Back to resultsEffect of Common Bile Duct Stone Clearance Using Saline Irrigation After Stone Removal: A Prospective Randomized Control Trial.
Primary Purpose
Common Bile Duct Calculi
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Saline irrigation group
Sponsored by
About this trial
This is an interventional treatment trial for Common Bile Duct Calculi focused on measuring endoscopic retrograde cholangiopancreatography, endoscopic ultrasound, cholangitis
Eligibility 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
Sites / Locations
- Rajavithi Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
saline irrigation group
control
Arm Description
The patients received saline irrigation of common bile duct after complete ERCP stone removal confirmed by occluded cholangiogram
The patients whom complete ERCP stone removal confirmed by occluded cholangiogram were follow up according to standard treatment
Outcomes
Primary Outcome Measures
prevalence of residual CBD stone
Detected residual CBD stone by endoscoic ultrasound
Secondary Outcome Measures
factors associated with retained CBD stone
procedural and non-procedural factors related to retained CBD stone
Complicaion and clinical outcome
Complication associated with the procedure, hospital stay, and clinical outcome after the procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05639816
Brief Title
Effect of Common Bile Duct Stone Clearance Using Saline Irrigation After Stone Removal: A Prospective Randomized Control Trial.
Official Title
Effect of Common Bile Duct Stone Clearance Using Saline Irrigation After Stone Removal: A Prospective Randomized Control Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Bile Duct Calculi
Keywords
endoscopic retrograde cholangiopancreatography, endoscopic ultrasound, cholangitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Included patients are randomized to two group, study group and control group an followed up parallelly.
Masking
Participant
Masking Description
The patients are blinded to the treatment
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
saline irrigation group
Arm Type
Experimental
Arm Description
The patients received saline irrigation of common bile duct after complete ERCP stone removal confirmed by occluded cholangiogram
Arm Title
control
Arm Type
No Intervention
Arm Description
The patients whom complete ERCP stone removal confirmed by occluded cholangiogram were follow up according to standard treatment
Intervention Type
Procedure
Intervention Name(s)
Saline irrigation group
Intervention Description
Normal saline irrigation of common bile duct after complete stone removal
Primary Outcome Measure Information:
Title
prevalence of residual CBD stone
Description
Detected residual CBD stone by endoscoic ultrasound
Time Frame
1 day
Secondary Outcome Measure Information:
Title
factors associated with retained CBD stone
Description
procedural and non-procedural factors related to retained CBD stone
Time Frame
1 day
Title
Complicaion and clinical outcome
Description
Complication associated with the procedure, hospital stay, and clinical outcome after the procedure
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Rajavithi Hospital
City
Bangkok
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19249039
Citation
Ang TL, Teo EK, Fock KM, Lyn Tan JY. Are there roles for intraductal US and saline solution irrigation in ensuring complete clearance of common bile duct stones? Gastrointest Endosc. 2009 Jun;69(7):1276-81. doi: 10.1016/j.gie.2008.10.018. Epub 2009 Feb 26.
Results Reference
result
PubMed Identifier
29610513
Citation
Ahn DW, Lee SH, Paik WH, Song BJ, Park JM, Kim J, Jeong JB, Hwang JH, Ryu JK, Kim YT. Effects of Saline Irrigation of the Bile Duct to Reduce the Rate of Residual Common Bile Duct Stones: A Multicenter, Prospective, Randomized Study. Am J Gastroenterol. 2018 Apr;113(4):548-555. doi: 10.1038/ajg.2018.21. Epub 2018 Mar 27.
Results Reference
result
Learn more about this trial
Effect of Common Bile Duct Stone Clearance Using Saline Irrigation After Stone Removal: A Prospective Randomized Control Trial.
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