost-effectiveness.

Ethics and dissemination: The trial has been approved by the Danish Medicines Agency and The Medical Research Ethics Committee. No study-related procedures will take place before patients have signed written informed consent. Results will be published in peer-reviewed journals and presented at international conferences.

Trial registration numbers: EUCT, 2024-517123-39-00; NCT06788340.

Introduction: Gastrointestinal (GI) endoscopy is a valuable diagnostic tool for identifying upper and lower GI pathologies yet is rarely available in resource-limited settings. This project evaluates the impact of a mobile endoscopy outreach effort implemented across five district hospitals in the Western Cape of South Africa.

Methods: A mobile endoscopy outreach programme was created and implemented at five district hospitals within the Western Cape of South Africa. Health records of patients who presented for endoscopy across these five hospitals were then retrospectively reviewed. Descriptive statistics were used as part of data analysis.

Results: A total of 515 procedures (486 oesophagogastroduodenoscopies (94%), 28 colonoscopies (5%) and one proctoscopy (0.2%)) were performed at five district hospitals between January and November of 2024 (323 female (63%), 192 male (37%); mean (SD) age 56 (14) years). The most common pathologies identified across all sites included gastritis (76%), hiatal hernia (70%) and oesophagitis (69%). For all patients, the average distance travelled to their nearest district hospital (Beaufort West, Oudtshoorn, Riversdale, Mossel Bay or Knysna) was 13.6 km (SD (26.6)), compared with the average distance they would have needed to travel to the regional referral centre (mean (SD) 102.1 (66.8) km) in George, South Africa, for the same endoscopy services.

Conclusion: Implementing a mobile, cost-conscious endoscopy outreach programme can offer diagnostic and therapeutic opportunities to patients in international resource-limited settings, while also alleviating resource strain on regional referral centres. This approach can improve healthcare access and can be replicated in other resource-limited settings.

Objectives: Approximately 50% of patients with Crohn's disease (CD) undergo surgery, and a significant proportion suffer from a post-surgical recurrence. We conducted a network meta-analysis to compare the efficacy of various interventions.

Design: Systematic review and network meta-analysis.

Data sources: MEDLINE, EMBASE and Cochrane Library were searched from inception up to February 2025.

Eligibility criteria: Randomised controlled trials (RCTs), reported in any language, comparing treatments used for maintaining surgically induced remission in CD were included. The primary outcomes were clinical relapse, endoscopic relapse and withdrawal due to adverse events.

Data extraction and synthesis: Two reviewers independently extracted data and assessed risk of bias. Certainty of evidence was rated with GRADE (Grading of Recommendations Assessment, Development and Evaluation), and SUCRA (surface under the cumulative ranking curve) was used to rank treatments.

Results: There were 34 RCTs (n=3197). For clinical relapse, adalimumab reduced the risk of relapse compared with placebo (moderate certainty), risk ratio (RR) 0.31 (95% CI 0.16 to 0.60), moderate effect size. Two treatments may reduce the risk of clinical relapse (low certainty): 5-aminosalicylic acid (RR 0.79, 95% CI 0.66 to 0.94; trivial effect size) and purine analogues (RR 0.79, 95% CI 0.66 to 0.96; trivial effect size). All other treatments were of very low certainty. For endoscopic relapse, vedolizumab probably reduced the risk of relapse (moderate certainty), RR 0.37 (95% CI 0.17 to 0.80), large effect size. Adalimumab may reduce the risk of endoscopic relapse (low certainty), RR 0.47 (95% CI 0.27 to 0.80), large effect size. All other treatments were of very low certainty.

Conclusions: Adalimumab and vedolizumab reduce endoscopic relapse with moderate to large effects supported by moderate to low certainty evidence. Adalimumab also prevents clinical relapse with moderate certainty. Other therapies either had evidence of trivial effect size or very low certainty evidence. Postoperative maintenance should be individualised based on patient risk and treatment profile.

Objective: Cholestatic pruritus is commonly reported in primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC); however, information on pruritus in other chronic liver diseases (CLDs) is limited. This survey-based cohort study characterised the severity, persistence and impact of pruritus in PBC, PSC, chronic hepatitis B or C virus infection (HBV/HCV), drug-induced liver injury, autoimmune hepatitis (AIH) and metabolic dysfunction-associated steatohepatitis (MASH). Here, we focus on groups that recruited the most participants: PSC, MASH and HCV. Results are presented in the context of PBC.

