Balloon Catheter vs. Basket Catheter for Endoscopic Bile Duct Stone Extraction
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|ClinicalTrials.gov Identifier: NCT02909595|
Recruitment Status : Completed
First Posted : September 21, 2016
Last Update Posted : December 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Biliary Calculi||Device: Balloon catheter Device: Basket catheter||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|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|
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).
- 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 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.
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
|Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University|
|HeFei, Anhui, China, 230001|
|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|