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

Rate of Duodenal-biliary Reflux Increases in Patients With Recurrent Common Bile Duct Stones: Direct Evidence From Barium Meal Examination

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02329977
Enrollment
64
Registered
2015-01-01
Start date
2013-06-30
Completion date
2014-01-31
Last updated
2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common Bile Duct GallStones, Common Bile Duct Gall Stones

Keywords

duodenal-biliary reflux

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.

Interventions

OTHERstandard barium meal examination

All eligible patients received standard barium meal examination, MRCP and enhanced abdominal CT.

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Duodenal-biliary reflux rateup to 6 monthsThe proportion of patients with barium reflux into bile duct during the standard barium meal examination.

Secondary

MeasureTime frameDescription
Distal common bile duct angleup to 6 monthsMRCP revealed the first angulation from the ampullary orifice along the course of the common bile duct stone.
Maximal CBD diameterup to 6 monthsMaximal CBD diameter was determined by MRCP.
Peripapillary diverticulumup to 6 monthsPeripapillary 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.
Pneumobiliaup to 6 monthsPneumobilia were determined by CT

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026