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

NCT02909595 | Completed Phase 4 DMC

• 1 other identifier: Catheter001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Calculi

Outcome Measures

Primary Outcomes (1)

• 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.

  The primary end point was the rate of complete removals of stones within 10 min.

Secondary Outcomes (1)

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

  Secondary endpoints is the rate of adverse events at 24 h after ERCP.

Study Arms (2)

Balloon catheter group

EXPERIMENTAL

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

Device: Balloon catheter

Basket catheter group

ACTIVE COMPARATOR

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

Device: Basket catheter

Interventions

Balloon catheter 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).

Balloon catheter group

Basket catheter DEVICE

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

Basket catheter group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

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

Hefei, Anhui, 230001, China

Location

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2016
• First Posted: September 21, 2016
• Study Start: November 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 14, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)