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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 recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Stanford University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01414400
First Posted: August 11, 2011
Last Update Posted: August 12, 2011
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.
Collaborator:
Boston Scientific Corporation
Information provided by:
Stanford University
August 9, 2011
August 11, 2011
August 12, 2011
August 2011
May 2012   (Final data collection date for primary outcome measure)
Bacteremia and Infection Rates following Cholangioscopy with the Spyglass cholangioscope [ Time Frame: 1 week ]
Same as current
Complete list of historical versions of study NCT01414400 on ClinicalTrials.gov Archive Site
The frequency of cholangitis/sepsis despite use of post procedural antibiotics [ Time Frame: 1 week ]
Same as current
Not Provided
Not Provided
 
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).
Prospective Study of Bacteremia and Infection Rates Following Cholangioscopy With the Spyglass Cholangioscope
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Bile Duct Stricture
  • Choledocholithiasis
Other: Blood draw for culture
Blood will be drawn and sent for culture.
Not Provided
Thosani N, Zubarik RS, Kochar R, Kothari S, Sardana N, Nguyen T, Banerjee S. Prospective evaluation of bacteremia rates and infectious complications among patients undergoing single-operator choledochoscopy during ERCP. Endoscopy. 2016 May;48(5):424-31. doi: 10.1055/s-0042-101407. Epub 2016 Feb 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
May 2012
May 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 18-80
  2. Biliary disease such as large stones necessitating electrohydraulic lithotripsy;
  3. Biliary strictures needing tissue acquisition through cholangioscopic directed biopsies
  4. Pancreatic-biliary malignancies needing tissue acquisition through cholangioscopic directed biopsies
  5. Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

  1. Age <18, > 80
  2. Potentially vulnerable subjects including pregnant women, homeless people, employees and students.
  3. Patients who have a clear indication for pre-procedure antibiotics based on current ASGE guidelines
  4. Patients who had received antibiotics for any reason within the prior 7 days
  5. Patients who had evidence of systemic infection at time of the ERCP
  6. Patients in whom additional venous access for blood cultures cannot be established.
  7. Participation in another investigational study within the previous 90 days
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01414400
SU-07272011-8148
Yes
Not Provided
Not Provided
Subhas Banerjee MD, Stanford University School of Medicine
Stanford University
Boston Scientific Corporation
Principal Investigator: Subhas Banerjee, MD Stanford University
Stanford University
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP