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To describe work participation (WP) and receiving disability benefit (DB) in persons with chronic gastrointestinal disorders (CGID); to describe associations between the six dimensions of positive health (PH) and WP and DB, respectively; and to assess whether the type of CGID is associated with WP and receiving DB.
Cross-sectional and observational questionnaire study.
Maastricht University Medical Centre+ (tertiary care hospital), including regional, supra-regional and national referrals.
441 patients of working age (18–66 years) with CGID who visited the outpatient department of the Gastroenterology-Hepatology Clinic between March 2019 and June 2021 (mean±SD age: 45.0±14.7 years, 68.5% women).
Associations of PH dimensions and WP and receiving DB, respectively; association of type of CGID and WP, and receiving DB. The main independent variables (PH dimensions) were bodily functions, mental well-being, meaningfulness, quality of life (QoL), participation and daily functioning.
Among 441 working-age patients, 49% worked; 20% received DB (40% of non-workers). All PH dimensions related significantly to WP and DB (bivariate level). After adjusting for demographics and CGID type, better general health (dimension QoL) (OR 1.018; 95% CI 1.001 to 1.035, p=0.040) and daily functioning dimension (OR 1.030; 95% CI 1.013 to 1.047, p
Of the 441 working-age patients with CGID, only 49% worked; most non-workers did not receive DB. Of the PH dimensions, daily functioning appears most directly related to WP and receiving DB; CGID type had minimal impact.
Primary biliary cholangitis (PBC) is a rare chronic cholestatic disease that despite current therapy has significant ongoing unmet needs, including risks of cirrhosis and life-impairing symptoms. The current treatment approach is a step-up model, wherein first-line therapy, ursodeoxycholic acid (UDCA), is given for a minimum of 12 months before the addition of second-line therapy is considered for non-responding patients. This ‘waiting to fail’ approach, focused on the needs of low-risk patients, allows, we postulate, a key process of biliary epithelial cell (BEC) senescence to become established, driving accelerated bile duct loss and aggressive disease. Preclinical mouse modelling has shown that early use of the farnesoid X receptor agonist obeticholic acid (OCA), currently only used as second-line therapy following UDCA failure, reverses BEC senescence, changing the clinical course of disease. Here, we describe the design of the Optimising Primary thErapy in pRimAry biliary cholangitis (OPERA) trial. The aim of OPERA is to explore a new paradigm for disease-modifying treatment of PBC: risk-informed early treatment stratification, with patients at increased risk offered UDCA and OCA combination with the goal of complete biochemical remission.
OPERA is a multicentre, randomised, double-blind, placebo-controlled trial of OCA in combination with UDCA, as first-line treatment for high-risk PBC. This is a multicentre trial in England, which will be undertaken in specialist clinics in secondary/tertiary referral centres (or as per local set up). These centres will be specialists in the area of PBC management and will manage patients from across their local region. OPERA will recruit and randomise 106 adults, within 6 months of PBC diagnosis, who are at an enhanced risk of non-response to standard first-line therapy, between either: (1) UDCA and OCA or (2) UDCA and matched placebo in a 1:1 ratio. The primary efficacy outcome measure is the percentage of participants showing normalisation of serum alkaline phosphatase and total bilirubin values at 26 weeks (disease remission).
Favourable ethical opinion was received from London – Riverside Research Ethics Committee (reference: 22/LO/0878). Potential participants will be fully informed of their rights and the benefits and harms of the trial by the research team before giving informed consent to participate in the trial. Results will be disseminated in peer-reviewed publications, at national and international conferences, in peer-reviewed journals and to participants and the public (using lay language).
Intrahepatic cholangiocarcinoma (ICC) has a high recurrence rate after curative surgery, with no standard neoadjuvant therapy. Hepatic arterial infusion chemotherapy (HAIC) has shown efficacy in locally advanced ICC, while immune checkpoint inhibitors and anti-angiogenic agents have demonstrated promising response rates. The NEO-ERA-01 study evaluates the feasibility of neoadjuvant HAIC-GEMOX plus lenvatinib and Adebrelimab in high-risk resectable ICC.
