Endoscopic Papillary Large Balloon Dilatation Versus Mechanical Lithotripsy for Large Stones

Common Bile Duct Stones Clinical Trial

Official title:

Endoscopic Papillary Large Balloon Dilatation Versus Sphincterotomy +/- Mechanical Lithotripsy for Removal of Bile Duct Stones With a Mean Stone > 20 mm : A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02666820
• Other study ID #: 53-170-14-3-2
• Status: Completed
• Phase: N/A
• First received: January 25, 2016
• Last updated: January 28, 2016
• Start date: December 2010
• Est. completion date: May 2014

Study information

• Verified date: January 2016
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Description:

The large common bile duct stones (CBDS) remains a therapeutic challenge in ERCPs. Large CBDS are generally refractory to be removed by EST and stone extraction balloons and or baskets. Traditional rescue therapy was the technique of stone fragmentation using ML. The previous reports have shown that EST with ML was successful in the fragmentation of large stones yielding stone clearance rate from 68 t0 79 %. EST-LBD has been shown favorable outcome in the treatment of large bile duct stone. A meta-analysis comparing the effectiveness and complications between EST-LBD and EST in the management of CBDS showed that EST-LBD was as effective as EST for the removal of large or difficult of CBDS in terms of stone clearance in the first ERCP session of 87.87 % vs. 84.15 % and overall clearance of 97.35 % vs. 96.35 % but EST-LBD was associated with fewer complications as well as reduced need for ML compared to EST. The efficacy of EST-ML versus EST-LBD as a therapy for relatively large CBDS, a mean stone size > 20 mm in currently not well defined. The investigators, herein, compared the efficacy and complications between EST followed by LBD or ML for the removal of CBDS > 15 mm with a mean stone size > 20 mm.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: May 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: -Patients with age>/= 18 years with confirmed or suspected CBDS at our institute were enrolled in the study.

• 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.

Exclusion Criteria:-pregnant woman

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Bile Duct Stones

Intervention

Procedure:
• Large balloon dilatation
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.
• Mechanical lithotripsy
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.

Locations

Country	Name	City	State
Thailand	NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University	Hatyai	Songkla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete stone clearance rate in the index ERCP	The number of patients who was achieved complete stone clearance in the index ERCP	24 hours	Yes
Secondary	Procedure time	The procedure time was the time between insertion of the index device namely, a balloon or ML, and occlusion of cholangiogram	24 hours	No
Secondary	Complete stone clearance rate in the rescue therapy	The number of patients who was achieved complete stone clearance in the rescue therapy	24 hours	Yes
Secondary	Complication rate	The number of patients who developed complications related procedure included pancreatitis, bleeding, perforation, cholangitis as defined and graded according to the consensus guideline and sedation related complications.	30 days	Yes