Rate of Duodenal-biliary Reflux Increases in Patients With Recurrent Common Bile Duct Stones

Completed

• Conditions: Common Bile Duct Gall Stones; Common Bile Duct GallStones

• Registration Number: NCT02329977
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

ERCP is the primary choice for removal of common bile duct stone (CBDS) currently. However, 4-24% patients underwent recurrence after successful clearance of CBDS. Stone re-formation due to chronic inflammation of biliary duct is generally considered an important cause of CBDS recurrence, which is associated with duodenal-biliary reflux (DBR) after sphincterotomy. Although it was believed that DBR was the important cause of CBDS recurrence, the direct evidence was still lacking. Here we conducted a case control study to investigate the DBR rate in patients with recurrent CBDS after ERCP.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Study First Submitted: 2014-12-20
• Study First Submitted QC: 2014-12-31
• Study First Posted: 2015-01-01
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Patients with common bile duct stone underwent successful stone removal by ERCP in Xijing Hospital of Digestive Diseases.

Exclusion Criteria

• Gallbladder stones or hepatolithiasis;
• Stenosis of biliary duct;
• Incomplete common bile duct stone removal by ERCP;
• Common bile duct stent;
• Unable to provide informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duodenal-biliary reflux rate	up to 6 months	The proportion of patients with barium reflux into bile duct during the standard barium meal examination.

Secondary Outcome Measures

Name	Time	Method
Distal common bile duct angle	up to 6 months	MRCP revealed the first angulation from the ampullary orifice along the course of the common bile duct stone.
Peripapillary diverticulum	up to 6 months	Peripapillary diverticulum was defined endoscopically as the presence of a diverticulum within a 2-cm radius from the papilla and was divided into 2 types in terms of the relation between the papilla and diverticulum: type A, papilla located on the inner rim of the diverticulum or papilla located deep within the diverticulum; and type B, papilla located outside the diverticulum.
Pneumobilia	up to 6 months	Pneumobilia were determined by CT
Maximal CBD diameter	up to 6 months	Maximal CBD diameter was determined by MRCP.

Trial Locations

Locations (1)

Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China