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Completed

NCT Number: NCT05639816

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rajavithi Hospital

Bangkok, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline irrigation group

Procedure

Normal saline irrigation of common bile duct after complete stone removal

Primary outcomes

  1. prevalence of residual CBD stone

    Time frame: 1 day

    Detected residual CBD stone by endoscoic ultrasound

Secondary outcomes

  1. factors associated with retained CBD stone

    Time frame: 1 day

    procedural and non-procedural factors related to retained CBD stone

  2. Complicaion and clinical outcome

    Time frame: 6 months

    Complication associated with the procedure, hospital stay, and clinical outcome after the procedure

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 6, 2022
Registry last updated
Dec 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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