Qilu Hospital of Shandong University
Jinan, Shandong, 250000, China
Location status: Recruiting
Recruiting
NCT Number: NCT06978231
Effect of Same-session EUS on ERCP in Pancreaticobiliary Diseases
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- Patients with clinically confirmed malignant lesions deemed surgically unresectable by multidisciplinary evaluation and requiring pathological diagnosis exclusively for chemotherapy/radiotherapy guidance;
- Patients with confirmed diagnosis requiring only palliative biliary/pancreatic stent placement for obstructive jaundice ;
- Patients with anatomical alterations or surgical history affecting EUS feasibility;
- Severe systemic illness including severe hepatic, renal, cardiopulmonary and cerebrovascular diseases with high risk for endoscopic procedures;
- Contraindication to iodinated contrast media (allergy or renal impairment preventing ERCP);
- Pregnancy or lactation;
- Patients with severe coagulopathy;
- Declined informed consent;
- Severe psychiatric disorder/non-cooperation precluding safe procedure.
Treatment and study plan
EUS+ERCP
ProcedureEUS were performed during the same session with ERCP under continuous sedation/anesthesia
ERCP
ProcedureOnly ERCP was performed in the control group
Primary outcomes
-
ERCP strategy modification rate
Time frame: From enrollment to 6 months after the end of treatment
Concordance rate between anticipated and actual ERCP procedural strategies and the rate of avoiding unnecessary ERCP procedures.
Secondary outcomes
-
Procedure outcomes
Time frame: From enrollment to 6 months after the end of treatment
Technical success rate (defined as successful completion of intended therapeutic intervention) ERCP procedure time (from duodenoscope insertion to withdrawal) Difficult cannulation rate (requiring advanced techniques or >5 attempts)
-
Incidence of complications
Time frame: From enrollment to 6 months after the end of treatment
-
Radiation-related situation
Time frame: From enrollment to 6 months after the end of treatment
Fluoroscopy time (minutes) Radiation exposure (dose-area product, Gy·cm²)
-
Healthcare utilization measures
Time frame: From enrollment to 6 months after the end of treatment
Hospital length of stay (days) Total hospitalization costs
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Qilu Hospital of Shandong University
Other
Registry information
Official study title
Effect of Same-session Endoscopic Ultrasonography on Endoscopic Retrograde Cholangiopancreatography in Pancreaticobiliary Diseases: A Randomized Controlled Trial
Acronym: EUS、 ERCP
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- May 18, 2025
- Registry last updated
- Sep 9, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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