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NCT05639816 Clinical Trial

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

Common Bile Duct Calculi Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05639816
Other study ID # 134/2562
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date December 31, 2021

Study information
Verified date November 2022
Source Rajavithi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Saline irrigation group
Normal saline irrigation of common bile duct after complete stone removal

Locations
Country Name City State
Thailand Rajavithi Hospital Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (2)

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. 2 — View 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 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary prevalence of residual CBD stone Detected residual CBD stone by endoscoic ultrasound 1 day
Secondary factors associated with retained CBD stone procedural and non-procedural factors related to retained CBD stone 1 day
Secondary Complicaion and clinical outcome Complication associated with the procedure, hospital stay, and clinical outcome after the procedure 6 months
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