NCT02144493

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

May 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

7 months

First QC Date

May 12, 2014

Last Update Submit

May 19, 2014

Conditions

Common Bile Duct Stones

Keywords

common bile duct stonesdiverticulum

Outcome Measures

Primary Outcomes (1)

  • 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)

    retrospective (up to 8 years)

Secondary Outcomes (1)

  • The association between common bile duct angle and existence of recurrent CBD stone

    retrospective (up to 8 years)

Other Outcomes (1)

  • The risk factors for the development of recurrent CBD stone

    retrospective (up to 8 years)

Study Arms (2)

Patients with recurrent CBD stone

Other: The existence of periampullary diverticulumOther: CBD angle

Patients without recurrent CBD stone

Other: The existence of periampullary diverticulumOther: CBD angle

Interventions

The existence of periampullary diverticulumOTHER

Periampullary diverticulum has been postulated as risk factor of recurrent CBD stone.

Patients with recurrent CBD stonePatients without recurrent CBD stone
CBD angleOTHER

Narrow CBD angle has been postulated as risk factor for the development of recurrent CBD stone

Patients with recurrent CBD stonePatients without recurrent CBD stone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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 .

You may qualify if:

  • Patients who were performed ERCP due to CBD stone or calculous cholangitis

You may not qualify if:

  • Patients with biliary stricture, PSC, retained GB stone, or who were lost to follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 200704, South Korea

RECRUITING

Related Publications (3)

  • 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.

    PMID: 16858527BACKGROUND

  • Katsinelos 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.

    PMID: 23924499BACKGROUND

  • Panteris 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.

    PMID: 18635174BACKGROUND

MeSH Terms

Conditions

Diverticulum

Condition Hierarchy (Ancestors)

Diverticular DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Jai Hoon Yoon, M.D..Ph.D.

    Hallym University College of Medicine, Chuncheon Sacred Heart hospital

    STUDY CHAIR

Central Study Contacts

Jai Hoon Yoon, M.D.,Ph.D.

CONTACT

+821032553957jaihoonyoon@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Jai Hoon Yoon

Study Record Dates

First Submitted

May 12, 2014

First Posted

May 22, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations

KR(1)