Risk Factors for Recurrence of Primary Bile Duct Stones

Common Bile Duct Stones Clinical Trial

Official title:

Case-control Study of Risk Factors for Recurrence of Primary Bile Duct Stones

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02144493
• Other study ID #: YJH-1
• Secondary ID: ChuncheonSHH YJH
• Status: Recruiting
• Phase: N/A
• First received: May 12, 2014
• Last updated: May 19, 2014
• Start date: May 2014
• Est. completion date: December 2014

Study information

• Verified date: May 2014
• Source: Chuncheon Sacred Heart Hospital
• Contact: Jai Hoon Yoon, M.D.,Ph.D.
• Phone: +821032553957
• Email: jaihoonyoon[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Calculi
• Common Bile Duct Stones

Intervention

Other:
• The existence of periampullary diverticulum
Periampullary diverticulum has been postulated as risk factor of recurrent CBD stone.
• CBD angle
Narrow CBD angle has been postulated as risk factor for the development of recurrent CBD stone

Locations

Country	Name	City	State
Korea, Republic of	Chuncheon Sacred Heart Hospital	Chuncheon	Gangwon-do

Sponsors (1)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

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. Epub 2006 Jul 20. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The risk factors for the development of recurrent CBD stone	The risk factors for the development of recurrent CBD stone will be assessed by multivariate analysis, based on results of univariate analyses. (statistical method: logistic regression analysis)	retrospective (up to 8 years)	No
Primary	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)	No
Secondary	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)	retrospective (up to 8 years)	No