Effect of Same-session Endoscopic Ultrasonography on Endoscopic Retrograde Cholangiopancreatography in Pancreaticobiliary Diseases: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 214
- Locations
- 1
- Primary Endpoint
- ERCP strategy modification rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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);
- •Pregnancy or lactation;
- •Patients with severe coagulopathy;
- •Declined informed consent;
- •Severe psychiatric disorder/non-cooperation precluding safe procedure.
Arms & Interventions
EUS+ERCP group
EUS and ERCP were performed during the same session under continuous sedation/anesthesia in the intervention group.
Intervention: EUS+ERCP (Procedure)
ERCP group
Only ERCP was performed in the control group
Intervention: ERCP (Procedure)
Outcomes
Primary Outcomes
ERCP strategy modification rate
Time Frame: From enrollment to 6 months after the end of treatment
Concordance rate between anticipated and actual ERCP procedural strategies and the rate of avoiding unnecessary ERCP procedures.
Secondary Outcomes
- Procedure outcomes(From enrollment to 6 months after the end of treatment)
- 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)
- Healthcare utilization measures(From enrollment to 6 months after the end of treatment)