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Effect of Common Bile Duct Stone Clearance Using Saline Irrigation After Stone Removal: A Prospective Randomized Control Trial.

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ClinicalTrials.gov Identifier: NCT05639816
Recruitment Status : Completed
First Posted : December 6, 2022
Last Update Posted : December 6, 2022
Sponsor:
Information provided by (Responsible Party):
Rajavithi Hospital

Study Description
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Brief Summary:
Retained CBD stone after ERCP is a common problem in clinical practice. This study aimed to evaluate the effect of saline irrigation of common bile duct after complete stone removal considered by ERCP in the reduction of residual CBD stone and the effect on clinical outcome.

Condition or disease Intervention/treatment Phase
Common Bile Duct Calculi Procedure: Saline irrigation group Not Applicable

Detailed Description:
This study aimed to evaluate the effect of saline irrigation of common bile duct after complete stone removal considered by ERCP in the reduction of residual CBD stone and the effect on clinical outcome. Patients with CBD stone who received endoscopic stone removal were included after complete stone clearance was seen on occluded cholangiogram. One arm received saline irrigation of CBD at least 50 ml until clear effluent seen and another arm as control. Both group received endoscopic ultrasound to evaluation for residual stone and followed up for complication and outcome.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Included patients are randomized to two group, study group and control group an followed up parallelly.
Masking: Single (Participant)
Masking Description: The patients are blinded to the treatment
Primary Purpose: Treatment
Official Title: Effect of Common Bile Duct Stone Clearance Using Saline Irrigation After Stone Removal: A Prospective Randomized Control Trial.
Actual Study Start Date : January 1, 2021
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: saline irrigation group
The patients received saline irrigation of common bile duct after complete ERCP stone removal confirmed by occluded cholangiogram
 Procedure: Saline irrigation group
Normal saline irrigation of common bile duct after complete stone removal
No Intervention: control
The patients whom complete ERCP stone removal confirmed by occluded cholangiogram were follow up according to standard treatment


Outcome Measures
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Primary Outcome Measures :
  1. prevalence of residual CBD stone [ Time Frame: 1 day ]
    Detected residual CBD stone by endoscoic ultrasound


Secondary Outcome Measures :
  1. factors associated with retained CBD stone [ Time Frame: 1 day ]
    procedural and non-procedural factors related to retained CBD stone

  2. Complicaion and clinical outcome [ Time Frame: 6 months ]
    Complication associated with the procedure, hospital stay, and clinical outcome after the procedure


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with common bile duct stone
  • Complete stone removal by endoscopy as seen in occluded cholangiogram

Exclusion Criteria:

  • unstable vital sign
  • failed complete stone remval
  • assciated biliary malignancy or history of bile duct surgery
  • associated bile duct stricture or choledochal cyst
  • Toxic cholangitis
  • pregnancy or unable to give informed consent
Contacts and Locations
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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): NCT05639816


Locations
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Thailand
Rajavithi Hospital
Bangkok, Thailand
Sponsors and Collaborators
Rajavithi Hospital
More Information
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Publications of Results:

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Responsible Party: Rajavithi Hospital
ClinicalTrials.gov Identifier: NCT05639816    
Other Study ID Numbers: 134/2562
First Posted: December 6, 2022    Key Record Dates
Last Update Posted: December 6, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Rajavithi Hospital:
endoscopic retrograde cholangiopancreatography
endoscopic ultrasound
cholangitis
Additional relevant MeSH terms:
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Gallstones
Calculi
Pathological Conditions, Anatomical
Cholelithiasis
 Biliary Tract Diseases
Digestive System Diseases
Cholecystolithiasis
Gallbladder Diseases