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

NCT ID: NCT02329977

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-01-31

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.

Detailed Description

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Conditions

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Common Bile Duct Gall Stones Common Bile Duct GallStones

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Recurrent group

Patients with history of recurrent common bile duct stone after successfully ERCP stone remove.

standard barium meal examination

Intervention Type OTHER

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.

standard barium meal examination

Intervention Type OTHER

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

Interventions

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standard barium meal examination

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

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Yanglin Pan

Associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Site Status

Countries

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China

References

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Keizman D, Ish Shalom M, Konikoff FM. Recurrent symptomatic common bile duct stones after endoscopic stone extraction in elderly patients. Gastrointest Endosc. 2006 Jul;64(1):60-5. doi: 10.1016/j.gie.2006.01.022.

Reference Type BACKGROUND
PMID: 16813804 (View on PubMed)

Cheon YK, Lehman GA. Identification of risk factors for stone recurrence after endoscopic treatment of bile duct stones. Eur J Gastroenterol Hepatol. 2006 May;18(5):461-4. doi: 10.1097/00042737-200605000-00001.

Reference Type BACKGROUND
PMID: 16607138 (View on PubMed)

Ishiguro J. Biliary bacteria as an indicator of the risk of recurrence of choledocholithiasis after endoscopic sphincterotomy. Diagn Ther Endosc. 1998;5(1):9-17. doi: 10.1155/DTE.5.9.

Reference Type BACKGROUND
PMID: 18493475 (View on PubMed)

Kim DI, Kim MH, Lee SK, Seo DW, Choi WB, Lee SS, Park HJ, Joo YH, Yoo KS, Kim HJ, Min YI. Risk factors for recurrence of primary bile duct stones after endoscopic biliary sphincterotomy. Gastrointest Endosc. 2001 Jul;54(1):42-8. doi: 10.1067/mge.2001.115335.

Reference Type BACKGROUND
PMID: 11427840 (View on PubMed)

Misra SP, Dwivedi M. Reflux of duodenal contents and cholangitis in patients undergoing self-expanding metal stent placement. Gastrointest Endosc. 2009 Aug;70(2):317-21. doi: 10.1016/j.gie.2008.12.054. Epub 2009 Jun 21.

Reference Type BACKGROUND
PMID: 19539920 (View on PubMed)

Ando T, Tsuyuguchi T, Okugawa T, Saito M, Ishihara T, Yamaguchi T, Saisho H. Risk factors for recurrent bile duct stones after endoscopic papillotomy. Gut. 2003 Jan;52(1):116-21. doi: 10.1136/gut.52.1.116.

Reference Type BACKGROUND
PMID: 12477771 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25952091 (View on PubMed)

Other Identifiers

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20130508-2

Identifier Type: -

Identifier Source: org_study_id