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
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Dankook University | Inje University, The Catholic University of Korea, Wonkwang University |
Korea, Republic of,
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 |
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