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

Primary Purpose

Biliary Calculi

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Balloon catheter
Basket catheter
Sponsored by
Anhui Provincial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Calculi

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Balloon catheter group

Basket catheter group

Arm Description

Bile duct stones extraction was carried out with a balloon catheter.

Bile duct stones extraction was carried out with a basket catheter.

Outcomes

Primary Outcome Measures

The primary endpoint is the rate of complete clearance of the duct in two groups.
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.

Secondary Outcome Measures

Secondary endpoints is the rate of adverse events such as perforation, pancreatitis,cholangitis,hyperamylasemia and bleeding.
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.

Full Information

First Posted
September 10, 2016
Last Updated
December 13, 2016
Sponsor
Anhui Provincial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02909595
Brief Title
Balloon Catheter vs. Basket Catheter for Endoscopic Bile Duct Stone Extraction
Official Title
Balloon Catheter Versus Basket Catheter for Endoscopic Bile Duct Stone Extraction in Patients With Periampullary Diverticulum:a Multicenter Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anhui Provincial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Calculi

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Balloon catheter group
Arm Type
Experimental
Arm Description
Bile duct stones extraction was carried out with a balloon catheter.
Arm Title
Basket catheter group
Arm Type
Active Comparator
Arm Description
Bile duct stones extraction was carried out with a basket catheter.
Intervention Type
Device
Intervention Name(s)
Balloon catheter
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Basket catheter
Intervention Description
Basket stone extraction was performed with a basket catheter (Flower Basket V [FG-V435P or FG-V425PR]; Olympus Corp., Shang hai,China).
Primary Outcome Measure Information:
Title
The primary endpoint is the rate of complete clearance of the duct in two groups.
Description
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.
Time Frame
The primary end point was the rate of complete removals of stones within 10 min.
Secondary Outcome Measure Information:
Title
Secondary endpoints is the rate of adverse events such as perforation, pancreatitis,cholangitis,hyperamylasemia and bleeding.
Description
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.
Time Frame
Secondary endpoints is the rate of adverse events at 24 h after ERCP.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females, age > 18 years. 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. Signed inform consent form and agreed to follow-up on time Exclusion Criteria: Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent. Patients involved in other study within 60 days. biliary stricture Billroth II or Roux-en-Y anatomy Acute pancreatitis. a history of previous ERCP pregnant or breastfeeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shao Feng, MD
Organizational Affiliation
Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei Qi, MD
Organizational Affiliation
No.2 of HeFei Hospital Affiliated Anhui Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
YongQiang Jiang, MD
Organizational Affiliation
Dong fang Hospital Affiliated Anhui University Of Science & Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
City
HeFei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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