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NCT Number: NCT06215040

The Treatment Effect for Asymptomatic Common Bile Duct Stone

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

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kyungpook National University Hospital

Daegu, Gyungsangbok-do, South Korea

Location status: Recruiting

Location contact

Jun Heo

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Endoscopic retrograde cholangiopancratography

Procedure

common bile duct stone removal

Other names: observation

Primary outcomes

  1. Score of quality of life

    Time frame: 3 months

    Compare the quality of life before and after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jan 22, 2024
Registry last updated
Jan 22, 2024

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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