Risk Factors for Recurrence of Primary Bile Duct Stones

• Conditions: Common Bile Duct Stones
• Interventions: Other: The existence of periampullary diverticulum; Other: CBD angle

• Registration Number: NCT02144493
• Lead Sponsor: Chuncheon Sacred Heart Hospital

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.

Study Timeline

• Status Verified: 2014-05
• Study Start: 2014-05
• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-19
• Last Update Submitted: 2014-05-19
• Study First Posted: 2014-05-22
• Last Update Posted: 2014-05-22
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with recurrent CBD stone	The existence of periampullary diverticulum	-
Patients with recurrent CBD stone	CBD angle	-
Patients without recurrent CBD stone	The existence of periampullary diverticulum	-
Patients without recurrent CBD stone	CBD angle	-

Primary Outcome Measures

Name	Time	Method
The association between existence of periampullary diverticulum and recurrent CBD stone	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)

Secondary Outcome Measures

Name	Time	Method
The association between common bile duct angle and existence of recurrent CBD stone	retrospective (up to 8 years)	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)

Trial Locations

Locations (1)

Chuncheon Sacred Heart Hospital; 🇰🇷 Chuncheon, Gangwon-do, Korea, Republic of