Effect of Same-session EUS on ERCP in Pancreaticobiliary Diseases (NCT06978231) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Same-session EUS on ERCP in Pancreaticobiliary Diseases
China214 participantsStarted 2025-06-10
Plain-language summary
This is a single-center randomized controlled trial. Eligible subjects meeting inclusion/exclusion criteria will be randomized 1:1 to EUS+ERCP group or ERCP group. Clinical data and patient-reported outcomes are regularly collected at baseline and during follow-up periods. A comparative analysis was conducted to assess the impact of same-session EUS on ERCP strategy modification between two groups, utilizing a structured questionnaire.Secondarily, the safety and efficacy of same-session EUS will be comprehensively evaluated by comparing complication rates, technical success rate and hospitalization costs, length of stay, and radiation exposure between groups.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients aged ≥18 years;
✓. Patients with pancreaticobiliary diseases definitively indicated for ERCP (as confirmed by HBP Specialists );
✓. No prior history of ERCP;
✓. No pancreaticobiliary EUS examinations within the preceding 3 months.
Exclusion criteria
✕. Patients with clinically confirmed malignant lesions deemed surgically unresectable by multidisciplinary evaluation and requiring pathological diagnosis exclusively for chemotherapy/radiotherapy guidance;
✕. Patients with confirmed diagnosis requiring only palliative biliary/pancreatic stent placement for obstructive jaundice ;
✕. Patients with anatomical alterations or surgical history affecting EUS feasibility;
✕. Severe systemic illness including severe hepatic, renal, cardiopulmonary and cerebrovascular diseases with high risk for endoscopic procedures;
✕. Contraindication to iodinated contrast media (allergy or renal impairment preventing ERCP);
What they're measuring
1
ERCP strategy modification rate
Timeframe: From enrollment to 6 months after the end of treatment