Effect of Same-session EUS on ERCP in Pancreaticobiliary Diseases

NCT ID: NCT06978231

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-10
• Study Completion Date: 2027-04-30

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.

Conditions

Pancreaticobiilary Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EUS+ERCP group

EUS and ERCP were performed during the same session under continuous sedation/anesthesia in the intervention group.

Group Type: EXPERIMENTAL

EUS+ERCP

Intervention Type: PROCEDURE

EUS were performed during the same session with ERCP under continuous sedation/anesthesia

ERCP group

Only ERCP was performed in the control group

Group Type: OTHER

ERCP

Intervention Type: PROCEDURE

Only ERCP was performed in the control group

Interventions

EUS+ERCP

EUS were performed during the same session with ERCP under continuous sedation/anesthesia

Intervention Type: PROCEDURE

ERCP

Only ERCP was performed in the control group

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhen Li, MD,PhD

Role: CONTACT

qilulizhen@sdu.edu.cn

+86 18560086106

Facility Contacts

Zhen Li, MD

Role: primary

lizhenh@hotmail.com

18560086106

Other Identifiers

2025SDU-QILU-3

Identifier Type: -

Identifier Source: org_study_id