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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02909595
Recruitment Status : Completed
First Posted : September 21, 2016
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
Anhui Provincial Hospital

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.

Condition or disease Intervention/treatment Phase
Biliary Calculi Device: Balloon catheter Device: Basket catheter Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Balloon Catheter Versus Basket Catheter for Endoscopic Bile Duct Stone Extraction in Patients With Periampullary Diverticulum:a Multicenter Randomized Trial
Study Start Date : November 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02909595


Locations
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China, Anhui
Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
HeFei, Anhui, China, 230001
Sponsors and Collaborators
Anhui Provincial Hospital
Investigators
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Principal Investigator: Shao Feng, MD Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
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

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Responsible Party: Anhui Provincial Hospital
ClinicalTrials.gov Identifier: NCT02909595     History of Changes
Other Study ID Numbers: Catheter001
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Gallstones
Calculi
Pathological Conditions, Anatomical
Cholelithiasis
Biliary Tract Diseases
Digestive System Diseases
Cholecystolithiasis
Gallbladder Diseases