Clinical trial NCT06978231: Effect of Same-session EUS on ERCP in Pancreaticobiliary Diseases: A Randomized Controlled Trial
Official title: Effect of Same-session Endoscopic Ultrasonography on Endoscopic Retrograde Cholangiopancreatography in Pancreaticobiliary Diseases: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreaticobiilary Diseases
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: ERCP management strategy modification
timeFrame: From enrollment to 6 months after the end of treatment
Secondary outcomes:
measure: Procedure outcomes
timeFrame: From enrollment to 6 months after the end of treatment
measure: Incidence of complications
timeFrame: From enrollment to 6 months after the end of treatment
measure: Radiation-related situation
timeFrame: From enrollment to 6 months after the end of treatment
measure: Healthcare utilization measures
timeFrame: From enrollment to 6 months after the end of treatment
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References: