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

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ClinicalTrials.gov Identifier: NCT02329977
Recruitment Status : Completed
First Posted : January 1, 2015
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Fourth Military Medical University

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.

Condition or disease Intervention/treatment
Common Bile Duct Gall Stones Common Bile Duct GallStones Other: standard barium meal examination

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Study Type : Observational
Actual Enrollment : 64 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Rate of Duodenal-biliary Reflux Increases in Patients With Recurrent Common Bile Duct Stones: Direct Evidence From Barium Meal Examination
Study Start Date : June 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
Drug Information available for: Barium

Group/Cohort Intervention/treatment
Recurrent group
Patients with history of recurrent common bile duct stone after successfully ERCP stone remove.
Other: standard barium meal examination
All eligible patients received standard barium meal examination, MRCP and enhanced abdominal CT.

Control group
Patients without history of recurrent common bile duct stone after successfully ERCP stone remove.
Other: standard barium meal examination
All eligible patients received standard barium meal examination, MRCP and enhanced abdominal CT.




Primary Outcome Measures :
  1. Duodenal-biliary reflux rate [ Time Frame: up to 6 months ]
    The proportion of patients with barium reflux into bile duct during the standard barium meal examination.


Secondary Outcome Measures :
  1. Distal common bile duct angle [ Time Frame: up to 6 months ]
    MRCP revealed the first angulation from the ampullary orifice along the course of the common bile duct stone.

  2. Maximal CBD diameter [ Time Frame: up to 6 months ]
    Maximal CBD diameter was determined by MRCP.

  3. Peripapillary diverticulum [ Time Frame: 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.

  4. Pneumobilia [ Time Frame: up to 6 months ]
    Pneumobilia were determined by CT



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with history of recurrent common bile duct stone (recurrent group) and non-recurrent common bile duct stone (control group) in Xijing Hospital of Digestive Diseases were invited to participate the study. All the patients underwent successful stone removal by ERCP previously. Patients in the control group were matched with the recurrence group by age and gender at 1:1 ratio.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329977


Locations
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China, Shaanxi
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Fourth Military Medical University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yanglin Pan, Associated professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT02329977    
Other Study ID Numbers: 20130508-2
First Posted: January 1, 2015    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: December 2015
Keywords provided by Yanglin Pan, Fourth Military Medical University:
duodenal-biliary reflux
Additional relevant MeSH terms:
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Gallstones
Calculi
Pathological Conditions, Anatomical
Cholelithiasis
Biliary Tract Diseases
Digestive System Diseases
Cholecystolithiasis
Gallbladder Diseases