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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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, Air Force Military Medical University, China

Tracking Information
First Submitted Date December 20, 2014
First Posted Date January 1, 2015
Last Update Posted Date December 2, 2015
Study Start Date June 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 31, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 31, 2014)
  • 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.
  • Maximal CBD diameter [ Time Frame: up to 6 months ]
    Maximal CBD diameter was determined by MRCP.
  • 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.
  • Pneumobilia [ Time Frame: up to 6 months ]
    Pneumobilia were determined by CT
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Rate of Duodenal-biliary Reflux Increases in Patients With Recurrent Common Bile Duct Stones
Official Title Rate of Duodenal-biliary Reflux Increases in Patients With Recurrent Common Bile Duct Stones: Direct Evidence From Barium Meal Examination
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 Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Common Bile Duct Gall Stones
  • Common Bile Duct GallStones
Intervention Other: standard barium meal examination
All eligible patients received standard barium meal examination, MRCP and enhanced abdominal CT.
Study Groups/Cohorts
  • Recurrent group
    Patients with history of recurrent common bile duct stone after successfully ERCP stone remove.
    Intervention: Other: standard barium meal examination
  • Control group
    Patients without history of recurrent common bile duct stone after successfully ERCP stone remove.
    Intervention: Other: standard barium meal examination
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 31, 2014)
64
Original Actual Enrollment Same as current
Actual Study Completion Date January 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02329977
Other Study ID Numbers 20130508-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Yanglin Pan, Air Force Military Medical University, China
Study Sponsor Air Force Military Medical University, China
Collaborators Not Provided
Investigators Not Provided
PRS Account Air Force Military Medical University, China
Verification Date December 2015