EUS Guided ERCP in Bile Duct Stone Removal
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|ClinicalTrials.gov Identifier: NCT02870686|
Recruitment Status : Completed
First Posted : August 17, 2016
Last Update Posted : December 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Choledocholithiasis||Procedure: ERCP without the use of fluoroscopy Procedure: ERCP with the use of fluoroscopy||Not Applicable|
Common bile duct stones (CBDS) can be complicated with various conditions including biliary pain, acute cholangitis, acute pancreatitis and secondary biliary cirrhosis. CBDS should therefore be removed even if patients are asymptomatic.
Endoscopic retrograde cholangiopancreatography (ERCP) is the cornerstone treatment of CBDS. ERCP is often performed under fluoroscopic guidance. This comprises biliary cannulation whereby the bile duct is achieved with a standard ERCP catheter under fluoroscopy guidance, radiocontrast was injected for confirmation and images of biliary system, location and number of CBDS, biliary sphincterotomy was then performed followed by stone extraction using a standard accessories such as a basket and or balloon. Therefore, the endoscopist, endoscopic staff and patient are potentially exposed to ionizing radiation during ERCP. Endoscopists should always attempt to minimize radiation exposure to the personnel staffs and patients by following the ALARA principle ("As Low As Reasonably Achievable"). ERCP without the use of fluoroscopy is the one method to avoid exposure to radiation. A few retrospective case series have been shown that ERCP can be performed with high success rate without the need for fluoroscopic imaging.
EUS has been proven to have diagnostic accuracy comparable to ERCP in the diagnosis of CBDS, and it's associated with a very low procedure related complications and non-radiation exposure procedure. With EUS performed before ERCP, unnecessary ERCP and its related complications can be avoided in patients without CBDS. In patients with CBDS, the images of pancreaticobiliary tract derived from EUS provide an information regarding the location, size and number of CBDS for guiding therapeutic endoscopy, and allowing a therapeutic ERCP in the same session of sedation. Vohra et al. reported the retrospective case series of EUS - based ERCP in 10 pregnant patients, they have shown that EUS performed prior ERCP can eliminate unnecessary ERCP and achieve in CBDS clearance without the use of fluoroscopy. We have previously reported the use of EUS guided ERCP in the removal of CBDS without fluoroscopy (EGWF) in the pilot study, it showed that EGWF was feasible in selected patients with CBDS. The efficacy of EUS guided ERCP in CBDS removal without fluoroscopy compared with standard ERCP has not been fully assessed. We therefore prospectively investigated the efficacy and safety of EGWF versus ERCP in CBDS removal in a larger patient cohort.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Trial Comparing EUS Guided ERCP Without Fluoroscopy With Standard ERCP in Common Bile Duct Stone Removal|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||October 2016|
Active Comparator: ERCP without the use of fluoroscopy
Patients with uncomplicated bile duct stones detected by EUS was assigned to the EUS guided ERCP without fluoroscopy clear all of the bile duct stones.
Procedure: ERCP without the use of fluoroscopy
ERCP removal of stone technique without the use of fluoroscopy involves: (1) catheter with wire achieve bile duct, (2) confirmation of bile duct achievement with catheter aspiration of bile, (3) performance of endoscopic biliary sphinctertome, (4) stone removal with balloon or basket- number of stones removed should compare number detected on EUS, (5) confirmation of complete stone clearance with radiocontrast.
Active Comparator: ERCP with the use of fluoroscopy
Patients with uncomplicated bile duct stones detected by EUS was assigned to underwent ERCP with the use of fluoroscopy to clear all of the bile duct stones.
Procedure: ERCP with the use of fluoroscopy
ERCP removal of stone technique with the use of fluoroscopy involves: (1) catheter with wire achieve bile duct, (2) confirmation of bile duct achievement with fluoroscopy images, (3) performance of endoscopic biliary sphinctertome, (4) stone removal with balloon or basket, (5) confirmation of complete stone clearance with radiocontrast.
- Treatment success [ Time Frame: 24 months ]The number of patients who achieved complete stone clearance in either EGWF or ERCP techniques.
- Technical success [ Time Frame: 24 hours ]The number of patient in whom bile duct was accessed with guide wire in either EGWF or ERCP techniques.
- Compare procedure time [ Time Frame: 24 hours ]Compare procedure time defined as the time between insertion of the catheter and the final occlusion cholangiogram in either EGWF or ERCP groups.
- Compare fluoroscopy time [ Time Frame: 24 hours ]Compare fluoroscopy time defined as the total time of using of fluoroscopy in performing procedure in either EGWF or ERCP groups.
- Complication rate [ Time Frame: 30 days ]The number of patients who developed complications related procedure included pancreatitis, bleeding, perforation, cholangitis as defined and graded according to the consensus guideline and sedation related complications in either EGWF or ERCP techniques.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02870686
|NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University|
|Hatyai, Songkhla, Thailand, 90110|
|Principal Investigator:||Nisa Netinatsunton, MD.||NKC Institute of Gastroenterology and Hepatology , Faculty of Medicine, Prince of Songkla University.|