Long-duration EPBD vs EST for Removal of Biliary Stones

Cholangiopancreatography, Endoscopic Retrograde Clinical Trial

Official title:

Long-duration (3 Minutes) Endoscopic Papillary Balloon Dilation Versus Endoscopic Sphincterotomy in Patients With a Naive Major Papilla and Small- to Medium Sized Biliary Stones: Multicenter, Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03683485
• Other study ID #: 2018-03-009
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: August 1, 2021

Study information

• Verified date: September 2018
• Source: Dankook University
• Contact: Jun Ho Choi, MD, PhD
• Phone: 82-41-550-7631
• Email: mdcjh78[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 358
• Est. completion date: August 1, 2021
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangiopancreatography, Endoscopic Retrograde
• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• long duration EPBD
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.
• EST
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.

Locations

Country	Name	City	State
Korea, Republic of	Inje University, Haeundae Paik Hospital	Busan
Korea, Republic of	Dankook University College of Medicine	Cheonan	Chungcheongnam-do
Korea, Republic of	St. Mary's Hospital, The Catholic University of Korea,	Daejeon
Korea, Republic of	Wonkwang University	Iksan	Jeollabukdo

Sponsors (4)

Lead Sponsor	Collaborator
Dankook University	Inje University, The Catholic University of Korea, Wonkwang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of adverse event	Number of participants with treatment-related adverse events	up to 1 month after ERCP
Secondary	the stone clearance rate at the index ERCP	complete extraction of choledocholithiasis of all stones, fragments, and sludge at the initial procedure	during ERCP
Secondary	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	within 30 day after ERCP
Secondary	recurrence of choledocholithiasis	recurrent choledocholithiasis or acute cholangitis either with or without bile duct stones, and overall hepatobiliary complications	more than 3 year follow-up
Secondary	adverse event (pancreatitis)	rate of pancreatitis	up to 1 month after ERCP
Secondary	adverse event (bleeding)	rate of bleeding	up to 1 month after ERCP
Secondary	adverse event (cholangitis)	rate of cholangitis	up to 1 month after ERCP