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

NCT02909595 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-12-14

No results posted yet for this study

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.

Conditions

  • Biliary Calculi

Interventions

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).

Sponsors & Collaborators

  • Anhui Provincial Hospital

    lead OTHER_GOV

Principal Investigators

  • Shao Feng, MD · Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University

  • Wei Qi, MD · No.2 of HeFei Hospital Affiliated Anhui Medical College

  • YongQiang Jiang, MD · Dong fang Hospital Affiliated Anhui University Of Science & Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02909595 on ClinicalTrials.gov