NCT06215040

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jan 2024Dec 2028

Study Start

First participant enrolled

January 2, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

4 years

First QC Date

January 10, 2024

Last Update Submit

January 10, 2024

Conditions

CholedocholithiasisAsymptomatic ConditionQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Score of quality of life

    Compare the quality of life before and after treatment

    3 months

Study Arms (1)

Asymptomatic common bile duct stone

Procedure: Endoscopic retrograde cholangiopancratography

Interventions

Endoscopic retrograde cholangiopancratographyPROCEDURE

common bile duct stone removal

Also known as: observation
Asymptomatic common bile duct stone

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy volunteers who have common bile duct stones without cholangitis symptom

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Hospital

Daegu, Gyungsangbok-do, South Korea

RECRUITING

MeSH Terms

Conditions

CholedocholithiasisAsymptomatic Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

Common Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasisDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Jun Heo

CONTACT

82532005505hero797@hanmail.net

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 10, 2024

First Posted

January 22, 2024

Study Start

January 2, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

January 22, 2024

Record last verified: 2024-01

Locations

KR(1)