Common Bile Duct StonesNCT02144493
Risk Factors for Recurrence of Primary Bile Duct Stones
An observational study of Common Bile Duct Stones, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial summary
Recurrent common bile duct stone is one of the risk factors of recurrent cholangitis. However, the exact pathophysiology or mechanism of recurrent cholangitis has not been established. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Bile Duct Stones
- What is being tested?
- The existence of periampullary diverticulum and CBD angle
- How many people
- 2 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were diagnosed as CBD stone or calculous cholangitis will be enrolled. These patients will be divided by patienst with recurrent CBD stone (devlopment of CBD stone after 1 year from the first development of CBD stone) or not .
Who may be able to join
- Patients who were performed ERCP due to CBD stone or calculous cholangitis
Who cannot join
- Patients with biliary stricture, PSC, retained GB stone, or who were lost to follow-up.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 200704
Young Hee Lee, 82332405128, hcslib128@hallym.or.kr
Chang Seok Bang, M.D.
About this study
Official title: Case-control Study of Risk Factors for Recurrence of Primary Bile Duct Stones
Recurrent common bile duct stone is one of the risk factors of recurrent cholangitis. However, the exact pathophysiology or mechanism of recurrent cholangitis has not been established. Periampullary diverticulum and narrow angle of common bile duct have been postulated as risk factors of recurrent common bile duct stone. The aim of this study was to evaluate the association between periampullary dierticulum, angle of common bile duct and recurrent common bile duct stone.
Read the detailed description
Recurrent common bile duct stone is one of the risk factors of recurrent cholangitis. However, the exact pathophysiology or mechanism of recurrent cholangitis has not been established. Periampullary diverticulum and narrow angle of common bile duct have been postulated as risk factors of recurrent common bile duct stone. The aim of this study was to evaluate the association between periampullary dierticulum, angle of common bile duct and recurrent common bile duct stone.
This study is patient-control setting study. Firstly, from July 2007 through February 2014, all the patients who were performed ERCP will be enrolled. The inclusion criteria is the patients with common bile duct stone. The exclusion criteria is patients with biliary stenosis, PSC, retained GB stone, or who were lost to follow-up. The main outcome is the association between periampullary diverticulum, common bile duct angle, and recurrent CBD stone. This will be evaluated by univariate and multivariate analyses.
- Conditions
- Common Bile Duct Stones
- Being tested
- The existence of periampullary diverticulum, CBD angle
- Keywords
- common bile duct stones, diverticulum
- Medical subject headings
- Diverticulum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The existence of periampullary diverticulumOther
Periampullary diverticulum has been postulated as risk factor of recurrent CBD stone.
CBD angleOther
Narrow CBD angle has been postulated as risk factor for the development of recurrent CBD stone
| Study group | Role | What they receive |
|---|---|---|
| Patients with recurrent CBD stone | Not described Receives: Other: The existence of periampullary diverticulum; Other: CBD angle | |
| Patients without recurrent CBD stone | Not described Receives: Other: The existence of periampullary diverticulum; Other: CBD angle |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between existence of periampullary diverticulum and recurrent CBD stone
The association between existence of periampullary diverticulum and recurrent CBD stone will be assessed by univariate analysis.(unit of analysis: odds ratio, statistical method: Fisher's exact test)
Measured: retrospective (up to 8 years)
Secondary outcomes (1)
The association between common bile duct angle and existence of recurrent CBD stone
The association between common bile duct angle and recurrent CBD stone will be assessed by univariate analysis (unit of analysis: angle, statistical method: student's t test)
Measured: retrospective (up to 8 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Common Bile Duct StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jai Hoon Yoon, Chuncheon Sacred Heart Hospital
- Investigators
- Jai Hoon Yoon, M.D..Ph.D., Study chair, Hallym University College of Medicine, Chuncheon Sacred Heart hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144493
- Sponsor's protocol ID
- YJH-1
- Other IDs
- ChuncheonSHH YJH-1
- Status last verified
- May 2014
- First submitted
- 12 May 2014
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Keizman D, Shalom MI, Konikoff FM. An angulated common bile duct predisposes to recurrent symptomatic bile duct stones after endoscopic stone extraction. Surg Endosc. 2006 Oct;20(10):1594-9. doi: 10.1007/s00464-005-0656-x. Epub 2006 Jul 20.
PubMed 16858527Katsinelos P, Chatzimavroudis G, Tziomalos K, Zavos C, Beltsis A, Lazaraki G, Terzoudis S, Kountouras J. Impact of periampullary diverticula on the outcome and fluoroscopy time in endoscopic retrograde cholangiopancreatography. Hepatobiliary Pancreat Dis Int. 2013 Aug;12(4):408-14. doi: 10.1016/s1499-3872(13)60063-6.
