Conectar
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.
Radioembolisation (RE) is gaining traction as a robust treatment option for patients with hepatocellular cancer (HCC) across all cancer stages. RE allows the delivery of targeted high-dose radiation directly to tumours, with relative sparing of the surrounding liver tissue. Traditionally, radiation has been delivered using 90Yttrium ([90Y]Y)-labelled microspheres, either glass or resin. The success of RE is dependent on the dose delivered to the tumour. When using [90Y]Y microspheres, dose prediction is calculated through a 99mTechnitium ([99mTc]Tc)-macroaggregated albumin (MAA) scan, which allows the calculation of the dose to be administered to the tumour. However, [99mTc]Tc-MAA is not a true surrogate of [90Y]Y microspheres, and this will impact on the final dose delivered. [166Ho]Ho, like [90Y]Y, is a beta emitter but unlike [90Y]Y also emits gamma-radiation, allowing for quantitative nuclear imaging. The primary aim of this pilot study was to investigate the safety and efficacy of dosimetry-based individualised 166Holmium ([166Ho]Ho-RE) in patients with HCC.
15 eligible participants will be recruited to receive [166Ho]Ho-RE. The primary objective is to establish the toxicity profile of dosimetry-based individualised [166Ho]Ho-RE. The secondary objective is to assess efficacy as measured by modified Response Evaluation Criteria in Solid Tumours (mRECIST) and Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria. Additional exploratory objectives include quality of life assessment and identification of a radiomic signature of response. The results from this study will be combined with the prospective iHEPAR study to form a larger analysis.
The study has received approval from the East Midlands—Nottingham 1 Research Ethics Committee—approval number 23/EM/0239. The study will be performed in compliance with the Declaration of Helsinki and the principles of Good Clinical Practice. Signed informed consent will be obtained from each patient before study entry. The results will be disseminated through publication in a peer-reviewed scientific journal.
Clinicaltrials.gov NCT06302400.
To identify novel, data-driven phenotypic clusters of metabolic dysfunction-associated fatty liver disease (MAFLD) and investigate their associations with cardiac remodelling.
Cross-sectional study.
Secondary care; a single-centre study in China.
A total of 3233 participants diagnosed with MAFLD were included in the study. The diagnosis was conducted in accordance with the established criteria for MAFLD. The exclusion criteria encompassed a history of significant cardiovascular or hepatic diseases, as well as excessive alcohol consumption.
Echocardiographic parameters of cardiac structure and function.
Four distinct clusters were identified. Cluster 1 (n=1381) comprised men with a normal metabolic state and low Fibrosis-4 Index (FIB-4) levels. Cluster 2 (n=453) included men with the highest body mass index (BMI) and uric acid levels. Cluster 3 (n=474) consisted of men with the most severe glucose and lipid metabolic disturbances. Cluster 4 (n=925) comprised women with the highest FIB-4 levels. Compared with Cluster 1, participants in Clusters 2 and 3 exhibited worse cardiac structure and function, including enlargement of the left atrium (LA), right atrium, left ventricular internal end-diastolic dimension, interventricular septum (IVS), left ventricular posterior wall (LVPW) thickness, right ventricular and reduced left ventricular ejection fraction. Conversely, participants in Cluster 4 had better cardiac structure and function compared with those in Cluster 1. After adjusting for confounders, Cluster 2 showed positive associations with the LA, IVS, LVPW, right atrium and right ventricular (all p
The heterogeneity of MAFLD reveals sex-specific patterns of cardiac remodelling: male phenotypes with high BMI and uric acid levels are associated with worse remodelling, whereas a female phenotype characterised by high FIB-4 levels correlates with preserved cardiac function.
To evaluate the association between metabolic dysfunction-associated steatotic liver disease (MASLD), metabolic-associated steatohepatitis (MASH), and the risk of colorectal cancer (CRC) and benign colorectal neoplasms (BCN), and to explore whether liver fibrosis/cirrhosis modifies these associations.
Retrospective cohort study with 1:1 propensity score matching.
Global, multicentre real-world analysis using deidentified electronic health records from over 130 healthcare organisations in the TriNetX Global Collaborative Network.
