Same-visit endoscopic ultrasound plus ERCP for pancreaticobiliary conditions
Effect of Same-session Endoscopic Ultrasonography on Endoscopic Retrograde Cholangiopancreatography in Pancreaticobiliary Diseases: A Randomized Controlled Trial
We will test whether doing endoscopic ultrasound (EUS) during the same visit as ERCP changes the procedure plan and improves outcomes for adults with pancreaticobiliary diseases.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06978231 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older who are newly indicated for ERCP, have not had prior ERCP, and have not had pancreaticobiliary EUS within the past three months are ideal candidates.
Not a fit: Patients with unresectable malignancies needing only pathological confirmation, those requiring only palliative stenting, people with anatomy that prevents EUS, severe comorbid conditions, contrast allergy, or pregnancy are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding same-session EUS could help doctors choose better ERCP approaches during a single visit, potentially reducing complications, shortening hospital stays, and lowering radiation exposure and costs.
How similar studies have performed: Observational studies and small prospective reports indicate same-session EUS can alter management and appear safe, but randomized controlled data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jinan, Shandong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.