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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
Sponsor:
Information provided by (Responsible Party):
Nisa Netinatsunton, Prince of Songkla University

Brief Summary:
For endoscopist, ERCP for bile duct stone removal is the most widely performed procedure. However, the risk associated radiation exposure to patients and staff are not neglible. Earlier studies, ERCP without the use of fluoroscopy has been reported high success for bile duct stone removal in pregnant patients to prevent radiation exposure to the fetus. EUS is highy accurate technique in detecting common bile duct stone and guiding for therapeutic intervention. There has been a few data from literature showed that EUS guided CBD stone ( CBDS ) removal are equivalent to those following ERCP in term of successful CBDS removal and complications. This randomized trial is designed to address the question that EUS guided CBDS removal is equivalent to ERCP in term of efficacy and safety.

Condition or disease Intervention/treatment Phase
Choledocholithiasis Procedure: ERCP without the use of fluoroscopy Procedure: ERCP with the use of fluoroscopy Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Treatment success [ Time Frame: 24 months ]
    The number of patients who achieved complete stone clearance in either EGWF or ERCP techniques.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients who had EUS presence of CBDS ≤ 10 mm, and EUS images absence of CBD stricture and CBD narrowing below the stones

Exclusion Criteria:

  • pregnancy
  • concomitant intrahepatic bile duct stones
  • malignant bile duct stricture
  • altered gastrointestinal anatomy
  • instability hemodynamics
  • concomitant emergency situation
  • unwilling to participate

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): NCT02870686


Locations
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Thailand
NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University
Hatyai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
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Principal Investigator: Nisa Netinatsunton, MD. NKC Institute of Gastroenterology and Hepatology , Faculty of Medicine, Prince of Songkla University.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nisa Netinatsunton, Principal Investigator, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT02870686     History of Changes
Other Study ID Numbers: EC: 56-199-21-3-2
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The individual data of patients participating in the study are not available for public sharing since we did not obtain the consent to share the data of patient

Keywords provided by Nisa Netinatsunton, Prince of Songkla University:
ERCP
EUS guided ERCP without fluoroscopy

Additional relevant MeSH terms:
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Choledocholithiasis
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis