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

Sponsor
Rajavithi Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05639816
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
12
Actual Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Saline irrigation group
 N/A

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

Study Type:
Interventional
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.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 :
Jan 1, 2021
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

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

Primary Outcome Measures

  1. prevalence of residual CBD stone [1 day]

    Detected residual CBD stone by endoscoic ultrasound

Secondary Outcome Measures

  1. factors associated with retained CBD stone [1 day]

    procedural and non-procedural factors related to retained CBD stone

  2. Complicaion and clinical outcome [6 months]

    Complication associated with the procedure, hospital stay, and clinical outcome after the procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Rajavithi Hospital Bangkok Thailand

Sponsors and Collaborators

  • Rajavithi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rajavithi Hospital
ClinicalTrials.gov Identifier:
NCT05639816
Other Study ID Numbers:
  • 134/2562
First Posted:
Dec 6, 2022
Last Update Posted:
Dec 6, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Gallstones
Calculi

Study Results

No Results Posted as of Dec 6, 2022