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

NCT ID: NCT02909595

Last Updated: 2016-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-11-30

Brief Summary

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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

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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

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Biliary Calculi

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Balloon catheter group

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

Group Type EXPERIMENTAL

Balloon catheter

Intervention Type DEVICE

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).

Basket catheter group

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

Group Type ACTIVE_COMPARATOR

Basket catheter

Intervention Type DEVICE

Basket stone extraction was performed with a basket catheter (Flower Basket V \[FG-V435P or FG-V425PR\]; Olympus Corp., Shang hai,China).

Interventions

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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).

Intervention Type 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).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anhui Provincial Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shao Feng, MD

Role: PRINCIPAL_INVESTIGATOR

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

Wei Qi, MD

Role: PRINCIPAL_INVESTIGATOR

No.2 of HeFei Hospital Affiliated Anhui Medical College

YongQiang Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Dong fang Hospital Affiliated Anhui University Of Science & Technology

Locations

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

Hefei, Anhui, China

Site Status

Countries

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China

Other Identifiers

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Catheter001

Identifier Type: -

Identifier Source: org_study_id