Status:
RECRUITING
Effect of Same-session EUS on ERCP in Pancreaticobiliary Diseases
Lead Sponsor:
Qilu Hospital of Shandong University
Conditions:
Pancreaticobiilary Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT06978231
Start Date
June 10 2025
End Date
April 1 2027
Last Update
September 9 2025
Active Locations (1)
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1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250000