BMJ Open Gastroenterology最新文献

Introduction: Cholangiocarcinoma (CCA) carries a high risk of recurrence even after curative resection. Capecitabine is standard adjuvant therapy, but recurrence rates remain significant, particularly in high-risk patients. Immunotherapy has shown promise in advanced CCA, prompting investigation into its role in earlier settings.

Methods and analysis: This multicentre, randomised, open-label phase II trial will compare adjuvant adebrelimab plus capecitabine versus capecitabine alone in patients with high-risk resected CCA. The study is being conducted at four tertiary hospitals in Jiangsu Province, China. Eligible patients will be randomised 1:1. The primary endpoint is 1-year recurrence-free survival rate (1y-RFS rate). Secondary endpoints are overall survival, RFS and safety. Exploratory endpoints are circulating tumour DNA (ctDNA)-based MRD assessment.

Ethics and dissemination: The study is approved by the Institutional Review Board of Jiangsu Provincial People's Hospital (2024-SR571). Informed consent will be obtained from all participants. The findings will be published in peer-reviewed journals and presented at scientific conferences.

Trial registration number: NCT06607276.

Objective: During the early COVID-19 pandemic, UK guidelines advocated faecal immunochemical tests (FIT) with a threshold of 10 µg/g to help secondary care clinicians triage urgent suspected colorectal cancer (CRC) referrals. We aimed to evaluate the real-world performance and impact of FIT in a high-risk cohort referred against National Institute for Health and Clinical Excellence NG12 (2015) criteria.

Methods: Multicentre prospective observational cohort study of FIT at all four secondary care hospitals in Devon (UK) between 1 April 2020 and 31 December 2020. FIT use was at the discretion of primary and secondary care clinicians. Incident CRC cases were identified ≥12 months after general practitioner (GP) referral using regional National Bowel Cancer Audit data linkage. We assessed diagnostic accuracy and healthcare utilisation in patients with and without FIT.

Results: Overall, 6698 patients were included: 55% female, median age 72 years (IQR 65-82). Just over half (53%, 3552) of patients underwent FIT with a positivity rate of 34% (n=1237). CRC prevalence in patients with no FIT, positive FIT and negative FIT was 6% (189), 11% (137) and 0.5% (11), respectively. The prevalence of all cancers, including non-CRCs, was similar among FIT and no-FIT cohorts (p=0.74). Sensitivity and specificity of FIT for CRC were 0.93 (95% CI 0.87 to 0.96) and 0.68 (95% CI 0.66 to 0.69), respectively. Patients with negative FIT underwent fewer lower gastrointestinal endoscopies (no FIT 62% (1964) vs positive FIT 69% (857) vs negative FIT 36% (835)), p=0.0005).

Conclusions: FIT is a useful triage tool for patients with suspected CRC which safely reduces endoscopy demand and prioritises those at greatest cancer risk. Standardised regional referral pathways, greater use of 'straight-to-test' investigations and GP support are needed to maximise its impact.

Colorectal cancer (CRC) remains a leading cause of cancer-related morbidity and mortality worldwide, with early detection being crucial for improving patient outcomes. While colonoscopy is the gold standard for CRC screening, stool-based tests such as guaiac-based faecal occult blood test and faecal immunochemical test offer non-invasive and cost-effective alternatives. These tests have proven value in the outpatient screening of asymptomatic, average-risk individuals; however, their frequent misuse in inpatient settings limits their diagnostic accuracy and utility. Inappropriate use of faecal occult blood tests (FOBTs) in hospitalised patients often results in false-positive or false-negative findings, leading to unnecessary diagnostic procedures, delayed treatment, increased healthcare costs and potential patient harm. Addressing this issue requires promoting adherence to guideline-based use of FOBT, alongside targeted provider education to reduce misuse, improve diagnostic precision and optimise patient care.

Objective: Proton pump inhibitors' (PPIs) widespread use raises concerns about bone health, renal outcomes, and iron deficiency anaemia (IDA). We aim to address these concerns via comprehensive matching.