Hospitalised adults aged 45–75 years between October 2019 and October 2024. Patients with prior diagnoses of colorectal neoplasia or other chronic liver diseases were excluded. Final matched cohorts included 138 902 MASLD and non-MASLD patients, 3715 MASH and non-MASH patients, and 1312 MASH patients with and without fibrosis.
Primary outcomes: Incidence of CRC and BCN. Secondary outcome: Combined incidence of CRC and BCN. Outcomes were assessed with and without controlling for metabolic risk factors using Cox proportional hazards models.
MASLD was associated with increased risks of CRC (HR 2.71, 95% CI 2.29 to 3.20) and BCN (HR 2.50, 95% CI 2.38 to 2.63), both p
MASLD and MASH are independent risk factors for CRC and BCN, irrespective of metabolic comorbidities. Fibrosis/cirrhosis does not significantly influence CRC risk. These findings support the need to revisit CRC screening guidelines for patients with MASLD/MASH. Further prospective studies are warranted to explore underlying mechanisms and evaluate preventative interventions.
Functional constipation (FC) is prevalent among children and often persists despite standard pharmacological treatment with oral laxatives. Many parents turn to complementary therapies, including acupuncture, which has been shown to relieve symptoms in adults with FC. However, studies in children with FC are scarce and have important limitations. This study will evaluate the feasibility, safety and potential efficacy of acupuncture for children with FC.
Prospective, non-randomised, open-label pilot study in children with FC (6–18 years). Participants will undergo eight acupuncture sessions over 10 weeks. Concurrent pharmacological treatment with polyethylene glycol (≥0.2 g/kg/day) will continue as initiated prior to enrolment. The primary endpoint is feasibility, defined by an attrition rate of ≥70%. Secondary feasibility endpoints include consent rate, patient/parent satisfaction and personnel requirements. Safety will be assessed by systematic monitoring of adverse events. Efficacy endpoints include treatment success, defined as no longer meeting the Rome IV criteria for FC at the end of the intervention period, as well as defecation frequency, stool consistency, painful defecation, faecal incontinence frequency, abdominal pain, medication use and quality of life, based on a previously published core outcome set.
Ethical approval was provided by the Medical Ethics Committee of Amsterdam UMC (Netherlands; NL87083.018.24). Results will be published in peer-reviewed journals and presented to scientific and consumer audiences.
NCT06836362 and NL-OMON57236.
Lynch syndrome (LS) carriers have a 20–46% lifetime risk of colorectal cancer (CRC) due to mismatch repair gene variants. Mesalamine (5-ASA, 5-aminosalicylic acid), used safely in patients with ulcerative colitis, may reduce CRC risk in LS by decreasing microsatellite instability, a key driver of LS-related cancer. This study evaluates 5-ASA’s efficacy as a tolerable chemopreventive drug, aiming to improve long-term CRC prevention in LS.
This multicentre, multinational, randomised, double-blind, two-arm, phase II clinical study will compare the effects of a 2-year daily intake of 5-ASA (2000 mg) to placebo in LS carriers. The primary objective is to assess whether mesalamine reduces colorectal neoplasia, both benign and malignant, compared with placebo in LS carriers, as detected by colonoscopy at the end of the treatment period (24 months±1 month) and on study completion. Secondary objectives include evaluating whether 5-ASA reduces neoplasia/tumour multiplicity and progression compared with placebo at specified time points, examining variations in the effects of 5-ASA versus placebo based on cancer history, sex and age (
The trial is currently open for enrolment, having received ethical approval from the Regional Ethical Review Board in Stockholm and funding from the Swedish Research Council. The study protocol is the finalised V.10.0 (11 April 2024), transitioned to the European Clinical Trials Information System. LS remains underdiagnosed, which may limit recruitment. The results are of global interest and will be published in peer-reviewed journals and presented at scientific conferences.
ClinicalTrials.gov: NCT04920149. EudraCT: 2019-003011-55. EU CT: 2024-514765-19-01.
Economic evaluations in healthcare can guide practice and inform policy. The objective of this paper is to present the protocol for a health economic evaluation comparing the cost-effectiveness of prophylactic treatment using pantoprazole 40 mg daily compared with no pantoprazole to prevent upper gastrointestinal (GI) bleed among invasively ventilated patients.
