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Long-duration EPBD vs EST for Removal of Biliary Stones

Primary Purpose

Cholangiopancreatography, Endoscopic Retrograde

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
long duration EPBD
EST
Sponsored by
Dankook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangiopancreatography, Endoscopic Retrograde focused on measuring Cholangiopancreatography, Endoscopic Retrograde

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dankook University College of MedicineRecruiting
  • Wonkwang UniversityRecruiting
  • Inje University, Haeundae Paik HospitalRecruiting
  • St. Mary's Hospital, The Catholic University of Korea,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

long duration EPBD group

endoscopic sphincterotomy (EST) group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

rate of adverse event
Number of participants with treatment-related adverse events

Secondary Outcome Measures

the stone clearance rate at the index ERCP
complete extraction of choledocholithiasis of all stones, fragments, and sludge at the initial procedure
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
recurrence of choledocholithiasis
recurrent choledocholithiasis or acute cholangitis either with or without bile duct stones, and overall hepatobiliary complications
adverse event (pancreatitis)
rate of pancreatitis
adverse event (bleeding)
rate of bleeding
adverse event (cholangitis)
rate of cholangitis

Full Information

First Posted
April 5, 2018
Last Updated
September 27, 2018
Sponsor
Dankook University
Collaborators
Inje University, The Catholic University of Korea, Wonkwang University
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1. Study Identification

Unique Protocol Identification Number
NCT03683485
Brief Title
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Anticipated)
Study Completion Date
August 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dankook University
Collaborators
Inje University, The Catholic University of Korea, Wonkwang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiopancreatography, Endoscopic Retrograde
Keywords
Cholangiopancreatography, Endoscopic Retrograde

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
358 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
long duration EPBD group
Arm Type
Experimental
Arm Description
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.
Arm Title
endoscopic sphincterotomy (EST) group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
long duration EPBD
Intervention Description
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
Intervention Name(s)
EST
Intervention Description
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 Measure Information:
Title
rate of adverse event
Description
Number of participants with treatment-related adverse events
Time Frame
up to 1 month after ERCP
Secondary Outcome Measure Information:
Title
the stone clearance rate at the index ERCP
Description
complete extraction of choledocholithiasis of all stones, fragments, and sludge at the initial procedure
Time Frame
during ERCP
Title
direct cost
Description
The direct cost included the total cost for the entire admission, which comprised costs of hospital stay, performed procedures, and management of complications
Time Frame
within 30 day after ERCP
Title
recurrence of choledocholithiasis
Description
recurrent choledocholithiasis or acute cholangitis either with or without bile duct stones, and overall hepatobiliary complications
Time Frame
more than 3 year follow-up
Title
adverse event (pancreatitis)
Description
rate of pancreatitis
Time Frame
up to 1 month after ERCP
Title
adverse event (bleeding)
Description
rate of bleeding
Time Frame
up to 1 month after ERCP
Title
adverse event (cholangitis)
Description
rate of cholangitis
Time Frame
up to 1 month after ERCP

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Ho Choi, MD, PhD
Phone
82-41-550-7631
Email
mdcjh78@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Se Weon Kim, MD
Phone
82-41-550-7630
Email
intern41@dkuh.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Ho Choi, MD, PhD
Organizational Affiliation
Dankook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dankook University College of Medicine
City
Cheonan
State/Province
Chungcheongnam-do
ZIP/Postal Code
330-715
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Ho Choi, MD, PhD
Phone
82-41-550-7631
Email
mdcjh78@gmail.com
First Name & Middle Initial & Last Name & Degree
Se Weon Kim, MD
Phone
82-41-550-6694
Email
intern41@dkuh.co.kr
Facility Name
Wonkwang University
City
Iksan
State/Province
Jeollabukdo
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyung Ku Chon, MD
Phone
82-63-859-2564
Email
menzo@jbnu.ac.kr
First Name & Middle Initial & Last Name & Degree
Tae Hyeon Kim, MD, PhD
Email
kth@wonkwang.ac.kr
Facility Name
Inje University, Haeundae Paik Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joon Hyuck Choi, MD
Email
cladius2@naver.com
Facility Name
St. Mary's Hospital, The Catholic University of Korea,
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won Seok Park, MD
Email
mdonekr@naver.com
First Name & Middle Initial & Last Name & Degree
Kyu-Hyun Paik, MD

12. IPD Sharing Statement

Learn more about this trial

Long-duration EPBD vs EST for Removal of Biliary Stones

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