Methods: Using TriNetX 1:1 propensity score matching (PSM), we compared PPI and histamine-2 receptor antagonist (H2RA) users in terms of renal outcomes (eg, estimated glomerular filtration rate and chronic kidney disease (CKD) stages), bone health (osteoporosis and fractures), and IDA (International Classification of Diseases codes and laboratory values).

Results: After 1:1 PSM, 126 155 matched patients (mean age 59 years, estimated glomerular filtration rate (eGFR) 84-86 mL/min/1.732 m²) with fewer comorbidities (24% diabetes, 18% ischaemic heart disease, 11% heart failure, 11% nicotine dependence, 4% osteoporosis) were included. After follow-up, patients in the PPI group had a significantly lower mean eGFR compared with those in the H2RA group (75.74 ± 37.56 vs 78.60 ± 35.23 mL/min/1.732 m², p<0.001). The PPI group also demonstrated significantly increased risk of CKD progression, with HR of 1.137 (95% CI 1.120 to 1.154) for stage 3a, 1.260 (95% CI 1.235 to 1.286) for stage 3b, 1.316 (95% CI 1.288 to 1.345) for stage 4, and 1.785 (95% CI 1.718 to 1.854) for stage 5. In addition, PPI users exhibited higher risks of osteoporosis (HR 1.119, 95% CI 1.071 to 1.169) and major bone fractures (HR 1.153, 95% CI 1.110 to 1.198). The risk of IDA was also significantly elevated in the PPI group (HR 1.761, 95% CI 1.691 to 1.835). Findings were consistent across all subgroups and regions.

Conclusion: In this large matched cohort, PPI use was associated with higher risks of CKD, osteoporosis, fractures, and IDA. Clinicians should monitor long-term PPI users for these potential adverse effects.

Objective: Liver diseases are established risk factors for hepatobiliary and pancreatic cancers. This study explores the relationship between liver disease and hepatobiliary-pancreatic cancers, focusing on transaminase levels and genetic susceptibility.

Methods: We conducted a large cohort study using data from 449 815 participants in the UK Biobank. Logistic regression models assessed cancer risks in liver disease versus control groups. The association between transaminase levels, polygenic risk scores (PRS), and hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), biliary tract cancer, and pancreatic cancer was examined. Two-sample Mendelian randomisation (MR) investigated the causal relationships between liver diseases and the four cancers.

Results: Liver disease and elevated transaminase levels were significantly associated with increased cancer risks (p<0.001). Higher alanine transaminase and aspartate transaminase PRS were linked to increased HCC risk (HR=1.69, 95% CI 1.38 to 2.08; HR=1.79, 95% CI 1.46 to 2.19). MR analysis revealed a causal link between alcohol-associated liver disease (ALD) and both HCC (OR=1.379, 95% CI 1.109 to 1.714) and ICC (OR=1.429, 95% CI 1.130 to 1.807), while metabolic dysfunction-associated steatotic liver disease showed no significant associations.

Conclusion: Patients with liver diseases have a significantly higher risk of hepatobiliary and pancreatic cancers, and individuals with elevated transaminase levels also exhibit a genetic predisposition to HCC. ALD demonstrates significant causal relationships with HCC and ICC.

Objective: The incidence of hypoxia in painless gastrointestinal endoscopy is not negligible. A nasal mask oxygen kit may reduce the incidence of hypoxia compared with a regular nasal cannula.

Methods: This multi-centre, randomised, open-label clinical trial took place from 1 September 2022 to 6 June 2023 in three Chinese teaching hospitals. Participants were randomly assigned 1:1 to either the intervention or the control group. Before induction of anaesthesia, a nasal cannula was used in the control group, and a nasal mask oxygen kit was used in the intervention group. The primary outcome was hypoxia (peripheral capillary oxygen saturation (SpO₂) ≥75% but <90% for <60 s). Secondary outcomes were subclinical respiratory depression (SpO₂≥90% but <95%), severe hypoxia (SpO₂<75% or SpO₂≥75% but <90% for ≥60 s) and other adverse events.