This is an economic evaluation conducted alongside the
The trial was approved by each participating institution; this economic evaluation was approved by the Hamilton Integrated Research Ethics Board. Given widespread daily use of proton pump inhibitors for critically ill patients, the results of this economic evaluation will be of high relevance to patients, family members, physicians, pharmacists, policymakers and guideline developers. Integrated knowledge translation will involve periodic progress reports to collaborators. End-of-study knowledge translation will include rounds, videoconferences, abstracts and slide-decks for intensive care unit quality councils and healthcare organisations, and open-access publications. Patient and family partners will co-create lay language summaries for traditional and social media to help inform all interest groups.
The widespread application of interleukin (IL) inhibitors for various conditions, including gastrointestinal, rheumatologic, dermatologic and pulmonary diseases, has raised concerns regarding the potential for hepatitis B virus reactivation (HBVr). However, the precise risk of HBVr remains unclear due to inconsistencies in existing research. This systematic review aims to quantify the risk of HBVr in patients receiving IL inhibitor therapies.
This systematic review will follow Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A comprehensive search will be conducted in MEDLINE, PubMed, Google Scholar, CENTRAL, Scopus, Embase, Web of Science and ClinicalTrials.gov up to October 2025. Two reviewers will independently screen studies and extract data, resolving discrepancies by consensus. Eligible studies will include HBV-infected patients receiving IL inhibitors. HBVr rates will be estimated using a generalised linear mixed model with a binomial distribution, applying random-effects models to account for interstudy variability. Heterogeneity will be assessed using I², Cochran’s Q and ². Leave-one-out sensitivity analyses will evaluate robustness. Subgroup analyses will consider HBV serostatus, IL inhibitor type and study characteristics. Studies including patients on antiviral prophylaxis will be excluded from the primary analysis. A secondary analysis will assess prophylaxis efficacy in preventing HBVr according to hepatitis B surface antigen status. Publication bias will be evaluated using Doi plots and the Luis Furuya-Kanamori index.
This study does not require ethics approval as it involves no patient-specific data. Findings will be disseminated at gastroenterology conferences and through peer-reviewed publications.
The protocol is registered in PROSPERO (CRD42024614179).
Hepatic encephalopathy (HE), a severe complication of decompensated cirrhosis, is characterised as neurocognitive dysfunction. Emerging evidence suggests the potential role of human albumin infusion for the treatment of HE, but its optimal dosage remains undefined. Therefore, we planned a randomised controlled trial (RCT) to compare the efficacy of human albumin infusion at different dosages in patients with liver cirrhosis and overt HE.
This RCT will be conducted in the Departments of Gastroenterology or Hepatology of 16 tertiary hospitals in China. Overall, 174 patients with a diagnosis of liver cirrhosis, overt HE and a serum albumin level of 23–30 g/L will be enrolled. They will be stratified according to the severity of overt HE and randomly assigned at a ratio of 1:1 into the groups of human albumin infusion at a modified dosage and a routine dosage. The primary end point is the improvement of overt HE within 3–5 days after treatment. The secondary end points include recurrence of overt HE, survival and adverse events. We expect that this RCT will provide high-quality evidence on the optimal dosage of human albumin infused, which can achieve more clinical benefits to patients with liver cirrhosis and overt HE.
The study has been approved by the Medical Ethical Committee of the General Hospital of Northern Theater Command (ethical approval number Y2024-148). The study findings will be published in academic journals.
Disease activity assessment is important for Crohn’s disease (CD) management, since it involves the initial and subsequent therapeutic schedule. The purpose of this study is to identify a portable and reliable indicator for assessing and predicting activity and severity of CD.
A multicentre, cross-sectional, diagnosis-based study. Data were obtained retrospectively from clinical records.
Patient data for the development cohort and internal validation cohort were collected from the Department of Gastroenterology, Xiangya Hospital, Central South University between January 2017 and June 2021. Patient data for the external validation cohort were collected from the Department of Gastroenterology, Xiangtan Central Hospital between January 2022 and April 2024.
Inpatients diagnosed with CD were potential participants, and those with CD who also had other autoimmune diseases, malignant tumours, pregnancy or lactation were excluded. We identified 224 patients in the development cohort, 96 patients in the internal validation cohort and 80 patients in the external validation cohort.