NEO-ERA-01 is a prospective, multicentre, phase II trial using Simon’s two-stage design. Thirty patients with histologically confirmed resectable ICC and high-risk recurrence factors will be enrolled in China. Neoadjuvant therapy consists of HAIC-GEMOX (gemcitabine 800 mg/m², oxaliplatin 85 mg/m² every 3 weeks), lenvatinib (8 mg/day from Day 5) and Adebrelimab (1200 mg on Day 3, every 3 weeks) for 2–4 cycles. Surgery eligibility will be assessed post-treatment. Resected patients will receive adjuvant capecitabine (1250 mg/m² two times per day on Days 1–14, every 3 weeks) and Adebrelimab (1200 mg on Day 1, every 3 weeks) for 6 months.
The primary endpoint is the completion rate of study treatment. Secondary endpoints include safety, R0 resection rate, response rate, event-free survival, disease-free survival and overall survival. Exploratory endpoints include immune microenvironment and biomarker analysis.
The study is approved by the ethics committee of all sites and follows the Declaration of Helsinki and good clinical practice guidelines. Results will be disseminated via peer-reviewed publications and conferences.
Colorectal cancer (CRC) is the fourth most common cancer in the UK and second leading cause of cancer-related deaths. The faecal immunochemical test (FIT) is a non-invasive home-based test used for both symptomatic assessment and population-based screening. However, approximately 30% of screening FIT kits and 10% of symptomatic FIT kits are never returned. Under-served populations, including ethnic minorities, socioeconomically deprived communities and those with mental health conditions, experience particularly low FIT return rates, contributing to health inequalities in CRC outcomes. This systematic review aims to synthesise evidence on the effectiveness and acceptability of interventions to improve FIT returns in both asymptomatic screening and symptomatic populations, with particular focus on under-served communities.
We will conduct a systematic review of qualitative and quantitative evidence. We will search Scopus, MedLine via Ovid, CINAHL via Ebsco and Cochrane Central Register of Controlled Trials from September 2010 onwards, supplemented by reference screening and trial registry searches. Eligible studies will include randomised controlled trials, quasi-experimental studies, observational studies, qualitative studies, mixed-methods studies and implementation studies examining FIT interventions in screening or symptomatic populations. Two reviewers will independently screen search results for eligible studies. Data extraction will capture study characteristics, population demographics, intervention components and outcomes including FIT return rates, acceptability, feasibility and implementation factors. Quantitative data will undergo systematic tabulation and meta-analysis where appropriate, with narrative synthesis for heterogeneous studies. Qualitative data will be analysed using framework-based thematic analysis, mapping findings to both the theoretical domains framework and theoretical framework of acceptability. A mixed-methods synthesis will integrate quantitative and qualitative findings to identify intervention characteristics, implementation strategies and contextual factors associated with improved outcomes across different population groups.
Ethics approval is not required as this systematic review will analyse published studies. Findings will be disseminated through peer-reviewed publication and conference presentations.
CRD420251111663.
Gastrointestinal bleeding (GIB) is a common cause of hospitalisation and decompensation in the hospital, is routinely managed by a wide variety of subspecialties, and requires a host of both technical and non-technical skills (NTS). Simulation-based training (SBT) exercises are an excellent means of training physicians and other healthcare professionals in both technical skills and NTS and are frequently used to teach and assess management of high-stress situations such as cardiopulmonary resuscitation and trauma situations. The manner in which SBT is used to train other types of clinical situations—and at what frequency—is less clear. The extent to which such training programmes are evaluated is also not clear. Here, we intend to characterise the body of literature describing SBT programmes for bedside management of GIB. In doing so, we will gain valuable insight into the current state of SBT as it relates to training healthcare professionals to handle complicated clinical situations.
