Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05746832 - Failed Retrograde Cholangiopancreatography (ERCP) Stone Extraction: Surgical Interference N/A
Not yet recruiting NCT05823181 - Early Versus Late Laparoscopic Exploration of Common Bile Duct After Failure of Extraction of Common Bile Duct Stones by ERCP
Not yet recruiting NCT06071247 - Application and Translational Research of 3D Printed in Treatment of Choledocholithiasis Under ERCP N/A
Completed NCT02349568 - The Cost Effectiveness of Endoscopic Ultrasound ( EUS ) Based Strategy in Diagnosis of Common Bile Duct Stones N/A
Recruiting NCT04410848 - Symbolic Regression Model To Predict Choledocholithiasis
Completed NCT05068739 - Needle Knife Fistulotomy Versus Partial Ampullary Endoscopic Mucosal Resection for Difficult Biliary Cannulation N/A
Completed NCT02394327 - Endoscopic Nasogallbladder Drainage Versus Gallbladder Stenting Before Cholecystecomy N/A
Not yet recruiting NCT06011941 - Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis N/A
Completed NCT05186350 - SpyGlass Versus ESWL for Large Common Bile Duct Stones N/A
Completed NCT03490383 - Study of Microbiota in Bile From Patients With Common Bile Duct Stone During ERCP
Completed NCT05901363 - ERCP Plus Laparoscopic Cholecystectomy Versus Laparoscopic Common Bile Duct Exploration and Cholecystectomy N/A
Completed NCT03422042 - Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis N/A
Recruiting NCT05945797 - Effects of Dexamethasone on Common Bile Duct Cannulation Time N/A
Active, not recruiting NCT02189421 - Multibending vs Conventional Endoscope for Direct Peroral Cholangioscopy N/A
Recruiting NCT06092905 - Endoscopic Common Bile Duct Stones Clearance During Pregnancy