Demographic data and laboratory examination results were collected and seven integrated indices were established. Mann-Whitney U test, Kruskal-Wallis K test, 2 test and multivariate logistic regression analysis were used to identify independent predictors. Receiver operating characteristics curve analysis was used to evaluate the performance of integrated indices in CD activity and severity staging, and Delong’s test was used for comparison.
In the development cohort, platelet-to-albumin ratio (PAR) had the largest area under the curve (AUC) in prediction of activity (AUC of 0.753 (0.687–0.819), sensitivity 73.0%, specificity 68.4%, cut-off value 8.02) and was the only possible alternative in prediction of severity (AUC of 0.770 (0.693–0.848), sensitivity 81.2%, specificity 68.4%, cut-off value 9.71). Moreover, PAR demonstrated coherence in the internal validation cohort, effectively predicting activity (AUC 0.737 (0.639–0.835), sensitivity 65.7%, specificity 79.3%, positive predictive value (PPV) 88.0%, negative predictive value (NPV) 50.0%) and severity (AUC 0.720 (0.591–0.848), sensitivity 88.5%, specificity 77.4%, PPV 76.7%, NPV 64.9%). Furthermore, it showed generalisability in the external validation cohort for predicting activity (AUC 0.661 (0.536–0.785), sensitivity 61.9%, specificity 70.6%, PPV 88.6%, NPV 33.3%) and severity (AUC 0.752 (0.619–0.884), sensitivity 73.1%, specificity 64.9%, PPV 59.4%, NPV 77.4%).
PAR could be a portable index to assess the activity and severity of CD. Several limitations of this study, such as the limited sample size and potential biases, should be overcome in the future via more extensive validation.
Testing rates for hepatitis C virus (HCV) of new prison entrants vary considerably between prisons, with particularly low rates in category B male remand prisons. Improvement in testing rates will require an understanding of the underlying reasons.
To investigate the rates and uptake of testing for HCV in new entrants to three category B prisons in England and to use an implementation science framework to analyse the facilitators and barriers to meeting national standards for HCV testing in a prison healthcare environment.
This mixed-methods non-interventional study collated three data sets: anti-HCV testing uptake in prisons, plus data on the prior location of each individual (transfer from another prison or community) and their length of stay; a questionnaire designed to identify reasons for decline of a test administered to people in prison (PIP) who refused testing; qualitative interviews with key stakeholders in the process of prison HCV testing, with analysis based on the Consolidated Framework for Implementation Research (CFIR) to enable identification of barriers and facilitators to testing.
This study was conducted in the East Midlands region of England.
Data were obtained from three category B male remand prisons.
Primary outcome measures: This descriptive study sought to understand factors that influence anti-HCV test uptake in three English remand prisons. The selected prisons serve a combined population of 2.3 million and have the capacity to accommodate a total of 2030 prisoners. The testing rates within 4 weeks of arrival in the three prisons over a 12-month study period (March 2022–March 2023) were 17.2%, 28.3% and 42.5%. PIP were more likely to be tested if they arrived from the community compared with interprison transfer (39.13% vs 29.5%). Testing uptake rates increased with length of prison stay (12.4%, 33.6% and 40.7% for stays of 0–7, 15–21 and >28 days, respectively). The most common reasons for not accepting a test were a lack of interest and not wanting to be retested. 13 semistructured interviews revealed 21 barriers and 9 facilitators to testing, summarised in 5 overarching themes: misunderstanding of the concept of opt-out testing; nurses not meeting performance targets due to competing priorities; prison regime hampering healthcare delivery; absence of a specifically appointed co-ordinator who is held to account; incentivising nurses to test and PIP to accept testing.
The rates of testing for HCV in three category B male remand prisons were far below national standards. Key recommendations to improve testing rates, based on the CFIR analysis are (1) to appoint a dedicated senior healthcare staff member who combines responsibility, accountability and authority to proactively oversee testing and ongoing referral processes; (2) to reintroduce an education programme for prison healthcare teams to teach about HCV, cirrhosis and how to deliver ‘opt-out’ conversations and respond to typical responses and (3) to adopt more widely the strategy already shown to be successful in increasing test uptake by the Hepatitis C Trust HITT programme and offer simple incentives.
