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RecruitingNCT06215040Updated Jan 22, 2024

The Treatment Effect for Asymptomatic Common Bile Duct Stone

An observational study in Choledocholithiasis, Asymptomatic Condition and Quality of Life, sponsored by Kyungpook National University Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-22.

Sponsored by Kyungpook National University Hospital · Observational

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 10 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Choledocholithiasis
  • Asymptomatic Condition
  • Quality of Life
03

In context

Choledocholithiasis

109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.

This study's planned enrollment of 120 is below the median of 200 across 31 observational studies indexed under Choledocholithiasis.

Browse Choledocholithiasis studies →

Lead sponsor

Kyungpook National University Hospital is the lead sponsor of 80 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Healthy volunteers who have common bile duct stones without cholangitis symptom

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • Asymptomatic common bile duct stone

    Procedure: Endoscopic retrograde cholangiopancratography

Interventions

  • ProcedureEndoscopic retrograde cholangiopancratography

    common bile duct stone removal

    Also known as: observation

06

What researchers measure

Primary outcomes

  1. Score of quality of life

    Compare the quality of life before and after treatment

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2024 (actual). Primary completion is estimated for Dec 2027, 47 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 10, 2024
First posted
Jan 22, 2024
StartActual
Jan 2, 2024
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2028
Last update
Jan 22, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06215040
Lead sponsor
Kyungpook National University Hospital
Collaborators
Yeungnam University Hospital, Keimyung University Dongsan Medical Center, Daegu Catholic University Medical Center, Kyungpook National University Chilgok Hospital, Daegu Fatima Hospital
Responsible party
Jun Heo (Assistant Professor, Kyungpook National University Hospital) — Principal investigator
First posted
Jan 22, 2024
Start date
Jan 2, 2024
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jan 22, 2024

Study contacts

Jun Heo
Contact
hero797@hanmail.net
82532005505

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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