Clinical trial NCT03683485: Long-duration EPBD vs EST for Removal of Biliary Stones
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholangiopancreatography, Endoscopic Retrograde
Keywords: Cholangiopancreatography, Endoscopic Retrograde
Lead sponsor: Dankook University
Sponsor class: OTHER
Collaborators: name: Inje University
name: The Catholic University of Korea
name: Wonkwang University
First posted: 2018-09-25
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: rate of adverse event
timeFrame: up to 1 month after ERCP
Secondary outcomes:
measure: the stone clearance rate at the index ERCP
timeFrame: during ERCP
measure: direct cost
timeFrame: within 30 day after ERCP
measure: recurrence of choledocholithiasis
timeFrame: more than 3 year follow-up
measure: adverse event (pancreatitis)
timeFrame: up to 1 month after ERCP
measure: adverse event (bleeding)
timeFrame: up to 1 month after ERCP
measure: adverse event (cholangitis)
timeFrame: up to 1 month after ERCP
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Dankook University College of Medicine
state: Chungcheongnam-do
city: Iksan
country: Korea, Republic of
facility: Wonkwang University
state: Jeollabukdo
city: Busan
country: Korea, Republic of
facility: Inje University, Haeundae Paik Hospital
city: Daejeon
country: Korea, Republic of
facility: St. Mary's Hospital, The Catholic University of Korea,
Study officials:
affiliation: Dankook University
name: Jun Ho Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: