NCT02909595

Balloon Catheter vs. Basket Catheter for Endoscopic Bile Duct Stone Extraction

Balloon Catheter Versus Basket Catheter for Endoscopic Bile Duct Stone Extraction in Patients With Periampullary Diverticulum:a Multicenter Randomized Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Biliary Calculi

Interventions

Type	Name	Description
DEVICE	Balloon catheter	Balloon stone extraction was carried out with a balloon catheter \[Extractor Pro RX \[M00547000, M00547010, or M00547020\]; Boston Scientific,Shang hai,China). The Extractor Pro has multiple sizes (9-12, 12-15, and 15-18mm), the choice being made on the basis of the CBD diameter. It has a contrast-injection hole above the balloon for the performance of balloon occlusion cholangiography (BOC).
DEVICE	Basket catheter	Basket stone extraction was performed with a basket catheter (Flower Basket V \[FG-V435P or FG-V425PR\]; Olympus Corp., Shang hai,China).

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-09-21
• Last updated: 2016-12-14

Locations

1 site across 1 country: China