Effect of Same-session Endoscopic Ultrasonography on Endoscopic Retrograde Cholangiopancreatography in Pancreaticobiliary Diseases: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Qilu Hospital of Shandong University
RECRUITING
Jinan
Contact Information
Primary
Zhen Li, MD,PhD
qilulizhen@sdu.edu.cn
+86 18560086106
Time Frame
Start Date: 2025-06-10
Estimated Completion Date: 2027-04
Participants
Target number of participants: 214
Treatments
Experimental: EUS+ERCP group
EUS and ERCP were performed during the same session under continuous sedation/anesthesia in the intervention group.
Other: ERCP group
Only ERCP was performed in the control group
Related Therapeutic Areas
Sponsors
Leads: Qilu Hospital of Shandong University

This content was sourced from clinicaltrials.gov