Effect of Same-session EUS on ERCP in Pancreaticobiliary Diseases: A Randomized Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Pancreaticobiilary Diseases

• Registration Number: NCT06978231
• Lead Sponsor: Qilu Hospital of Shandong University

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-05
• Study First Submitted: 2025-05-10
• Study First Submitted QC: 2025-05-16
• Last Update Submitted: 2025-05-16
• Study First Posted: 2025-05-18
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-12
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

1. Patients aged 18-80 years;
2. Patients with pancreaticobiliary diseases definitively indicated for ERCP (as confirmed by HBP Specialists );
3. No prior history of ERCP;
4. No pancreaticobiliary EUS examinations within the preceding 3 months.

Exclusion Criteria

1. Patients with clinically confirmed malignant lesions deemed surgically unresectable by multidisciplinary evaluation and requiring pathological diagnosis exclusively for chemotherapy/radiotherapy guidance;
2. Patients with confirmed diagnosis requiring only palliative biliary/pancreatic stent placement for obstructive jaundice ;
3. Patients with anatomical alterations or surgical history affecting EUS feasibility;
4. Severe systemic illness including severe hepatic, renal, cardiopulmonary and cerebrovascular diseases with high risk for endoscopic procedures;
5. Contraindication to iodinated contrast media (allergy or renal impairment preventing ERCP);
6. Pregnancy or lactation;
7. Patients with severe coagulopathy;
8. Declined informed consent;
9. Severe psychiatric disorder/non-cooperation precluding safe procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ERCP management strategy modification	From enrollment to 6 months after the end of treatment

Secondary Outcome Measures

Name	Time	Method
Procedure outcomes	From enrollment to 6 months after the end of treatment	Technical success rate (defined as successful completion of intended therapeutic intervention) ERCP procedure time (from duodenoscope insertion to withdrawal) Difficult cannulation rate (requiring advanced techniques or \>5 attempts)
Incidence of complications	From enrollment to 6 months after the end of treatment
Radiation-related situation	From enrollment to 6 months after the end of treatment	Fluoroscopy time (minutes) Radiation exposure (dose-area product, Gy·cm²)
Healthcare utilization measures	From enrollment to 6 months after the end of treatment	Hospital length of stay (days) Total hospitalization costs

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China