Our review will follow the six-stage framework outlined by Arksey and O’Malley while considering elaborations and guidance made by Levac et al and the Joanna Briggs Institute. The protocol and review will be created in alignment with the preferred reporting items for systematic reviews and meta-analyses—scoping review checklist and explanatory paper. Using a carefully constructed search strategy, the following databases will be queried from their inception through 31 December 2025: PubMed, Embase, Scopus, Web of Science and ERIC. Following the initial database query and two-step screening process, included articles will be systematically examined and will serve as our data source. Our efforts will ultimately answer the following research question: How is simulation-based training currently used to teach bedside management of GIB to physicians (residents, fellows and attending physicians), and how are these simulation-based training exercises studied and evaluated?
Ethical approval from the Institutional Review Board is not required for this study since all investigations are being carried out on previously published manuscripts. Final results will be compiled and submitted for publication once the study has been completed and all data has been charted/analysed.
Inflammatory bowel disease (IBD) is associated with worse major adverse liver outcomes (MALO) in patients with chronic liver disease (CLD). Although the interplay between these conditions is recognised, the contribution of external factors such as race and socioeconomic status (SES) remains unclear. We aimed to assess the association of race and socioeconomic factors with MALO in patients with IBD and CLD.
This retrospective cohort study analysed hospitalised adults with IBD and CLD using the National Inpatient Sample database (2015–2021). Demographic variables included age, sex and race. SES included household income. Clinical variables included length of hospital stay, in-hospital mortality and comorbidities. A multivariate logistic regression analysis was performed to assess the independent associations between MALO and patient demographics, comorbidities and social determinants of health.
Among 97 628 hospitalised adult patients with IBD, 4.11% (4011/97 628) had secondary CLD. The majority of patients with IBD-CLD were white (74.94% or 2928/3907), and over half (53.83% or 2118/3934) resided in lower-income households with incomes below US$35 000. Racial disparities were evident, with significant differences in comorbidities such as sepsis, cholangitis and hepatocellular carcinoma. Among white patients, the prevalence of depression and anxiety was 20.18% (591/2928) and 24.21% (709/2928), respectively, which was higher compared with other racial groups. In adjusted analyses, African American race (OR 1.42, p=0.003) and lowest SES (OR 1.19, p=0.04) were independently associated with increased odds of MALO.
African American race and lower SES are independently associated with higher odds of MALO in patients with IBD-CLD. These findings highlight disparities that warrant further investigation and suggest that targeted interventions may help improve liver-related outcomes. Interventions reducing health inequities are desperately needed to mitigate disparities in this patient population.
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder worldwide. Although not life-threatening, its chronic and recurrent nature greatly impacts patients’ quality of life. There is strong evidence that gut-directed psychotherapies (GDPs) help improve IBS symptoms. With technological advances, digital GDP is increasingly used as an alternative to traditional face-to-face GDP. This study will compare the clinical effectiveness of digital versus face-to-face GDP for IBS through network meta-analysis.
We will search English databases (PubMed, Cochrane Library, EMBASE and Web of Science) and Chinese databases (China National Knowledge Infrastructure, Wanfang, VIP and Chinese Biomedical Database) for randomised controlled trials (RCTs) of digital or face-to-face GDP for IBS. The search will cover the period from database inception to May 2025. We will perform multivariate network meta-analyses within a frequentist framework, using the mvmeta command in STATA V.16 software, and traditional pairwise meta-analysis using the DerSimonian-Laird random-effects model. The Cochrane Risk of Bias (RoB) tool (V.2) will be used to assess the RoB of each RCT, and the Confidence in Network Meta-Analysis (CINeMA) tool will be used to evaluate the certainty of the evidence.
Ethical approval is not required for this systematic review, as it involves the collection and synthesis of data from previously published primary studies.
Open Science Framework (OSF) registration: DOI 10.17605/OSF.IO/87463.
Irritable bowel syndrome with diarrhoea (IBS-D) significantly impairs patients’ quality of life. Although various non-pharmacological interventions show promise, evidence on their comparative effectiveness remains limited. This protocol outlines a systematic review and network meta-analysis designed to comprehensively evaluate and rank the efficacy and safety of guideline-recommended non-pharmacological therapies.
