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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05639816
Enrollment
70
Registered
2022-12-06
Start date
2021-01-01
Completion date
2021-12-31
Last updated
2022-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common Bile Duct Calculi

Keywords

endoscopic retrograde cholangiopancreatography, endoscopic ultrasound, cholangitis

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.

Interventions

PROCEDURESaline irrigation group

Normal saline irrigation of common bile duct after complete stone removal

Sponsors

Department of Medical Services Ministry of Public Health of Thailand
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

The patients are blinded to the treatment

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
prevalence of residual CBD stone1 dayDetected residual CBD stone by endoscoic ultrasound

Secondary

MeasureTime frameDescription
Complicaion and clinical outcome6 monthsComplication associated with the procedure, hospital stay, and clinical outcome after the procedure
factors associated with retained CBD stone1 dayprocedural and non-procedural factors related to retained CBD stone

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026