United European Gastroenterology Journal最新文献

Objective: The objective of this study was to investigate the efficacy of transcutaneous auricular vagal nerve stimulation (taVNS) in adult patients with chronic constipation.

Design: Consecutive patients who met the Rome IV criteria for chronic constipation were enrolled and randomly assigned to either the taVNS group or the sham-taVNS group. Treatment consisted of 30 min of therapy twice a day for 4 weeks. The primary outcome was the response rate at week 1-4, defined as the proportion of patients with a weekly complete spontaneous bowel movement (CSBM) of ≥ 3 and weekly excessive use of rescue medication ≤ 3 times. Secondary outcomes included spontaneous bowel movements, anxiety and depression scores, abdominal symptoms, and adverse events.

Results: The study was terminated due to lack of efficacy revealed by the interim analysis. A total of 106 patients were randomized, with 52 participants in the taVNS group and 54 participants in the sham-taVNS group. After 4 weeks of treatment, the response rates were 17% (9/52) in the taVNS group and 19% (10/54) in the sham-taVNS group. There was no significant difference between the two groups in intention-to-treat (ITT) analysis (RR 0.92, 95% CI 0.30-2.80, p = 1) or in the per-protocol (PP) analysis. No serious adverse events were reported.

Conclusion: Our study did not support the effectiveness of 4-week 25 Hz taVNS for the treatment of adult chronic constipation patients.

Trial registration: clinicaltrials.gov number: NCT05723731.

Background: Crohn's disease (CD) is an incurable inflammatory bowel disease that can lead to a variety of complications and requires lifelong treatment. However, the diagnosis and management of Crohn's disease exhibit high rates of misdiagnosis and missed diagnoses, along with significant variability, among primary care facilities and novice endoscopists. Therefore, we established an interpretable artificial intelligence (AI) system using double-balloon enteroscopy to facilitate Crohn's disease ulcer identification and grading.

Objective: To develop an interpretable AI system for the identification and grading of Crohn's disease ulcer images, offering bounding box localization for visual interpretability and factor-specific grading explanations for each ulcer to improve assessment performance.

Methods: We constructed a region and grading model of individual ulcers based on the YOLO-v5 algorithm. By analyzing the predicted results of all ulcers in each image, the clinical interpretation for the screening and assessment of Crohn's disease ulcer images was further achieved. To evaluate the system, we prepared the training and validation datasets (17,036 double-balloon enteroscopy images, 558 patients) and further collected a test cohort (2018 images, 70 patients) and an external validation set. A further reader study was conducted on the internal test set in which nine endoscopists participated to evaluate the auxiliary effectiveness of the explainable system.

Results: The Crohn's disease ulcer image detection sensitivity and area under the curve (AUC) were 91.8% and 0.949. The accuracies in assessing the severity of Crohn's disease ulcer images on three factors (size/ulcerated surface/depth) were 94.1%/92.5%/93.0%, respectively. With the system's support of visualized and analyzable predictions, junior endoscopists improved their Crohn's disease ulcer image recognition sensitivity by 12.7% and their accuracy and consistency of severity assessment by 26% and 27.4%.

Conclusion: The AI system outperformed general endoscopists in approaching expert-level proficiency in Crohn's disease ulcer identification and assessment. Its transparency in decision-making facilitated integration into clinical workflows, enhancing trust and consistency among endoscopists.

Introduction: Pancreatic exocrine insufficiency (PEI) results from a reduction in pancreatic secretion of enzymes, leading to malabsorption of nutrients, intestinal symptoms, nutritional deficiencies and related comorbidities. The diagnosis of pancreatic exocrine insufficiency should be based on digestive tests, mainly the coefficient of fat absorption (CFA), based on the quantification of 72 h fecal fat excretion (FFE). However, this test is rarely performed in clinical practice. Fecal elastase-1 (FE-1) is a simple and widely used alternative. This meta-analysis evaluates the diagnostic accuracy of fecal elastase-1 for the diagnosis of PEI diagnosed by CFA or 72h-FFE.

Methods: A systematic search of databases was performed to identify studies evaluating fecal elastase-1 and CFA/FFE for the diagnosis of pancreatic exocrine insufficiency. Inclusion criteria required original studies with data on sensitivity, specificity and other diagnostic metrics. Two independent reviewers performed data extraction and quality assessment using the QUADAS-2 tool. Pooled sensitivity, specificity, likelihood ratios and diagnostic odds ratio (DOR) were calculated and heterogeneity was assessed using I-squared tests.

Results: Thirteen studies with 888 patients were included. Fecal elastase-1 at a cut-off of 200 μg/g showed a pooled sensitivity and specificity of 0.94 and 0.69, respectively, with a DOR of 35.27. Lowering the cut-off to 100 μg/g improved specificity to 0.82 but decreased sensitivity to 0.88. Subgroup analyses showed different diagnostic performance in different clinical contexts, with higher sensitivity in cystic fibrosis (0.98) and higher specificity in chronic pancreatitis (0.81). The positive and negative predictive values are limited in situations with low and high probability of pancreatic exocrine insufficiency, respectively.

Conclusions: Fecal elastase-1 is a sensitive and moderately specific diagnostic tool for pancreatic exocrine insufficiency and is suitable for initial screening in high-risk populations. However, its moderate specificity requires careful interpretation in lower risk settings.

