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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
214
EUS were performed during the same session with ERCP under continuous sedation/anesthesia
Only ERCP was performed in the control group
Qilu Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGERCP strategy modification rate
Concordance rate between anticipated and actual ERCP procedural strategies and the rate of avoiding unnecessary ERCP procedures.
Time frame: From enrollment to 6 months after the end of treatment
Procedure outcomes
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)
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
Fluoroscopy time (minutes) Radiation exposure (dose-area product, Gy·cm²)
Time frame: From enrollment to 6 months after the end of treatment
Healthcare utilization measures
Hospital length of stay (days) Total hospitalization costs
Time frame: From enrollment to 6 months after the end of treatment
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