Effect of Same-session EUS on ERCP in Pancreaticobiliary Diseases
Effect of Same-session Endoscopic Ultrasonography on Endoscopic Retrograde Cholangiopancreatography in Pancreaticobiliary Diseases: A Randomized Controlled Trial
Qilu Hospital of Shandong University
214 participants
Jun 10, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria9
- 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);
- Pregnancy or lactation;
- Patients with severe coagulopathy;
- Declined informed consent;
- Severe psychiatric disorder/non-cooperation precluding safe procedure.
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Interventions
EUS were performed during the same session with ERCP under continuous sedation/anesthesia
Only ERCP was performed in the control group
Locations(1)
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NCT06978231