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

NCT05639816 | Completed

• 1 other identifier: 134/2562
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Bile Duct Calculi

Keywords

endoscopic retrograde cholangiopancreatography; endoscopic ultrasound; cholangitis

Outcome Measures

Primary Outcomes (1)

• prevalence of residual CBD stone

  Detected residual CBD stone by endoscoic ultrasound

  1 day

Secondary Outcomes (2)

• factors associated with retained CBD stone

  1 day

• Complicaion and clinical outcome

  6 months

Study Arms (2)

saline irrigation group

EXPERIMENTAL

The patients received saline irrigation of common bile duct after complete ERCP stone removal confirmed by occluded cholangiogram

Procedure: Saline irrigation group

control

NO INTERVENTION

The patients whom complete ERCP stone removal confirmed by occluded cholangiogram were follow up according to standard treatment

Interventions

Saline irrigation group PROCEDURE

Normal saline irrigation of common bile duct after complete stone removal

saline irrigation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi Hospital

Bangkok, Thailand

Location

Related Publications (2)

• 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.

  PMID: 19249039 RESULT

• 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.

  PMID: 29610513 RESULT

MeSH Terms

Conditions

Gallstones; Cholangitis

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Bile Duct Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients are blinded to the treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Included patients are randomized to two group, study group and control group an followed up parallelly.

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: December 6, 2022
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 6, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)