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

• Sponsor: Air Force Military Medical University, China (Other)
• Overall Status: Completed
• CT.gov ID: NCT02329977
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Duration (Months): 7
• Patients Per Site Per Month: 9.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Common Bile Duct Gall Stones; Common Bile Duct GallStones	Other: standard barium meal examination

Study Design

• Study Type: Observational
• Actual Enrollment: 64 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Rate of Duodenal-biliary Reflux Increases in Patients With Recurrent Common Bile Duct Stones: Direct Evidence From Barium Meal Examination
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Recurrent group Patients with history of recurrent common bile duct stone after successfully ERCP stone remove.	Other: standard barium meal examination; 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.	Other: standard barium meal examination; All eligible patients received standard barium meal examination, MRCP and enhanced abdominal CT.

Outcome Measures

Primary Outcome Measures

1. Duodenal-biliary reflux rate [up to 6 months]

   The proportion of patients with barium reflux into bile duct during the standard barium meal examination.

Secondary Outcome Measures

1. Distal common bile duct angle [up to 6 months]

   MRCP revealed the first angulation from the ampullary orifice along the course of the common bile duct stone.

2. Maximal CBD diameter [up to 6 months]

   Maximal CBD diameter was determined by MRCP.

3. Peripapillary diverticulum [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.

4. Pneumobilia [up to 6 months]

   Pneumobilia were determined by CT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi	China	710032

Sponsors and Collaborators

• Air Force Military Medical University, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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].
• 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.

• Responsible Party: Yanglin Pan, Associated professor, Air Force Military Medical University, China
• ClinicalTrials.gov Identifier: NCT02329977
• Other Study ID Numbers: 20130508-2
• First Posted: Jan 1, 2015
• Last Update Posted: Dec 2, 2015
• Last Verified: Dec 1, 2015

• Keywords provided by Yanglin Pan, Associated professor, Air Force Military Medical University, China: duodenal-biliary reflux
• Additional relevant MeSH terms: Gallstones

Study Results

No Results Posted as of Dec 2, 2015