Results: Among the 1204 initially enrolled patients, 1197 completed the study, with 597 randomised to the nasal mask oxygen kit group and 600 to the control group. Compared with the control group, the nasal mask oxygen kit significantly reduced the incidence of hypoxia during gastrointestinal endoscopy under sedation (12.5% vs 7.4%; rate difference (RD) = 0.051; 95% CI 0.018 to 0.085; p=0.003), subclinical respiratory depression (13% vs 9.4%; RD = 0.036; 95% CI 0.0005 to 0.072; p=0.047) and total adverse events (27.5% vs 18.6%; RD = 0.089; 95% CI 0.042 to 0.137; p<0.001). There was no difference in the incidence of severe hypoxia (1.17% vs 0.7%; RD = 0.005; 95% CI -0.006 to 0.016; p>0.05).

Conclusions: The nasal mask oxygen kit can decrease the incidence of hypoxia in patients with American Society of Anesthesiologists class I/II undergoing gastrointestinal endoscopy under propofol and fentanyl sedation.

Trial registration number: NCT05405530.

Background: Hepatocellular carcinoma (HCC) remains a leading cause of cancer-related mortality worldwide, with early detection playing a crucial role in improving survival rates. Artificial intelligence (AI), particularly in medical image analysis, has emerged as a potential tool for HCC diagnosis and surveillance. Recent advancements in deep learning-driven medical imaging have demonstrated significant potential in enhancing early HCC detection, particularly in ultrasound (US)-based surveillance.

Method: This review provides a comprehensive analysis of the current landscape, challenges, and future directions of AI in HCC surveillance, with a specific focus on the application in US imaging. Additionally, it explores AI's transformative potential in clinical practice and its implications for improving patient outcomes.

Results: We examine various AI models developed for HCC diagnosis, highlighting their strengths and limitations, with a particular emphasis on deep learning approaches. Among these, convolutional neural networks have shown notable success in detecting and characterising different focal liver lesions on B-mode US often outperforming conventional radiological assessments. Despite these advancements, several challenges hinder AI integration into clinical practice, including data heterogeneity, a lack of standardisation, concerns regarding model interpretability, regulatory constraints, and barriers to real-world clinical adoption. Addressing these issues necessitates the development of large, diverse, and high-quality data sets to enhance the robustness and generalisability of AI models.

Conclusions: Emerging trends in AI for HCC surveillance, such as multimodal integration, explainable AI, and real-time diagnostics, offer promising advancements. These innovations have the potential to significantly improve the accuracy, efficiency, and clinical applicability of AI-driven HCC surveillance, ultimately contributing to enhanced patient outcomes.

Objective: Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common liver disease worldwide. Weight loss, achieved by changes to lifestyle behaviours, is the recommended management approach. However, patients find this challenging. A MASLD-specific digital behavioural intervention (interVention to promote lIfesTyle change in metabolic dysfunction-Associated steatotic LIver diseaSE, VITALISE) to target changes in dietary and physical activity behaviours was developed to support weight loss. This study assessed the feasibility and acceptability of delivering VITALISE in routine secondary care.

Methods: A single-centre, one-arm feasibility study recruited participants from November 2022 to May 2023. VITALISE included MASLD-specific education, provision of self-regulation tools (ie, goal setting, food monitoring, step tracking, weight monitoring) and monthly health coaching appointments by telephone. Patients had access to VITALISE for 6 months. Primary outcomes were feasibility (recruitment, uptake, engagement, adherence, and follow-up rates) and acceptability (patient views). Secondary outcomes were body weight, liver enzymes, liver stiffness, blood pressure, lipid profile, glycated hemoglobin (HbA1c), physical activity and patient activation.