We will systematically search PubMed, Cochrane Library, Web of Science, Embase, China National Knowledge Infrastructure, Chinese Biomedical Database, Wanfang Data and VIP Database from inception to January 2025. Eligible studies will include randomised controlled trials assessing guideline-recommended non-pharmacological interventions, probiotics, acupuncture, cognitive–behavioural therapy, dietary modifications and faecal microbiota transplantation in adults diagnosed with IBS-D based on Rome III or IV criteria. The primary outcome is the Irritable Bowel Syndrome Symptom Severity Score. Secondary outcomes include the Irritable Bowel Syndrome Quality of Life Scale and Hospital Anxiety and Depression Scale. Two independent reviewers will screen studies, extract data and evaluate risk of bias using the Cochrane Risk of Bias 2.0 tool. Network meta-analysis will be performed using frequentist methods with Stata and R software. Transitivity, heterogeneity, consistency and publication bias will be assessed. Certainty of evidence will be graded using the Grading of Recommendations, Assessment, Development and Evaluations methodology, supplemented with trial sequential analysis to determine the required information size.
Ethical approval is not required for this secondary analysis as it uses published data. The results will be disseminated via peer-reviewed journals and conference presentations to inform clinical practice and guideline development.
INPLASY202470112.
Primary sclerosing cholangitis (PSC) is the classical hepatobiliary manifestation of inflammatory bowel disease (IBD). No therapy currently halts disease progression. The strong gut–liver axis implicated in PSC pathogenesis supports the investigation of microbiome-targeted treatments. Oral vancomycin (OV), an antibiotic with potential immunomodulatory properties, has shown encouraging results in improving clinical symptoms and liver biochemistry in PSC. However, prospective data on its safety and efficacy remain limited.
Oral Vancomycin for primary sclerosing Cholangitis in ITaly (VanC-IT) is a phase II, dose-finding, randomised, placebo-controlled, trial designed to evaluate the efficacy and safety of OV in patients with PSC, with or without underlying IBD. Adults and adolescents aged 15–75 years will be enrolled following a 10-week screening and run-in period and randomised in a 1:1:1 ratio to receive either placebo, OV 750 mg/day or OV 1500 mg/day for 24 weeks. Randomisation will be stratified by baseline liver stiffness (
The protocol has been approved by the Ethics Committee CE Brianza on 10 February 2023, number 4017. Trial registration number NCT05876182. Participants will be required to provide written informed consent. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.
To summarise the symptom clusters (SCs), assessment tools and their evolution at different stages of postsurgical chemotherapy in oesophageal cancer patients, providing reference for future research design and precise symptom management.
A systematic search and literature review were conducted according to the Joanna Briggs Institute Scoping Review Methodology framework and PRISMA extension for scoping reviews (PRISMA-ScR) guidelines.
Databases searched include PubMed, Cumulative Index to Nursing and Allied Health Literature (CINHAL), Web of Science, Embase, the Cochrane Library, Scopus, China National Knowledge Infrastructure, Wanfang, VIP Chinese Journal and China Biomedical Literature Database. The search covered the period from database inception to 30 November 2024, and references were traced backward.
Patients aged ≥18 years with postsurgical oesophageal cancer undergoing adjuvant chemotherapy; studies focusing on SCs before, during or after chemotherapy; original quantitative research; published in Chinese or English. Exclusion criteria included neoadjuvant or palliative chemotherapy, reviews, conference abstracts and inaccessible full-text articles.
Two independent reviewers screened, extracted and cross-checked the data. Content analysis was employed to summarise the SCs, assessment tools and phase-related changes.
A total of 11 studies were included (8 in Chinese, 3 in English). Twelve SCs were identified, with gastrointestinal-related, eating-related and physical function-related clusters being the most common. Eleven assessment tools were used, with MD Anderson Symptom Inventory-Gastrointestinal Cancer Module and its Chinese version being the most frequently applied. Difficulty eating was the most prominent SC before chemotherapy, gastrointestinal symptoms were the most severe during chemotherapy and psychological-physical symptoms dominated in the postchemotherapy phase.
