The Treatment Effect for Asymptomatic Common Bile Duct Stone

January 10, 2024 updated by: Jun Heo, Kyungpook National University Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Healthy volunteers who have common bile duct stones without cholangitis symptom

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Asymptomatic common bile duct stone
Procedure: Endoscopic retrograde cholangiopancratography
common bile duct stone removal
Other Names:
  • observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of quality of life
Time Frame: 3 months
Compare the quality of life before and after treatment
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Hospital

Collaborators

Daegu Catholic University Medical Center
Kyungpook National University Chilgok Hospital
Yeungnam University Hospital
Keimyung University Dongsan Medical Center
Daegu Fatima Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KNUH2023-09-029-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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