Effect of Same-session EUS on ERCP in Pancreaticobiliary Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EUS+ERCP, ERCP.
- Who it may be relevant to
- Registry conditions: Pancreaticobiilary Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Same-session Endoscopic Ultrasonography on Endoscopic Retrograde Cholangiopancreatography in Pancreaticobiliary Diseases: A Randomized Controlled Trial
Overview
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.
Interventions
- Procedure EUS+ERCP
EUS were performed during the same session with ERCP under continuous sedation/anesthesia - Procedure ERCP
Only ERCP was performed in the control group
Primary outcome measures
- ERCP strategy modification rate [Time frame: From enrollment to 6 months after the end of treatment]
Secondary outcome measures (4)
- Procedure outcomes [Time frame: From enrollment to 6 months after the end of treatment]
- 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]
- Healthcare utilization measures [Time frame: From enrollment to 6 months after the end of treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Qilu Hospital of Shandong University — Jinan
Identifiers
NCT: NCT06978231 · 2025SDU-QILU-3