NCT02666820|CompletedDMC
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Sponsor study identifier
interventional
85
1 country
1
Study Start
December 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2013
Actual (reported)Study Completion
May 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2010
Date type not reportedThis date has not been verified as actual or estimated.
May 2013
Actual (reported)May 2014
Actual (reported)January 25, 2016
Actual (reported)January 28, 2016
Actual (reported)Complete stone clearance rate in the index ERCP
The number of patients who was achieved complete stone clearance in the index ERCP
24 hours
Procedure time
24 hours
Complete stone clearance rate in the rescue therapy
24 hours
Complication rate
30 days
Patients underwent clearance of common bile duct stones using a papillary large balloon dilatation.
Patients underwent clearance of common bile duct stones using a mechanical lithotripsy.
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.
NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110, Thailand
Bancha Ovartlarnporn, MD.
NKC Institute of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, Thailand, 90110.
85 participants (actual enrollment reported by the registry).
First Submitted
January 25, 2016
First Posted
January 28, 2016
Study Start
December 2010
Date type not reportedThis date has not been verified as actual or estimated.
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.
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Primary Completion
May 2013
Actual (reported)Study Completion
May 2014
Actual (reported)Last Updated
January 29, 2016
Record last verified: 2016-01
The individual data of patients participating in the study are not available for public sharing since we did not obtain the consent to share the data of patient
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Source: ClinicalTrials.gov.
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