Results: 35 patients (mean age 54 years; 69% male) with MASLD were recruited to VITALISE (recruitment rate 59%). Of the 35 enrolled, 83% activated their VITALISE account. Patient interviews supported acceptability. At 6 months, mean weight loss was 4.0 kg (3.5%) and alanine transaminase reduced by 27%. A decrease in daily sedentary time and an increase in light physical activity were observed. Self-reported leisure-time physical activity and patient activation increased from baseline to 6-month follow-up.

Conclusions: VITALISE was feasible and acceptable to deliver in routine secondary care. Weight loss and improvements in lifestyle behaviours and liver enzymes were observed. Findings will inform intervention optimisation and future large-scale evaluation.

Trial registration number: ISRCTN12893503.

Objectives: Colorectal cancer screening with flexible sigmoidoscopy focuses on the distal colorectum, but it is unclear which distal polyp characteristics are associated with future proximal colon cancer incidence. We examined associations between distal adenoma or hyperplastic polyp characteristics and long-term incident proximal colon cancer.

Methods: In secondary, observational analyses of UK Flexible Sigmoidoscopy Screening Trial data, we obtained data on the number and size of distal hyperplastic polyps (n=4872) and adenomas (n=4581), adenoma histology and dysplasia from endoscopy and pathology reports for screened asymptomatic participants. Adjusted HRs and 95% CIs for the association between distal polyp characteristics and proximal colon cancer incidence were estimated using multivariable Cox proportional hazard models.

Results: Over a median of 20.7 years of follow-up (IQR 16.5-21.7), 110 proximal colon cancers were diagnosed among participants with distal adenomas and 96 were diagnosed among those with only distal hyperplastic polyps detected at baseline. Larger adenoma size (6-9 mm vs ≤5 mm: HR 1.67 (95%CI: 1.07 to 2.59) and ≥10 mm vs ≤5 mm: HR 2.08 (95%CI: 0.98 to 4.43); p=0.037) and high-grade (vs low-grade) adenoma dysplasia (HR 2.82, 95% CI: 1.34 to 5.93; p=0.012) at baseline were positively associated with proximal colon cancer incidence. No associations were observed for distal adenoma number overall or histology, or the number or size of hyperplastic polyps and proximal colon cancer incidence.

Conclusions: We found some evidence that larger distal adenomas and those with high-grade dysplasia at baseline were positively associated with proximal colon cancer incidence. Larger studies are needed to confirm these findings.

Trial registration number: ISRCTN28352761.

Objective: The advent of biological drugs has revolutionised management of inflammatory bowel disease (IBD). However, the extent to which these novel pharmacological drugs have reduced the need for surgical treatment remains incompletely quantified.We aimed to investigate the risk of first, major surgery in IBD in a population-based, large epidemiological study.

Methods: We empanelled a cohort comprising all 85 974 patients diagnosed with ulcerative colitis (UC) and 42 760 with Crohn's disease (CD) in Norway and Sweden in 1987 through 2017. We used log-rank tests to compare the cumulative probability of surgical treatment for UC and CD. Using multivariable Cox proportional hazards models, we estimated hazard ratios (HR) with 95% CIs by year of diagnosis, age, sex and extent of disease.

Results: During a mean follow-up of 9.9 years, surgery was undertaken in 11 187 (13.0%) patients with UC (12.3 per 1000 person-years) and in 11 307 (26.4%) patients with CD (30.0 per 1000 person-years). In UC, the cumulative 5-year probability of surgery decreased from 16.2% in patients diagnosed in 1987-1994 to 5.8% in those diagnosed in 2011-2017 (p<0.001). In CD, the corresponding decline was from 30.1% to 13.9% (p<0.001). In multivariable analyses, the likelihood of surgical treatment decreased during the study period by 61% (HR 0.39, 95% CI 0.36 to 0.42) in UC and by 31% (HR 0.69, 95% CI 0.65 to 0.75) in CD.

Conclusions: Following the introduction of biologic drugs, the need for surgical treatments has been dramatically reduced in patients with UC and moderately reduced in patients with CD.