Cirrhosis is a major cause of morbidity and mortality. Patients with decompensated cirrhosis, or end-stage liver disease (ESLD), have a high symptom burden and an increased mortality risk. Yet, the uptake of palliative care in patients with ESLD remains low and variable. Despite robust evidence of the value of home palliative care in other advanced diseases, this has not been well studied in patients with ESLD. Hence, the primary aim of this study is to explore the implementation, feasibility and acceptability of home palliative care in patients with ESLD and healthcare professionals. We also aim to describe its impact on the quality of life (QoL), mood, symptom burden, caregiver burden and healthcare utilisation of patients with ESLD.
The study is a single-centre, mixed-methods feasibility study. Eligible patients include those with decompensated liver cirrhosis who are admitted under the gastroenterology and hepatology service and fulfil the Supportive and Palliative Care Indicator Tools (SPICT) criteria. Recruited patients will be followed up by a multi-disciplinary homecare team led by a palliative care physician for 6 months. Both qualitative and quantitative measures will be used to evaluate the primary aim and include the uptake of the service by both eligible patients and physicians. Semistructured interviews with key stakeholder groups will be conducted to determine their perspectives and experiences. Secondary outcome measures include changes in health-related QoL using the Chronic Liver Disease Questionnaire, depression severity, goals of care discussions, patient symptom burden, caregiver burden and healthcare utilisation.
This study will adhere to the Declaration of Helsinki and has been approved by the research ethics committee of the National Healthcare Group (DSRB (Domain Specific Review Board) reference: 2023/00852). Results will be submitted for publication in international peer-reviewed journals.
To compare colorectal neoplasm detection rates between patients with Streptococcus gallolyticus septicaemia and average-risk individuals undergoing screening colonoscopy and identify predictors of neoplasm detection within the septicaemia group.
A retrospective matched cohort study
Tertiary care university hospital in Southern Thailand.
Eighty-five patients with S. gallolyticus septicaemia and 279 average-risk individuals who underwent colonoscopy between 2014 and 2024.
Outcomes included the polyp detection rate (PDR), adenoma detection rate (ADR), advanced adenoma detection rate (aADR) and adenocarcinoma detection rate. Logistic regression was used to estimate ORs with 95% CIs.
In an unmatched analysis, the ADR (41.2% vs 26.9%, OR 1.90, 95% CI 1.15 to 3.16, p=0.014) and adenocarcinoma detection rate (12.9% vs 2.9%, OR 5.04, 95% CI 1.95 to 12.97, pafter the septicaemia episode was independently associated with a markedly higher likelihood of neoplasm detection than procedures done before septicaemia (adjusted OR 4.88, 95% CI 1.70 to 14.05, p=0.002), indicating that repeat colonoscopy may be warranted even in patients who had undergone the procedure within the previous 6 months.
S. gallolyticus septicaemia was linked to higher adenoma and adenocarcinoma detection rates, with age and diabetes mellitus further increasing such risk. Even patients who underwent colonoscopy within 6 months before septicaemia benefited from repeat colonoscopy, supporting its consideration to prevent missed or rapidly developing lesions.
Data on health inequalities in inflammatory bowel disease (IBD) among women of childbearing age (WCBA, 15–49 years) across different countries are lacking. We aimed to assess the global incidence, disability-adjusted life year (DALY) burden and cross-country inequalities of IBD in WCBA from 1990 to 2021.
Observational study.
Data were extracted from the Global Burden of Disease Study 2021.
Women aged 15–49 years diagnosed with IBD.
The primary outcomes were the total numbers and age-standardised rates of incidence and DALYs. Secondary outcomes included (1) temporal trends, assessed using estimated annual percentage change (EAPC); (2) periods of significant change identified through joinpoint regression analysis and (3) health inequalities by sociodemographic index (SDI), assessed using the slope index of inequality (SII) and the concentration index.
