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Long-duration EPBD vs EST for Removal of Biliary Stones

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ClinicalTrials.gov Identifier: NCT03683485
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : October 1, 2018
Sponsor:
Collaborators:
Inje University
The Catholic University of Korea
Wonkwang University
Information provided by (Responsible Party):
Jun Ho Choi, Dankook University

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.


Condition or disease Intervention/treatment Phase
Cholangiopancreatography, Endoscopic Retrograde Procedure: long duration EPBD Procedure: EST Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 358 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Gallstones

Arm Intervention/treatment
Experimental: 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.
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.

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.

Active Comparator: 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.
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.

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.




Primary Outcome Measures :
  1. rate of adverse event [ Time Frame: up to 1 month after ERCP ]
    Number of participants with treatment-related adverse events


Secondary Outcome Measures :
  1. the stone clearance rate at the index ERCP [ Time Frame: during ERCP ]
    complete extraction of choledocholithiasis of all stones, fragments, and sludge at the initial procedure

  2. direct cost [ Time Frame: within 30 day after ERCP ]
    The direct cost included the total cost for the entire admission, which comprised costs of hospital stay, performed procedures, and management of complications

  3. recurrence of choledocholithiasis [ Time Frame: more than 3 year follow-up ]
    recurrent choledocholithiasis or acute cholangitis either with or without bile duct stones, and overall hepatobiliary complications

  4. adverse event (pancreatitis) [ Time Frame: up to 1 month after ERCP ]
    rate of pancreatitis

  5. adverse event (bleeding) [ Time Frame: up to 1 month after ERCP ]
    rate of bleeding

  6. adverse event (cholangitis) [ Time Frame: up to 1 month after ERCP ]
    rate of cholangitis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683485


Contacts
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Contact: Jun Ho Choi, MD, PhD 82-41-550-7631 mdcjh78@gmail.com
Contact: Se Weon Kim, MD 82-41-550-7630 intern41@dkuh.co.kr

Locations
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Korea, Republic of
Dankook University College of Medicine Recruiting
Cheonan, Chungcheongnam-do, Korea, Republic of, 330-715
Contact: Jun Ho Choi, MD, PhD    82-41-550-7631    mdcjh78@gmail.com   
Contact: Se Weon Kim, MD    82-41-550-6694    intern41@dkuh.co.kr   
Wonkwang University Recruiting
Iksan, Jeollabukdo, Korea, Republic of
Contact: Hyung Ku Chon, MD    82-63-859-2564    menzo@jbnu.ac.kr   
Contact: Tae Hyeon Kim, MD, PhD       kth@wonkwang.ac.kr   
Inje University, Haeundae Paik Hospital Recruiting
Busan, Korea, Republic of
Contact: Joon Hyuck Choi, MD       cladius2@naver.com   
St. Mary's Hospital, The Catholic University of Korea, Recruiting
Daejeon, Korea, Republic of
Contact: Won Seok Park, MD       mdonekr@naver.com   
Contact: Kyu-Hyun Paik, MD         
Sponsors and Collaborators
Dankook University
Inje University
The Catholic University of Korea
Wonkwang University
Investigators
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Principal Investigator: Jun Ho Choi, MD, PhD Dankook University

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Responsible Party: Jun Ho Choi, Assistant Professor, Dankook University
ClinicalTrials.gov Identifier: NCT03683485     History of Changes
Other Study ID Numbers: 2018-03-009
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jun Ho Choi, Dankook University:
Cholangiopancreatography, Endoscopic Retrograde

Additional relevant MeSH terms:
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Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical