Long-duration EPBD vs EST for Removal of Biliary Stones

NCT ID: NCT03683485

Last Updated: 2018-10-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 358 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2021-08-01

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.

Conditions

Cholangiopancreatography, Endoscopic Retrograde

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

long duration EPBD group

Balloon dilation was performed using wire-guided hydrostatic balloon catheters. 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. Stones were removed by standard techniques, including balloon or basket catheters.

Group Type: EXPERIMENTAL

long duration EPBD

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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.

endoscopic sphincterotomy (EST) group

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. A complete sphincterotomy was defined by the free passage of a fully bowed sphincterotome and the presence of spontaneous bile drainage. A complete sphincterotomy was defined by the free passage of a fully bowed sphincterotome and the presence of spontaneous bile drainage.

Group Type: ACTIVE_COMPARATOR

long duration EPBD

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inje University

OTHER

Sponsor Role: collaborator

The Catholic University of Korea

OTHER

Sponsor Role: collaborator

Wonkwang University

OTHER

Sponsor Role: collaborator

Dankook University

OTHER

Sponsor Role: lead

Responsible Party

Jun Ho Choi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Ho Choi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dankook University

Locations

Dankook University College of Medicine

Cheonan, Chungcheongnam-do, South Korea

Site Status: RECRUITING

Wonkwang University

Iksan, Jeollabukdo, South Korea

Site Status: RECRUITING

Inje University, Haeundae Paik Hospital

Busan, , South Korea

Site Status: RECRUITING

St. Mary's Hospital, The Catholic University of Korea,

Daejeon, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jun Ho Choi, MD, PhD

Role: CONTACT

mdcjh78@gmail.com

82-41-550-7631

Se Weon Kim, MD

Role: CONTACT

intern41@dkuh.co.kr

82-41-550-7630

Facility Contacts

Jun Ho Choi, MD, PhD

Role: primary

mdcjh78@gmail.com

82-41-550-7631

Se Weon Kim, MD

Role: backup

intern41@dkuh.co.kr

82-41-550-6694

Hyung Ku Chon, MD

Role: primary

menzo@jbnu.ac.kr

82-63-859-2564

Tae Hyeon Kim, MD, PhD

Role: backup

kth@wonkwang.ac.kr

Joon Hyuck Choi, MD

Role: primary

cladius2@naver.com

Won Seok Park, MD

Role: primary

mdonekr@naver.com

Kyu-Hyun Paik, MD

Role: backup

Other Identifiers

2018-03-009

Identifier Type: -

Identifier Source: org_study_id