The composition of SCs in oesophageal cancer chemotherapy evolves dynamically across different stages. However, the existing evidence is mainly derived from small sample cross-sectional studies, with high heterogeneity in tools and methods. Standardised assessment criteria and longitudinal validation are needed to develop stage-specific, evidence-based interventions that can be widely applied.
Accurate identification of adverse events after colonoscopy is essential for quality assurance in colorectal cancer (CRC) screening. Review of medical records is labour intensive as adverse events are infrequent. The object of this study was to investigate the accuracy of claims data in identifying adverse events after colonoscopy in CRC screening.
Cross-sectional, retrospective.
Males and females aged 50–74 years were randomised to once-only sigmoidoscopy or biennial faecal immunochemical test in a CRC screening trial at two screening centres in Norway. Participants in the present study underwent follow-up colonoscopy from 2012 to April 2020 after initial positive screening test. We reviewed medical records for adverse events within 30 days following 11 205 colonoscopies.
The primary outcome of the study was to assess the sensitivity of claims data from the Norwegian Patient Registry to identify lower gastrointestinal bleeding using emergency contact International Statistical Classification of Diseases and Related Health Problems 10th Revision diagnostic code sets under two definitions: a stringent definition (codes explicitly identifying bleeding) and a broad definition (including suggestive codes). Secondary outcome measures included the sensitivity to identify perforation using a stringent and a broad definition. Additionally, we assessed whether incorporating procedure codes and non-emergency contacts improved accuracy.
87 cases of lower gastrointestinal bleeding and eight perforations were confirmed. Sensitivity for bleeding differed between the centres (p
Use of claims data underestimated adverse event rates following colonoscopy. Difference in coding practice across hospitals underscores the need for standardised reporting in screening programmes.
Each year, millions of people experience recurrent diverticulitis episodes. Elective sigmoid colon resection reduces the risk of recurrence, but The American Society of Colon and Rectal Surgeons recommends individualising surgical decisions based on the impact of the condition on a patient’s quality of life (QoL). However, no threshold for QoL impairment has been established to guide decision-making, and evidence comparing elective colectomy with medical management in terms of QoL limitation is limited. To address these gaps and to guide treatment decision-making, we designed the Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) trial.
The COSMID trial is a large, pragmatic randomised trial including patients with QoL-limiting diverticulitis that aims to determine if partial colectomy is superior to medical management and explore subgroups that are more likely to respond to each treatment.
COSMID will recruit 250 English-speaking and Spanish-speaking adults with imaging-confirmed and QoL-limiting diverticulitis (defined using a modified diverticulitis-related QoL survey). Participants are randomly assigned to undergo elective partial colectomy or receive comprehensive medical management (eg, selected from options including fibre, probiotics, mesalamine and rifaximin). A total of 100 patients who decline randomisation but consent to follow-up will be included in a parallel observational cohort. The primary outcome is the time-averaged score of the Gastrointestinal Quality of Life Index at 6, 9 and 12 months after randomisation. Secondary outcomes include clinical adverse events, healthcare utilisation, recurrent episodes of diverticulitis and additional patient-reported outcomes like the Diverticulitis Quality of Life instrument, decisional regret and work productivity. Exploratory analyses aim to identify differential treatment effects based on patients’ characteristics.
This trial was approved by the Vanderbilt Institutional Review Board (IRB) on 26 August 2019 (IRB #191217). Vanderbilt serves as the institutional review board of record for the following study sites: Albany Medical College, Allegheny Health, Atrium Health Carolinas Medical Center, Virginia Mason Medical Center, Boston University Medical Center, Cedars-Sinai Medical Center, UT Health Lyndon B. Johnson Hospital, Medical University of South Carolina, New York-Presbyterian Queens, Stanford University, University of Pennsylvania, University of California San Diego, University of California San Francisco, University of Colorado Denver, University of Florida, University of Iowa, University of Utah, University of Washington Medical Center, University of South Florida, University of Rochester Medical Center, University of Texas Southwestern Medical Center, Virginia Commonwealth University, Lahey Hospital & Medical Center, Weill Cornell Medical Center and Northwell Health. Rush University Medical Center (approved 8 January 2020), Columbia University Medical Center (approved 28 January 2020), Northwestern University (approved 19 March 2020), Mount Carmel Health System (approved 5 May 2020) and Memorial Health University Medical Center (approved 4 April 2022) are regulated and were approved by their respective IRBs. Results from this trial will be presented at international conferences and published in peer-reviewed journals.