Background: Vonoprazan and amoxicillin dual therapy has demonstrated favorable efficacy in the initial treatment of Helicobacter pylori (H. pylori) infection. This study aimed to evaluate the efficacy and safety of vonoprazan and high-dose amoxicillin (VHA) dual therapy for H. pylori rescue treatment.

Methods: This was an open label, multicenter, non-inferiority, and randomized controlled clinical trial conducted at four institutions in both central and northwestern China. A total of 688 H. pylori-infected patients who had failed previous treatments were randomly assigned (1:1) to receive either VHA dual therapy or the tetracycline- and furazolidone-based bismuth-containing quadruple therapy (TFEB) for 14 days. Eradication rates, adverse event (AE) rates, and the patient compliance were compared between the two groups.

Results: The eradication rates in the VHA and TFEB groups were 73.8% and 76.2% (p = 0.481), respectively, by intention-to-treat (ITT) analysis; 81.9% and 85.6% (p = 0.215), respectively, by modified ITT (MITT) analysis; and 82.1% and 85.6% (p = 0.248), respectively, by per-protocol (PP) analysis. VHA therapy remained non-inferior to TFEB in ITT, MITT, and PP analyses. The overall AE incidence in the VHA group was significantly lower compared with that in the TFEB group (13.4% vs.. 28.5%, p < 0.001). Patients' compliance was similar between the two groups. A history of multiple prior eradication failures was an independent risk factor (2 failures: OR = 0.566, p = 0.032; ≥ 3 failures: OR = 0.335, p < 0.001) reducing the efficacy of H. pylori rescue therapy.

Conclusion: The 14-day VHA dual therapy was non-inferior to bismuth-containing quadruple therapy, with a lower incidence of adverse events and good compliance, and may represent an effective alternative for H.pylori rescue treatment.

Trial registration: This trial was registered at ClinicalTrials.gov (No. NCT06168084).

Introduction: Perianal Crohn's disease (CD) remains challenging to treat despite the increasing number of advanced therapies. Advanced dual-targeted therapy has emerged as a new treatment option in CD, but no data are available for perianal CD. The aim of this study was to evaluate the effectiveness and safety of advanced dual-targeted therapy for anoperineal fistulas (APFs) in CD patients.

Materials and methods: We prospectively included all consecutive patients receiving an advanced dual-targeted therapy for APFs from August 2019 to December 2023 in a single tertiary perianal CD centre. The primary outcome was clinical effectiveness. Secondary outcomes were patients' treatment perception, radiological effectiveness, luminal disease effectiveness, impact on extra-intestinal manifestations, and safety. Factors associated with complete clinical remission of APFs were identified using logistic regression.

Results: A total of 33 patients were included. The most frequently used advanced dual-targeted therapy was a combination of infliximab and ustekinumab (75.8%). After a median follow-up of 27.4 months, 48.5% and 97.0% of patients were in complete clinical remission and reported a perceived improvement, respectively. Complete radiological remission was achieved in 24.2% of the patients. A concomitant improvement in luminal intestinal involvement was observed in 46.1% of cases, and in extra-digestive manifestations in 45.8% of cases. Treatment tolerance was considered good or very good in 90.9% of cases. Associated anal ulcers and long-term exposure to antibiotics were associated with a lower likelihood of complete clinical remission for fistulas.

Conclusion: These findings suggest that advanced dual-targeted therapy is a valid option with a good safety profile for the treatment of refractory APFs. Larger studies are required to identify the most effective combination.

Background and aims: Dye-based chromoendoscopy (DCE) has been the preferred method for colonoscopy surveillance in patients with inflammatory bowel disease (IBD). However, with advances in endoscopy, virtual chromoendoscopy (VCE) techniques have emerged. This network meta-analysis evaluates the effectiveness of different endoscopy techniques for IBD patient surveillance.

Methods: Sixteen randomized controlled trials involving 2514 patients were included in the analysis, comparing endoscopy techniques in IBD patient surveillance: DCE, high-definition white light endoscopy (WLE), standard-definition WLE, i-scan, narrow band imaging (NBI), flexible spectral imaging color enhancement (FICE), and autofluorescence imaging (AFI). We assessed the per patient neoplasia detection rate, positive predictive value (PPV), and withdrawal time between different endoscopy techniques. Moreover, subgroup analysis was conducted to investigate the neoplasia detection rate according to endoscopy techniques using various biopsy protocols.

Results: Comparing neoplasia detection rates revealed that only DCE (OR: 2.56 [1.17-5.59]) significantly increased the neoplasia detection rate compared with standard-definition WLE. The subsequent rankings were high-definition WLE, NBI, FICE, i-scan, and AFI. Moreover, the PPVs of DCE, VCE, and high-definition WLE showed no significant difference compared with that of standard-definition WLE. However, DCE required a significantly longer withdrawal time. Subgroup analysis showed that DCE with random biopsy or target biopsy and high-definition WLE with target biopsy had superior neoplasia detection rates than standard-definition WLE with random biopsy.

Conclusion: DCE significantly outperforms standard-definition WLE in neoplasia detection rates, with random biopsy providing additional benefits. Although DCE does not lower PPV, it requires more withdrawal time. If DCE-based surveillance is not feasible, high-definition WLE with targeted biopsy should be considered as other VCE techniques offer no significant advantages.