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

NCT02329977 | Completed DMC

• 1 other identifier: 20130508-2
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Bile Duct Gall Stones; Common Bile Duct GallStones

Keywords

duodenal-biliary reflux

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Distal common bile duct angle

  up to 6 months

• Maximal CBD diameter

  up to 6 months

• Peripapillary diverticulum

  up to 6 months

• Pneumobilia

  up to 6 months

Study Arms (2)

Recurrent group

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

Other: standard barium meal examination

Control group

Patients without history of recurrent common bile duct stone after successfully ERCP stone remove.

Other: standard barium meal examination

Interventions

standard barium meal examination OTHER

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

Control group; Recurrent group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with common bile duct stone underwent successful stone removal by ERCP in Xijing Hospital of Digestive Diseases.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Location

Related Publications (7)

• 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.

  PMID: 16813804 BACKGROUND

• 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.

  PMID: 16607138 BACKGROUND

• 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.

  PMID: 18493475 BACKGROUND

• 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.

  PMID: 11427840 BACKGROUND

• 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.

  PMID: 19539920 BACKGROUND

• 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.

  PMID: 12477771 BACKGROUND

• 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.

  PMID: 25952091 DERIVED

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: December 20, 2014
• First Posted: January 1, 2015
• Study Start: June 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: December 2, 2015

Record last verified: 2015-12

Locations

CN (1)