Inflammatory bowel disease (IBD) patients in China exhibit critically low levels of physical activity, yet evidence for telemedicine-based aerobic exercise interventions remains scarce, particularly with objective physiological validation.
In this single-centre, open-labelled, semi-crossover randomised controlled trial, 28 inactive/mildly active adult IBD patients with low level of baseline physical activity will be randomly assigned to immediate or delayed 12-week telemedicine-based aerobic exercise training. The exercise prescription, stratified by baseline activity level, is designed to progressively elevate physical activity levels to moderate intensity. The telemedicine-based programme used fitness bands synchronised to a mobile app, WeChat-based real-time feedback and online group support and communication. The primary outcome is change in peak oxygen uptake measured by cardiopulmonary exercise testing (CPET). Secondary outcomes include other cardiorespiratory fitness parameters measured by CPET, physical activity level measured by International Physical Activity Questionnaire Short Form, Exercise Benefits/Barriers Scale, clinical disease activity, inflammatory markers, Inflammatory Bowel Disease Questionnaire, nutritional indices, Fatigue Severity Scale and Hospital Anxiety and Depression Score.
The trial has been approved by the Ethics Committee of the Affiliated Lihuili Hospital of Ningbo University (KY2024SL379-01). Results will be published in peer-reviewed journals and presented at scientific conferences.
Three-dimensional high-resolution anorectal manometry (3D HRAM) is a minimally invasive test allowing the assessment of lower gastrointestinal tract function. Nowadays, it is performed in left lateral or supine position (non-physiological) in accordance with the London Protocol. 3D HRAM can disclose pathological defecation model such as dyssynergic defecation (DD) that might be a cause of constipation in a significant percentage of patients.
3D HRAM in healthy adults in lying position shows up to 67%–87% abnormal results during the bear-down manoeuvre; it may result from the non-physiological position taken during the examination.
The aim of this study is to assess the influence of body position on parameters of the bear-down manoeuvre during 3D HRAM in children with constipation and healthy volunteers.
This is a prospective, case-control study. Study participants of 5–18 years old will be recruited and divided into two groups: (I) patients with functional constipation and non-retentive faecal incontinence diagnosed according to the Rome IV criteria and (II) healthy controls. Tests will be performed both in supine and sitting positions, successively using 3D HRAM. The order in which the examination will be performed will be in accordance with the randomisation list generated by computer.
The primary endpoint of the study is the difference in the number of patients with DD detected in the sitting and supine positions.
The study was approved by the Ethics Committee of the Medical University of Warsaw, Poland (KB/178/2019). The results of this study will be submitted to a peer-reviewed journal no later than 1 year after data collection. The abstract will be presented at relevant national and international conferences.
Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). While etrasimod demonstrated efficacy in randomised controlled trials, understanding its effectiveness in an observational setting is crucial.
EFFECT-UC is a prospective, multinational, non-interventional study to evaluate the real-world effectiveness of etrasimod in adults with moderately to severely active UC. The study consists of a 52-week treatment period and a 28-day safety follow-up period and aims to enrol ~300 patients per cohort. Eligible patients (18–64 years) are advanced therapy naïve or experienced and are initiating etrasimod in a real-world clinical setting. Treatment will be guided independently by the clinician’s judgement. Patient-reported outcomes will be collected electronically throughout the study and daily for the first 2 weeks. Exploratory data, including faecal calprotectin, endoscopy and intestinal ultrasound, will be collected at predefined visits or during standard care. Primary endpoints are symptomatic remission at week 12 and week 52. Secondary endpoints include patient-reported outcome 2 (combined rectal bleeding and stool frequency subscores) response at week 12 and week 52 and corticosteroid-free symptomatic remission at week 52.
