Clinical trial NCT02329977: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Common Bile Duct Gall Stones
Common Bile Duct GallStones
Keywords: duodenal-biliary reflux
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2015-01-01
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Duodenal-biliary reflux rate
timeFrame: up to 6 months
Secondary outcomes:
measure: Distal common bile duct angle
timeFrame: up to 6 months
measure: Maximal CBD diameter
timeFrame: up to 6 months
measure: Peripapillary diverticulum
timeFrame: up to 6 months
measure: Pneumobilia
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
References:
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citation: Zhang R, Luo H, Pan Y, Zhao L, Dong J, Liu Z, Wang X, Tao Q, Lu G, Guo X. Rate of duodenal-biliary reflux increases in patients with recurrent common bile duct stones: evidence from barium meal examination. Gastrointest Endosc. 2015 Oct;82(4):660-5. doi: 10.1016/j.gie.2015.03.1908. Epub 2015 May 5.