Clinical trial NCT02909595: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Biliary Calculi
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2016-09-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The primary endpoint is the rate of complete clearance of the duct in two groups.
timeFrame: The primary end point was the rate of complete removals of stones within 10 min.
Secondary outcomes:
measure: Secondary endpoints is the rate of adverse events such as perforation, pancreatitis,cholangitis,hyperamylasemia and bleeding.
timeFrame: Secondary endpoints is the rate of adverse events at 24 h after ERCP.
Other outcomes:
Locations:
city: HeFei
country: China
facility: Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
state: Anhui
Study officials:
affiliation: Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
name: Shao Feng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: No.2 of HeFei Hospital Affiliated Anhui Medical College
name: Wei Qi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dong fang Hospital Affiliated Anhui University Of Science & Technology
name: YongQiang Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References: