Clinical Trial: Prospective Study to Investigate the Frequency of Possible Bacterial Entry Into the Bloodstream (Bacteremia) and Infectious Complications Associated With the Use of the Spyglass Cholangioscopy System During ERCP (Endoscopic Retrograde Cholangiopancreatography).

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Prospective Study of Bacteremia and Infection Rates Following Cholangioscopy With the Spyglass Cholangioscope

Brief Summary: The aim of this study is to prospectively evaluate the frequency of bacteremia after ERCP/cholangioscopy using the Spyglass Direct Visualization System. In addition, the frequency of cholangitis/sepsis despite use of post procedural antibiotics will be studied.

Detailed Summary:

Rates of bacteremia (bacterial seeding of the blood) following ERCP's range from 6.4% to 18.0%. However, infectious complications of cholangitis/sepsis occur in only 0.5%- 3.0% of patients undergoing this procedure. The Spyglass Direct Visualization System allows cholangioscopy with direct visualization of the bile duct during ERCP by using a specialized small caliber endoscope. During the Spyglass portion of the procedure, saline is introduced into the bile duct to to irrigate the biliary system, in order to distend the biliary ducts and to improve visualization by clearing contrast, pus and stone debris. Saline irrigation may increase intrabiliary pressures and may therefore theoretically increase the risk for bacteremia and infection.

The effect of Spyglass cholangioscopy and biliary irrigation on the frequency of bacteremia/post cholangioscopy infections is unknown and has not previously been studied.

The aim of this study is to prospectively evaluate the frequency of bacteremia after ERCP/cholangioscopy using the Spyglass system.

Sponsor: Stanford University

Current Primary Outcome: Bacteremia and Infection Rates following Cholangioscopy with the Spyglass cholangioscope [ Time Frame: 1 week ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The frequency of cholangitis/sepsis despite use of post procedural antibiotics [ Time Frame: 1 week ]

Original Secondary Outcome: Same as current

Information By: Stanford University

Dates:
Date Received: August 9, 2011
Date Started: August 2011
Date Completion: May 2012
Last Updated: August 11, 2011
Last Verified: August 2011