PubMed 23924499Panteris V, Vezakis A, Filippou G, Filippou D, Karamanolis D, Rizos S. Influence of juxtapapillary diverticula on the success or difficulty of cannulation and complication rate. Gastrointest Endosc. 2008 Nov;68(5):903-10. doi: 10.1016/j.gie.2008.03.1092. Epub 2008 Jul 16.
PubMed 18635174
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case-control Study of Risk Factors for Recurrence of Primary Bile Duct Stones
- ClinicalTrials.gov ID
- NCT02144493
- Acronym / sponsor ID
- YJH-1
- Conditions
- Common Bile Duct Stones
- Keywords
- common bile duct stones, diverticulum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 22 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recurrent common bile duct stone is one of the risk factors of recurrent cholangitis. However, the exact pathophysiology or mechanism of recurrent cholangitis has not been established. Periampullary diverticulum and narrow angle of common bile duct have been postulated as risk factors of recurrent common bile duct stone. The aim of this study was to evaluate the association between periampullary dierticulum, angle of common bile duct and recurrent common bile duct stone.
Detailed description
Recurrent common bile duct stone is one of the risk factors of recurrent cholangitis. However, the exact pathophysiology or mechanism of recurrent cholangitis has not been established. Periampullary diverticulum and narrow angle of common bile duct have been postulated as risk factors of recurrent common bile duct stone. The aim of this study was to evaluate the association between periampullary dierticulum, angle of common bile duct and recurrent common bile duct stone.
This study is patient-control setting study. Firstly, from July 2007 through February 2014, all the patients who were performed ERCP will be enrolled. The inclusion criteria is the patients with common bile duct stone. The exclusion criteria is patients with biliary stenosis, PSC, retained GB stone, or who were lost to follow-up. The main outcome is the association between periampullary diverticulum, common bile duct angle, and recurrent CBD stone. This will be evaluated by univariate and multivariate analyses.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with recurrent CBD stone | – | Other: The existence of periampullary diverticulum, Other: CBD angle |
| Patients without recurrent CBD stone | – | Other: The existence of periampullary diverticulum, Other: CBD angle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were diagnosed as CBD stone or calculous cholangitis will be enrolled. These patients will be divided by patienst with recurrent CBD stone (devlopment of CBD stone after 1 year from the first development of CBD stone) or not .
Key inclusion criteria (1 listed)
- Patients who were performed ERCP due to CBD stone or calculous cholangitis
Key exclusion criteria (1 listed)
- Patients with biliary stricture, PSC, retained GB stone, or who were lost to follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The existence of periampullary diverticulumPeriampullary diverticulum has been postulated as risk factor of recurrent CBD stone. | Other | Patients with recurrent CBD stone, Patients without recurrent CBD stone |
| CBD angleNarrow CBD angle has been postulated as risk factor for the development of recurrent CBD stone | Other | Patients with recurrent CBD stone, Patients without recurrent CBD stone |
Primary outcome
The association between existence of periampullary diverticulum and recurrent CBD stone
Time frame: retrospective (up to 8 years)
The association between existence of periampullary diverticulum and recurrent CBD stone will be assessed by univariate analysis.(unit of analysis: odds ratio, statistical method: Fisher's exact test)
1 secondary outcome
The association between common bile duct angle and existence of recurrent CBD stone
Time frame: retrospective (up to 8 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
- Background: PubMed 16858527Keizman D, Shalom MI, Konikoff FM. An angulated common bile duct predisposes to recurrent symptomatic bile duct stones after endoscopic stone extraction. Surg Endosc. 2006 Oct;20(10):1594-9. doi: 10.1007/s00464-005-0656-x. Epub 2006 Jul 20.
- Background: PubMed 23924499Katsinelos P, Chatzimavroudis G, Tziomalos K, Zavos C, Beltsis A, Lazaraki G, Terzoudis S, Kountouras J. Impact of periampullary diverticula on the outcome and fluoroscopy time in endoscopic retrograde cholangiopancreatography. Hepatobiliary Pancreat Dis Int. 2013 Aug;12(4):408-14. doi: 10.1016/s1499-3872(13)60063-6.
- Background: PubMed 18635174Panteris V, Vezakis A, Filippou G, Filippou D, Karamanolis D, Rizos S. Influence of juxtapapillary diverticula on the success or difficulty of cannulation and complication rate. Gastrointest Endosc. 2008 Nov;68(5):903-10. doi: 10.1016/j.gie.2008.03.1092. Epub 2008 Jul 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jai Hoon Yoon, M.D..Ph.D. study chair
Hallym University College of Medicine, Chuncheon Sacred Heart hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Common Bile Duct Stones, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jai Hoon Yoon, M.D.,Ph.D. (+821032553957, jaihoonyoon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The association between existence of periampullary diverticulum and recurrent CBD stone (time frame: retrospective (up to 8 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02144493, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2014.