Same-visit endoscopic ultrasound plus ERCP for pancreaticobiliary conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center randomized controlled trial will enroll adults indicated for ERCP and randomize them 1:1 to same-session EUS plus ERCP versus ERCP alone. Clinical data and patient-reported outcomes are collected at baseline and during follow-up, and a structured questionnaire will record whether EUS changed the planned ERCP strategy. Secondary comparisons include complication rates, technical success, hospitalization costs, length of stay, and radiation exposure. Outcomes will be compared between groups to determine the safety and practical impact of adding same-session EUS.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients aged ≥18 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.

Where it's running

• Qilu Hospital of Shandong University
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Zhen Li, MD,PhD
• Email: qilulizhen@sdu.edu.cn
• Phone: +86 18560086106

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.