Biliary Calculi Clinical Trial
Official title:
Balloon Catheter Versus Basket Catheter for Endoscopic Bile Duct Stone Extraction in Patients With Periampullary Diverticulum:a Multicenter Randomized Trial
Endoscopic bile duct stone (BDS) removal is a well-established treatment; however, the preference for basket or balloon catheters for extraction is operator-dependent It is reported that complete endoscopic treatment with a single catheter is more likely when choosing a balloon catheter over a basket catheter for extraction of BDSs≤10mm. However, a study comparing the two catheter types in patients with periampullary diverticulum has not been performed, and there is no strong basis on which to recommend the balloon catheter as a first-line stone removal device. The investigators therefore conducted a multicenter prospective randomized trial to compare catheter performance in patients with periampullary diverticulum.
A prospective, multi-center, investigator sponsored, randomized controlled trial, 80
subjects will be randomly assigned to groups that were treated with basket or balloon
catheters.
A descriptive analysis will be performed on primary endpoint, containing frequency of number
and percentage of patients. A two proportion equality test will be conducted to explore
whether incidence rates are different.Descriptive statistics including number (N), mean,
median, standard deviation, minimum and maximum, will be produced for all continuous
variables. Frequency tables of number (N) and percentage of subjects will be produced for
all categorical variables.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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