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
• Interventions: Other: standard barium meal examination

• 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

Arm && Interventions

Group	Intervention	Description
Recurrent group	standard barium meal examination	Patients with history of recurrent common bile duct stone after successfully ERCP stone remove.
Control group	standard barium meal examination	Patients without history of recurrent common bile duct stone after successfully ERCP stone remove.

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
Pneumobilia	up to 6 months	Pneumobilia were determined by CT
Maximal CBD diameter	up to 6 months	Maximal CBD diameter was determined by MRCP.
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.

Trial Locations

Locations (1)

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