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).
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01414400|
Recruitment Status : Unknown
Verified August 2011 by Stanford University.
Recruitment status was: Recruiting
First Posted : August 11, 2011
Last Update Posted : August 12, 2011
|Condition or disease||Intervention/treatment||Phase|
|Bile Duct Stricture Choledocholithiasis||Other: Blood draw for culture||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Study of Bacteremia and Infection Rates Following Cholangioscopy With the Spyglass Cholangioscope|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||May 2012|
|Estimated Study Completion Date :||May 2012|
- Other: Blood draw for culture
Blood will be drawn and sent for culture.
- Bacteremia and Infection Rates following Cholangioscopy with the Spyglass cholangioscope [ Time Frame: 1 week ]
- The frequency of cholangitis/sepsis despite use of post procedural antibiotics [ Time Frame: 1 week ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414400
|Contact: Subhas Banerjee, MDfirstname.lastname@example.org;|
|United States, California|
|Stanford University School of Medicine||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Subhas Banerjee, MD email@example.com|
|Principal Investigator: Subhas Banerjee, MD|
|Principal Investigator:||Subhas Banerjee, MD||Stanford University|