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

Common Bile Duct GallStones Clinical Trial

Official title:

Rate of Duodenal-biliary Reflux Increases in Patients With Recurrent Common Bile Duct Stones: Direct Evidence From Barium Meal Examination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02329977
• Other study ID #: 20130508-2
• Status: Completed
• Phase: N/A
• First received: December 20, 2014
• Last updated: December 1, 2015
• Start date: June 2013
• Est. completion date: January 2014

Study information

• Verified date: December 2015
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Gastrointest Endosc 2002 Jan;55(1):144. Chol WB [corrected to Choi WB]. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duodenal-biliary reflux rate	The proportion of patients with barium reflux into bile duct during the standard barium meal examination.	up to 6 months	Yes
Secondary	Distal common bile duct angle	MRCP revealed the first angulation from the ampullary orifice along the course of the common bile duct stone.	up to 6 months	No
Secondary	Maximal CBD diameter	Maximal CBD diameter was determined by MRCP.	up to 6 months	No
Secondary	Peripapillary diverticulum	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.	up to 6 months	No
Secondary	Pneumobilia	Pneumobilia were determined by CT	up to 6 months	No