Clinical trial NCT02144493: Risk Factors for Recurrence of Primary Bile Duct Stones
Official title: Case-control Study of Risk Factors for Recurrence of Primary Bile Duct Stones
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Common Bile Duct Stones
Keywords: common bile duct stones
diverticulum
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2014-05-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_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 .

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The association between existence of periampullary diverticulum and recurrent CBD stone
timeFrame: retrospective (up to 8 years)
Secondary outcomes:
measure: The association between common bile duct angle and existence of recurrent CBD stone
timeFrame: retrospective (up to 8 years)
Other outcomes:
measure: The risk factors for the development of recurrent CBD stone
timeFrame: retrospective (up to 8 years)
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart Hospital
state: Gangwon-do
Study officials:
affiliation: Hallym University College of Medicine, Chuncheon Sacred Heart hospital
name: Jai Hoon Yoon, M.D..Ph.D.
role: STUDY_CHAIR
References:
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. doi: 10.1007/s00464-005-0656-x. Epub 2006 Jul 20.
citation: 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.
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.