Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03683485
Other study ID # 2018-03-009
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date August 1, 2021

Study information

Verified date September 2018
Source Dankook University
Contact Jun Ho Choi, MD, PhD
Phone 82-41-550-7631
Email mdcjh78@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

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

Sponsors (4)

Lead Sponsor Collaborator
Dankook University Inje University, The Catholic University of Korea, Wonkwang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT05035433 - Effect of the Sequence of Dilatation and Lithotripsy on the Treatment of Choledocholithiasis With ERCP N/A
Completed NCT02985164 - Radiation Exposure During Endoscopic Retrograde Cholangiopancreatography Phase 3
Completed NCT05533944 - Fast-tracking ERCP Learning: Does Training on a Mechanical Simulator Improve Trainee's Clinical Performance? N/A
Suspended NCT04559867 - Fistulotomy as the Primary Cannulation Technique for All Patients Undergoing ERCP: A Randomized, Controlled Trial N/A
Active, not recruiting NCT05592795 - Explore the Effects and Mechanisms of ERCP and EST on Biliary Microecology
Enrolling by invitation NCT04719117 - Retrograde Cholangiopancreatography AI Assisted System Validation on Effectiveness and Safety
Enrolling by invitation NCT04572711 - Prospective Evaluation of Biliary Tissue Sampling With ERCP
Completed NCT03263481 - Intraductal Secretin Stimulation Test: What Is the Proper Collection Time? N/A
Completed NCT03292627 - Non-invasive Monitor in Endoscopic Invasive Procedure
Recruiting NCT06265311 - IDUS in CBD Stone Recurrence High Risk Patients N/A
Completed NCT06031363 - The Optimal Dose of Indomethacin Suppository for Preventing Post-ERCP Pancreatitis N/A
Recruiting NCT05261997 - Endotherapy for Painless Chronic Pancreatitis N/A
Completed NCT02698137 - Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP)
Recruiting NCT04910087 - The Effect of Anesthesia Management on Optic Nerve Sheath Diameter in the Ercp Procedures N/A
Recruiting NCT05246657 - EUS-guided Entero-biliary Anastomosis for Therapeutic Access in Benign Biliary Obstructions
Recruiting NCT05303662 - Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an ERCP in Four Different Countries
Terminated NCT05129449 - A Clinical Study With the Medical Device PowerSpiral for Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
Completed NCT03561441 - Tailored Hydration for the Prevention of Post-ERCP Pancreatitis N/A
Not yet recruiting NCT06196164 - A RCT of Low MBO Drainage Strategies N/A
Terminated NCT01792466 - RCT of the Double Wire Technique for Sphincterotomy N/A