Endoscopic Papillary Large Balloon Dilatation Versus Mechanical Lithotripsy for Large Stones

NCT02666820 | Completed DMC

• 1 other identifier: 53-170-14-3-2
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic sphincterotomy (EST) combined with large balloon dilation (LBD) has been increasingly accepted as alternative method for removal of large bile duct stones. However, there were limited studies comparing the efficacy of EST in combined with LBD to EST with mechanical lithotripsy (ML). The purpose of this study to compare the efficacy and safety of combined EST- LBD versus EST-ML in the removal of very large bile duct stones.

Conditions

Common Bile Duct Stones

Outcome Measures

Primary Outcomes (1)

• Complete stone clearance rate in the index ERCP

  The number of patients who was achieved complete stone clearance in the index ERCP

  24 hours

Secondary Outcomes (3)

• Procedure time

  24 hours

• Complete stone clearance rate in the rescue therapy

  24 hours

• Complication rate

  30 days

Study Arms (2)

Large balloon dilatation

ACTIVE COMPARATOR

Patients underwent clearance of common bile duct stones using a papillary large balloon dilatation.

Procedure: Large balloon dilatation

Mechanical lithotripsy

ACTIVE COMPARATOR

Patients underwent clearance of common bile duct stones using a mechanical lithotripsy.

Procedure: Mechanical lithotripsy

Interventions

Large balloon dilatation PROCEDURE

After biliary sphincterotomy was performed with full extension to the full length of transverse fold. A 12, 15, 18 or 20 mm CRE-balloon was passed over guide wire and position across the papilla. The balloon was gradually inflated to the largest size of the bile duct stone and/or the bile duct diameter. When complete stone removal was unsuccessful , crossing over treatment was considered at the discretion of the endoscopists.

Large balloon dilatation

Mechanical lithotripsy PROCEDURE

After biliary sphincterotomy was performed with full extension to the full length of transverse fold. A 3x6 cm Trapezoid Rx retrieval stone basket was used to capture the stone and crushing of stones was done when simple stone extraction failed to remove the stone. The stone fragments were then retrieved with a basket and/ or a retrieval balloon. When complete stone removal was unsuccessful , crossing over treatment was considered at the discretion of the endoscopists.

Mechanical lithotripsy

Eligibility Criteria

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

You may qualify if:

• Informed consent was obtained in every patients prior to the procedure
• Patients were randomized to LBD or ML if they had CBD stone \>/= 15 mm in shortest dimension or stone' size was disproportionate to the lower bile duct segment with a ratio of largest stone dimension/lower bile duct segment diameter \> 50 % identified by a cholangiogram at ERCP.

You may not qualify if:

• uncorrectable coagulopathy (INR \>1.5 ), thrombocytopenia( platelet count \< 50,000)
• concomitant intrahepatic duct stones
• ongoing acute pancreatitis or acute cholecystitis
• surgically altered anatomy (i.e. Billroth II or Roux-en-Y reconstruction)
• concomitant pancreatic or biliary malignancy

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Study Officials

• Bancha Ovartlarnporn, MD.

  NKC Institute of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, Thailand, 90110.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: January 28, 2016
• Study Start: December 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2014
• Last Updated: January 29, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)