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

December 13, 2016 updated by: Anhui Provincial Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • HeFei, Anhui, China, 230001
        • Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males and females, age > 18 years.
  2. BDSs of diameter ≤10mm, which could be extracted using a standard balloon or basket catheter without mechanical lithotripsy, and a common bile duct (CBD) diameter ≤15mm.
  3. Signed inform consent form and agreed to follow-up on time

Exclusion Criteria:

  1. Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent.
  2. Patients involved in other study within 60 days.
  3. biliary stricture
  4. Billroth II or Roux-en-Y anatomy
  5. Acute pancreatitis.
  6. a history of previous ERCP
  7. pregnant or breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Balloon catheter group
Bile duct stones extraction was carried out with a balloon catheter.
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).
Active Comparator: Basket catheter group
Bile duct stones extraction was carried out with a basket catheter.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary endpoint is the rate of complete clearance of the duct in two groups.
Time Frame: The primary end point was the rate of complete removals of stones within 10 min.
It has a contrast-injection hole above the balloon for the performance of balloon occlusion cholangiography (BOC). For balloon stone extraction, clearance was confirmed if no residual stones remained after the final BOC and balloon sweep. For basket stone extraction, duct clearance by the basket catheter was judged to have been completed when no filling defect was found. Complete clearance of the duct by the basket catheter was defined as no filling defect (other than air) on BOC after a balloon sweep.
The primary end point was the rate of complete removals of stones within 10 min.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary endpoints is the rate of adverse events such as perforation, pancreatitis,cholangitis,hyperamylasemia and bleeding.
Time Frame: Secondary endpoints is the rate of adverse events at 24 h after ERCP.
If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours in patients, who also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP(post-ERCP pancreatitis). Hyperamylasemia will be defined as the serum amylase 3 times more than the upper normal values, without clinical symptoms. During the study, any unexpected medical issue will be called adverse event.
Secondary endpoints is the rate of adverse events at 24 h after ERCP.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anhui Provincial Hospital

Investigators

  • Principal Investigator: Wei Qi, MD, No.2 of HeFei Hospital Affiliated Anhui Medical College
  • Principal Investigator: YongQiang Jiang, MD, Dong fang Hospital Affiliated Anhui University Of Science & Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

September 10, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Estimate)

December 14, 2016

Last Update Submitted That Met QC Criteria

December 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Catheter001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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