Although EPBD has a lower risk of post-ERCP bleeding and long-term complications than EST and is easier to perform in altered/difficult anatomy, EPBD is reserved for patients with bleeding diathesis by current consensus because some studies reported a higher risk of pancreatitis. However, recent meta-analyses indicate that short EPBD duration increases the risk of post-ERCP pancreatitis, and EPBD with adequate duration has a similar pancreatitis risk and a lower overall complication rate compared with EST for choledocholithiasis. Therefore, this study aim to compare long-duration EPBD vs EST in the treatment of extrahepatic biliary stones.
Gallstones occur in 10%-15% of adults in the United States and are the most common and costly digestive disorder. Concomitant bile duct stones occur in up to 15% of persons with symptomatic gallstones. Endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy is the standard treatment for removal choledocholithiasis. The biliary sphincter is permanently ablated by sphincterotomy. Enteric-biliary reflux occurs with bacterial colonization, increased bile lithogenicity, contamination with cytotoxins, and chronic inflammation of the biliary system. Endoscopic papillary balloon dilation (EPBD) has become an option for removal of stones 1 cm or smaller in size. Advantages of EPBD over EST include a decreased risk of post-ERCP bleeding as well as a decreased risk of stone recurrence and cholangitis. Although a short dilation duration (≤1 minute) was previously advocated, a study that performed EPBD for 1 minute observed a 15.4% risk of post-ERCP pancreatitis with 2 cases of mortality. European Society of Gastrointestinal Endoscopy guideline recommends that the duration of EPBD should exceed 2 minutes because long-duration EPBD (\>1 minute) is preferred over short-duration EPBD (≤1 minute) with better outcomes. A meta-analysis of RCTs showed that the duration of EPBD is inversely associated with the risk of PEP. Previous RCTs comparing outcome between EPBD and EST used short EPBD duration between 25 seconds and 1 minute, and there has been no comparison of outcome between EST and long-duration EPBD. The aim of this study was to compare the early and long term outcomes of patients treated with long duration balloon dilation or sphincterotomy for extraction of bile duct stones in a randomized, multicenter fashion involving a broad spectrum of practices.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
358
An 8-mm dilatation balloon was used for EPBD. Balloons were gradually inflated to maximum pressure for 3 minute, and complete inflation was verified by fluoroscopy.
After deep cannulation was achieved, a complete sphincterotomy was performed with a 25-mm pull-type sphincterotome (Clever Cut 3; KD-V411M, Olympus, Tokyo, Japan) and the sphincter was divided up to the transverse duodenal fold.
Dankook University College of Medicine
Cheonan, Chungcheongnam-do, South Korea
RECRUITINGWonkwang University
Iksan, Jeollabukdo, South Korea
RECRUITINGInje University, Haeundae Paik Hospital
Busan, South Korea
RECRUITINGSt. Mary's Hospital, The Catholic University of Korea,
Daejeon, South Korea
RECRUITINGrate of adverse event
Number of participants with treatment-related adverse events
Time frame: up to 1 month after ERCP
the stone clearance rate at the index ERCP
complete extraction of choledocholithiasis of all stones, fragments, and sludge at the initial procedure
Time frame: during ERCP
direct cost
The direct cost included the total cost for the entire admission, which comprised costs of hospital stay, performed procedures, and management of complications
Time frame: within 30 day after ERCP
recurrence of choledocholithiasis
recurrent choledocholithiasis or acute cholangitis either with or without bile duct stones, and overall hepatobiliary complications
Time frame: more than 3 year follow-up
adverse event (pancreatitis)
rate of pancreatitis
Time frame: up to 1 month after ERCP
adverse event (bleeding)
rate of bleeding
Time frame: up to 1 month after ERCP
adverse event (cholangitis)
rate of cholangitis
Time frame: up to 1 month after ERCP
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