Clinical trial NCT02666820: Endoscopic Papillary Large Balloon Dilatation Versus Mechanical Lithotripsy for Large Stones
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Bile Duct Stones
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Complete stone clearance rate in the index ERCP
timeFrame: 24 hours
Secondary outcomes:
measure: Procedure time
timeFrame: 24 hours
measure: Complete stone clearance rate in the rescue therapy
timeFrame: 24 hours
measure: Complication rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Hatyai
country: Thailand
facility: NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University
state: Songkla
Study officials:
affiliation: NKC Institute of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, Thailand, 90110.
name: Bancha Ovartlarnporn, MD.
role: STUDY_DIRECTOR
References: