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

Study Overview
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Brief Summary
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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.

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

Conditions
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Common Bile Duct Gall Stones, Common Bile Duct GallStones

Intervention / Treatment
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* Other: standard barium meal examination


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Recurrent group<br>Patients with history of recurrent common bile duct stone after successfully ERCP stone remove. | Other: standard barium meal examination<br>* All eligible patients received standard barium meal examination, MRCP and enhanced abdominal CT.<br>|
| Control group<br>Patients without history of recurrent common bile duct stone after successfully ERCP stone remove. | Other: standard barium meal examination<br>* All eligible patients received standard barium meal examination, MRCP and enhanced abdominal CT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duodenal-biliary reflux rate | The proportion of patients with barium reflux into bile duct during the standard barium meal examination. | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distal common bile duct angle | MRCP revealed the first angulation from the ampullary orifice along the course of the common bile duct stone. | up to 6 months | 
| Maximal CBD diameter | Maximal CBD diameter was determined by MRCP. | up to 6 months | 
| Peripapillary diverticulum | 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. | up to 6 months | 
| Pneumobilia | Pneumobilia were determined by CT | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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duodenal-biliary reflux