Long-duration EPBD vs EST for Removal of Biliary Stones

Not Applicable

• Conditions: Cholangiopancreatography, Endoscopic Retrograde

• Registration Number: NCT03683485
• Lead Sponsor: Dankook University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2018-04-05
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-25
• Last Update Submitted: 2018-09-27
• Last Update Posted: 2018-10-01
• Primary Completion: 2019-05-01
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 358

Inclusion Criteria

• Consecutive patients were invited to participate by the investigators or research staff if they were at least 18 years old,
• patients who had known or suspected choledocholithiasis

Exclusion Criteria

• active acute pancreatitis
• septic shock,
• coagulopathy (international normalized ratio >1.2, partial thromboplastic time greater than twice that of control),
• platelet count <50,000 x 103/uL,
• anticoagulation therapy within 48 hours of the procedure,
• stone diameter > 8 mm,
• bile duct diameter >15 mm, prior sphincterotomy,
• need for precut sphincterotomy for biliary access,
• biliary stricture,
• Billroth II or Roux-en-Y anatomy,
• periampullary malignancies,
• primary sclerosing cholangitis, pregnancy,
• and inability to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
rate of adverse event	up to 1 month after ERCP	Number of participants with treatment-related adverse events

Secondary Outcome Measures

Name	Time	Method
adverse event (pancreatitis)	up to 1 month after ERCP	rate of pancreatitis
direct cost	within 30 day after ERCP	The direct cost included the total cost for the entire admission, which comprised costs of hospital stay, performed procedures, and management of complications
recurrence of choledocholithiasis	more than 3 year follow-up	recurrent choledocholithiasis or acute cholangitis either with or without bile duct stones, and overall hepatobiliary complications
the stone clearance rate at the index ERCP	during ERCP	complete extraction of choledocholithiasis of all stones, fragments, and sludge at the initial procedure
adverse event (bleeding)	up to 1 month after ERCP	rate of bleeding
adverse event (cholangitis)	up to 1 month after ERCP	rate of cholangitis

Trial Locations

Locations (4)

Dankook University College of Medicine; 🇰🇷 Cheonan, Chungcheongnam-do, Korea, Republic of

Wonkwang University; 🇰🇷 Iksan, Jeollabukdo, Korea, Republic of

Inje University, Haeundae Paik Hospital; 🇰🇷 Busan, Korea, Republic of

St. Mary's Hospital, The Catholic University of Korea,; 🇰🇷 Daejeon, Korea, Republic of