Methods: Adults with a CLD of interest from the USA, the UK, Canada and Germany were screened for the presence of pruritus via the worst-itch numerical rating scale (WI-NRS, 3-month recall) between January 2021 and January 2022. Enrolled participants (single liver disease, non-transplant recipients) self-reporting pruritus with no extrahepatic causes in the past 3 months (WI-NRS≥1) were eligible for further health-related quality-of-life (HRQoL) assessments, including WI-NRS (2-week recall), 5-dimensional itch scale and version two of the 36-Item Short-Form Health Survey. Questionnaires were administered at baseline (month 0), month 3 and month 6.

Results: Of 717 screened participants, 40.4% (AIH)-72.7% (HCV) reported any pruritus. Of 403 eligible participants, 357 were enrolled. Time since onset of pruritus to enrolment ranged from 28.0 (MASH) to 77.5 months (PBC). Baseline WI-NRS scores ranged from 3.8 (MASH) to 5.1 (PSC). The most selected terms used to describe pruritus across all CLDs were 'deep itch' and 'urgent itch' (range: 53.7% (HCV)-77.0% (PSC)). Participants with more severe pruritus had worse HRQoL. Intimate relationships, emotional well-being and ability to concentrate were negatively impacted by pruritus. Pruritus persisted over the 6-month study period across all CLDs.

Conclusion: Our study highlights the burden of pruritus experienced by participants across CLDs, highlighting a need to improve symptom recognition and treatments focused on improving HRQoL.

Introduction: Familial adenomatous polyposis (FAP) is a rare autosomal dominant syndrome that, if untreated, carries a 100% lifetime risk of developing colorectal cancer. Proctocolectomy with ileal pouch-anal anastomosis (IPAA) is a surgical approach for FAP management, but data on long-term outcomes remain limited. This study aimed to assess IPAA-associated pouch excision, dysplasia, polyp management and pouchitis in patients with FAP post IPAA.

Methods: Single-centre retrospective review of patients with FAP with IPAA at a tertiary referral centre. Data on demographics, pouch excision, endoscopic and histopathological records were collected. Statistical analysis was performed using Excel and GraphPad.

Results: Forty patients with FAP with IPAA were included. The median age was 48 years (IQR 33-58.5), with a median age of 22 years at pouch formation (IQR 18-30.5) and a median pouch age of 217 months (IQR 143-279). A total of 230 lower gastrointestinal endoscopies were assessed. Low-grade dysplasia was identified in 70 endoscopies, and polyps in 82, with the pouch being the most common site. One case of rectal adenocarcinoma was identified, with no cases of high-grade dysplasia. There were 35 episodes involving polypectomy, with cold snare being the most common method (50%). Endoscopic management had a lower complication rate than surgical management (p=0.0474). Eight (20%) patients underwent pouch excision, with poor function being as common as pouch-related complications (37.5%), with a median pouch age at excision of 167 months (IQR 115.5-286.5). Endoscopic pouchitis was significantly more common in those who underwent pouch excision (p=0.0231).

Conclusion: Patients with FAP and IPAA require surveillance due to a high incidence of dysplasia and polyp formation, although malignancy remains rare. There is a significant rate of pouch excision, for which pouchitis appears to be a risk factor. Early and aggressive endoscopic management of polyps is recommended to prevent advanced disease and minimise complications associated with surgical approaches.

Objective: Endoscopic scoring of disease activity is essential in ulcerative colitis trials but is limited by inter-reader variability and operational complexity. We evaluated a novel central reading paradigm integrating two independently developed machine learning models with human adjudication for discordant cases ('2M+1H') to determine whether it is statistically non-inferior to the traditional two-reader-plus-adjudicator model.

Methods: A total of 150 full-length endoscopic videos were retrospectively scored using both the conventional central reading approach and the 2M+1H paradigm. Each machine learning model was developed independently using distinct algorithms and datasets. When the two model-generated scores disagreed, a board-certified gastroenterologist adjudicated the final score. The primary endpoint was agreement with the reference standard, measured by quadratic weighted kappa. Secondary endpoints included agreement on binary outcomes (endoscopic improvement and remission), reduction in human reads and evaluation of outcome variability due to human reader mix.

Results: The 2M+1H approach achieved a quadratic weighted kappa of 0.78 with the reference standard, meeting the prespecified threshold for non-inferiority. Agreement with the reference standard was 82.7% for endoscopic improvement and 89.3% for remission. Compared with the traditional method, the 2M+1H paradigm reduced human reads per video by 81%. Notably, 16% of cases in the human-only approach yielded different final scores depending on reader assignment.

Conclusion: The 2M+1H central reading paradigm provides statistically non-inferior accuracy with greater operational efficiency and potentially enhanced reproducibility. Prospective validation against clinical, biomarker and histological outcomes is warranted.