Ethics approval was obtained for all sites. Recruitment is underway for cohort 1, comprising patients from the UK, Germany and Canada. Interim results for this cohort are expected in 2026 and final results in 2028; these will be submitted for publication in peer-reviewed journals and presented at appropriate congresses.
Gastric cancer (GC) remains a leading cause of cancer-related mortality worldwide, with most Chinese patients diagnosed at a locally advanced stage. Neoadjuvant chemotherapy (NAC) is increasingly used to improve resectability and survival. Laparoscopy-assisted distal gastrectomy (LADG) provides short-term recovery benefits compared with open distal gastrectomy (ODG), but its safety and oncologic efficacy following NAC remain uncertain. This trial aims to determine whether LADG is non-inferior to ODG in terms of long-term survival outcomes in patients with locally advanced distal gastric cancer (LAGC) after NAC.
This is a multicentre, randomised, controlled, non-inferiority trial conducted at high-volume GC centres in China. Eligible patients (aged 18–75 years; cT3–4a, N0/+, M0) with histologically confirmed distal gastric adenocarcinoma who have completed standard NAC will be randomised 1:1 to LADG or ODG with D2 lymphadenectomy. Surgical quality will be standardised through operative manuals, intraoperative video recording and central auditing. The primary endpoint is 3-year disease-free survival. Secondary endpoints are 3- and 5-year overall survival. A total of 998 patients (499 per arm) will be enrolled, providing 80% power to test non-inferiority with an absolute 8% margin, accounting for 15% attrition. Analyses will follow the intention-to-treat principle, with Cox models used for survival comparisons and subgroup analyses according to nodal status, tumour size and pathological response.
This trial has been reviewed and approved by the Biomedical Ethics Committee of West China Hospital, Sichuan University (Approval No. 2025 (865), 16 July 2025). Written informed consent will be obtained from all participants. The results will be disseminated through peer-reviewed journals and international conferences, providing high-level evidence to guide the surgical management of LAGC after NAC.
Chinese Clinical Trial Registry, ChiCTR2500109677; registered on 23 September 2025. Protocol V.2.1, dated 29 June 2025.
Inflammatory bowel diseases (IBDs) are chronic conditions characterised by intestinal and systemic inflammation, often associated with significant psychological distress. Emerging evidence highlights a bidirectional relationship between inflammation and psychological factors, mediated by the gut-brain axis. Psychological distress may not only result from chronic inflammation but also contribute to symptom persistence and disease exacerbation. Despite this, clinical management of IBD primarily focuses on controlling inflammation, often overlooking psychological factors that may influence disease activity and treatment response.
GastroPsy protocol will last for 24 months and will follow a cross-sectional design. At least 150 participants will undergo a clinical evaluation based on the detection of biological, medical and psychological indicators and variables. The evaluation battery will comprise seven validated questionnaires. Through a k-means cluster analysis, the study aims to derive and describe data-driven clusters of IBD patients, finally exploring associations between identified clusters and external clinical variables (e.g. clinical activity).
Ethical Committee Approval was obtained from the CEtRA Abruzzo Region (IT) (Protocol ID 228/2025). The results of the present project will be published in peer-reviewed journals, disseminated electronically and in print, and presented as abstracts and/or personal communications during national and international conferences.
The potential link between proton pump inhibitors (PPIs) and hypertension remains unclear. It is uncertain whether such an association exists, whether it represents a class-of-PPI effect and whether a dose–response relationship is involved. This study aimed to investigate the potential class-of-PPI effect associating PPIs with hypertension reporting and evaluate whether the association follows a dose-dependent pattern.
A disproportionality analysis was conducted within VigiBase to identify signals of hypertension reporting associated with individual PPIs by calculating adjusted reporting ORs (aRORs) within a multivariate case/non-case study design. Additionally, the presence of a dose–response relationship was explored.
