Long-duration EPBD vs EST for Removal of Biliary Stones
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
1 other identifier
interventional
358
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2018
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2018
CompletedFirst Submitted
Initial submission to the registry
April 5, 2018
CompletedFirst Posted
Study publicly available on registry
September 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedOctober 1, 2018
September 1, 2018
1.1 years
April 5, 2018
September 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of adverse event
Number of participants with treatment-related adverse events
up to 1 month after ERCP
Secondary Outcomes (6)
the stone clearance rate at the index ERCP
during ERCP
direct cost
within 30 day after ERCP
recurrence of choledocholithiasis
more than 3 year follow-up
adverse event (pancreatitis)
up to 1 month after ERCP
adverse event (bleeding)
up to 1 month after ERCP
- +1 more secondary outcomes
Study Arms (2)
long duration EPBD group
EXPERIMENTALBalloon 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.
endoscopic sphincterotomy (EST) group
ACTIVE COMPARATORAfter 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dankook Universitylead
- Inje Universitycollaborator
- The Catholic University of Koreacollaborator
- Wonkwang Universitycollaborator
Study Sites (4)
Dankook University College of Medicine
Cheonan, Chungcheongnam-do, 330-715, South Korea
Wonkwang University
Iksan, Jeollabukdo, South Korea
Inje University, Haeundae Paik Hospital
Busan, South Korea
St. Mary's Hospital, The Catholic University of Korea,
Daejeon, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Ho Choi, MD, PhD
Dankook University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 5, 2018
First Posted
September 25, 2018
Study Start
April 1, 2018
Primary Completion
May 1, 2019
Study Completion
August 1, 2021
Last Updated
October 1, 2018
Record last verified: 2018-09