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Recruiting NCT06215040

The Treatment Effect for Asymptomatic Common Bile Duct Stone

Observational Choledocholithiasis Asymptomatic Condition Quality of Life

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endoscopic retrograde cholangiopancratography.
Who it may be relevant to
Registry conditions: Choledocholithiasis, Asymptomatic Condition, Quality of Life. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Multicenter Prospective Study for Efficacy of Asymptomatic Common Bile Duct Stone Treatment

Overview

This study is prospective, multicenter study for identify the characteristics of asymptomatic common bile duct stones and effectiveness of treatment.

Detailed description

There is no conflcts for treatment of symptomatic common bile duct stone. As more imaging examination such as healthy screening, more asymptomatic common bile duct stone patients are found. Current guideline for aymptomatic common bile duct stone is removal using endoscopic retrograde cholangiopancreatography. However, the previous studies that support this guideline included patients who just underwent cholecystectomy and were diagnosed as common bile duct stone. There is no prospective study for identify the treatment effectiveness of common bile duct stone removal in asymptomatic patients who are dignosed in healthy screening. Therefore, we are going to find the effectiveness of common bile duct stone removal by comparing questionnarie before and after removal of common bile duct stone in asymptomatic and incidentally found common bile duct stone patients. In addition, we are going to follow up patients who do not want to undergo common bile duct stone removal and find the rate of cholangitis risk. We also want to identify extact complication rate for endoscopic retrograde pancreatocholangiographic procedures in asymptomatic common bile duct stone.

Interventions

  • Procedure Endoscopic retrograde cholangiopancratography
    common bile duct stone removal

Primary outcome measures

  • Score of quality of life [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • diagnosed as common bile duct stone by image modality examination
  • agreement for this study enrollment

Exclusion criteria

  • no definite common bile duct stone by image modality examination
  • symptomatic patients who complain with fever/abdominal pain that compatible with common bile duct stone related symptom
  • previously diagnosed as pancreatobiliary malignancy
  • previously treated by endoscopic or percutaneous treatment for bile duct stones
  • severe cardio or pulmonary disease
  • pregnancy or possibility of pregnancy
  • who do not agree with study enrollment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

South Korea · 1 center
  • Kyungpook National University Hospital — Daegu

Identifiers

NCT: NCT06215040 · KNUH2023-09-029-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