Real-world data from VigiBase, the WHO pharmacovigilance database, was used.
All individual case safety reports with PPI use were included.
Incident hypertension cases were identified using the Medical Dictionary for Regulatory Activities V.26.1 related to at least one PPI administration that were systematically collected until 28 October 2024. Pharmacovigilance signals between the use of PPIs and hypertension reported and dose dependence between PPI posology and onset or worsening hypertension were analysed.
The database contained 26 587 reports of PPI-associated hypertension (2.3%), predominantly among women (63.3%). Hypertension was most frequently reported in the group aged 45–64 years (41.4%). A significant reporting OR (ROR) was observed for almost all PPIs in both univariable (RORs, 1.32–1.97) and multivariate analyses (aRORs, 1.09–1.35) after adjustments for age group, sex, concurrent antihypertensive medication and drugs known to induce hypertension, with the exception of lansoprazole (aROR 0.99, 95% CI 0.96 to 1.03). A potential trend suggestive of a dose–response relationship was identified, with doses lower than the median associated with a lower aROR for hypertension than doses higher than the median for all PPIs. However, this trend was not statistically significant, potentially due to insufficient statistical power.
This investigation indicates a notable pharmacovigilance safety signal associating PPI usage with hypertension reporting. Although a potential dose–response trend was observed, it was not statistically significant, possibly due to limited statistical power. Further longitudinal studies are warranted.
Crohn’s disease (CD) and ulcerative colitis (UC) are chronic, inflammatory bowel diseases (IBDs) of unknown origin, affecting the gastrointestinal tract and often causing extraintestinal symptoms. Conventional treatments (eg, glucocorticosteroids, immunomodulators) and targeted advanced treatments, including anti-TNFα, antibodies to p40 subunit of IL-12/23, antibodies to p19 subunit of IL-23, anti-α4β7 integrin, Janus kinase inhibitors (JAKis) and sphingosine-1-phosphate receptor (S1PR) modulators, do not achieve sustained responses for all patients, leaving significant unmet therapeutic needs.
This prospective, multi-centre observational study will follow a cohort of 240 patients across multiple study centres within NHS trusts in the UK who are initiating or switching biologics, specifically anti-TNFα and anti-α4β7 integrin for UC, and anti-TNFα, antibodies to p40 subunit of IL-12/2 and JAKi for CD. Through comprehensive profiling of immunological, transcriptional, microbiome, genetic and proteomic markers at baseline, week 12, and week 52, this study aims to uncover non-invasive biomarkers that predict response to these drug classes, ultimately advancing personalised medicine in IBD.
Ethical approval for the Nottingham/AstraZeneca study was granted by the West of Scotland Research Ethics Committee. Recruitment began in December 2022 and is currently ongoing at 10 NHS Trust sites across the UK. Study findings will be disseminated by publication in peer-reviewed journals and presentations at relevant national and international conferences.
This study aimed to investigate the knowledge, attitude and practice (KAP) of patients living with functional gastrointestinal disorders (FGIDs) toward their diseases.
A web-based cross-sectional study was conducted.
The gastroenterology outpatient department of Zhejiang Hospital of Traditional Chinese Medicine, Zhejiang, China.
The study enrolled 503 patients with FGIDs from the Gastroenterology Outpatient Department of our hospital between September and October 2023.
Not applicable for cross-sectional study.
Participants completed a self-designed questionnaire that collected sociodemographic information and assessed KAP scores. The primary outcome measures were KAP scores.
The mean KAP scores were 6.57±2.76 (possible range: 0–10) for knowledge, 30.00±4.08 (possible range: 7–35) for attitude and 30.16±4.92 (possible range: 8–40) for practice. Pearson’s correlation analysis indicated a positive and moderate correlation between knowledge and attitude (r=0.330, p
Patients with FGIDs demonstrated moderate knowledge, positive attitudes and moderate practices regarding their disease. Drinking habits and household income reportedly influenced their KAP outcomes. Targeted educational interventions are warranted to enhance practice behaviours among patients with FGIDs.
FreshRSS 