Globally, from 1990 to 2021, the number of incident IBD cases among WCBA increased from 60 926 (95% uncertainty interval (UI) 50 342 to 74 910) to 98 975 (95% UI 80 568 to 124 089), and DALYs increased from 193 091 (95% UI 145 850 to 245 244) to 281 580 (95% UI 223 989 to 349 966). During the same period, the age-standardised incidence rate (ASIR) increased significantly (EAPC 0.22, 95% UI 0.1 to 0.34), whereas the age-standardised DALY rate (ASDR) decreased significantly (EAPC –0.28, 95% UI –0.35 to –0.21). In 2021, the highest ASIR (14.93 per 100 000, 95% UI 11.52 to 18.97) and ASDR (27.94 per 100 000, 95% UI 19.97 to 37.87) were observed in high-SDI regions. In contrast, the fastest increase in ASIR (EAPC 1.69, 95% UI 1.48 to 1.90) occurred in middle-SDI regions. High-middle-SDI regions exhibited the most pronounced decrease in ASDR (EAPC –0.8, 95% UI –0.92 to –0.67), whereas a notable upward trend in ASDR was found solely in low-SDI regions (EAPC 0.14, 95% UI 0.07 to 0.21). The SII for ASIR increased from 4.83 (95% CI 3.63 to 6.03) in 1990 to 6.26 (95% CI 4.90 to 7.63) in 2021, whereas the concentration index decreased from 0.35 (95% CI 0.25 to 0.44) to 0.24 (95% CI 0.16 to 0.33). The SII for ASDR decreased from 7.37 (95% CI 2.07 to 12.67) in 1990 to 5.97 (95% CI 1.38 to 10.56) in 2021, and the concentration index shifted from 0.13 (95% CI 0.06 to 0.2) in 1990 to –0.03 (95% CI –0.1 to 0.05) in 2021.
In 2021, the global incidence and ASDR burden remained concentrated in high-SDI countries, with significant regional disparities. From 1990 to 2021, health inequality in DALYs gradually shifted from high-income to low-income countries.
Preoperative biliary drainage (PBD) is often required for patients with pancreatic cancer accompanied by biliary obstruction to ensure the safe administration of neoadjuvant chemotherapy or to manage cholangitis and jaundice. Although endoscopic retrograde cholangiopancreatography (ERCP) is the standard approach for PBD, it carries a significant risk of post-ERCP pancreatitis. Endoscopic ultrasound-guided biliary drainage (EUS-BD), particularly via hepaticogastrostomy (EUS-HGS), offers a promising alternative that avoids papillary manipulation. However, the clinical utility of EUS-BD as primary drainage for PBD remains unclear due to a lack of prospective studies. This multicentre prospective trial aims to evaluate the safety and efficacy of EUS-HGS as primary drainage for PBD in patients with resectable or borderline resectable pancreatic cancer.
This multicentre prospective study involves seven institutions in Japan. Eligible patients will undergo EUS-HGS using a 7Fr plastic stent. The primary endpoint is clinical success, defined by improvements in bilirubin or liver enzyme levels within 14 days postprocedure. Secondary endpoints include technical success rate, adverse event incidence, stent patency and surgical outcomes. A total of 30 patients will be enrolled, considering an expected clinical success rate of 90% and a 10% dropout allowance.
This study has been approved by the National Cancer Center Institutional Review Board (Research No. 2024-084). The results of this study will be reported at an international conference and published in an international peer-reviewed journal.
UMIN ID: 000055173.
The effect of prophylactic clipping for colorectal cold snare polypectomy (CSP) on delayed bleeding (DB) in patients with antithrombotic drugs remains unverified. The aim of the PERCOLD study is to demonstrate the non-inferiority of DB rates in cases without prophylactic clips compared with cases with prophylactic clips in patients taking antithrombotic drugs for colorectal CSP through randomised controlled trial (RCT).
This study is a multicentre prospective parallel-group RCT phase 3 trial that is being conducted at 14 institutions in Japan at the time of writing this manuscript. After providing consent, patients will undergo screening and assessment for study enrolment eligibility. Patients taking antithrombotic drugs (aged 20 years or older at the time of consent and who have agreed to participate in this study) will be selected if they have a preoperative suspected adenoma (including sessile serrated lesion) with an endoscopic diameter of
The trial protocol has been approved by the Chiba University Certified Clinical Research Reviewer Board (CRB3180015), which serves as the central ethics committee, and registered with Japan Registry of Clinical Trials. The current protocol V.1.7, dated 4 October 2024. Written informed consent for participation in the study will be obtained from all participating patients. All participating institutions have formally agreed to conduct the study in accordance with this central approval, and local site permissions were obtained as required by each institution. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences.
Japan Registry of Clinical Trials (jRCT1032230086).
FreshRSS 