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 because the information has not been verified recently.
Verified August 2011 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01414400
First received: August 9, 2011
Last updated: August 11, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Bile Duct Stricture
Choledocholithiasis
Other: Blood draw for culture

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Study of Bacteremia and Infection Rates Following Cholangioscopy With the Spyglass Cholangioscope

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Bacteremia and Infection Rates following Cholangioscopy with the Spyglass cholangioscope [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The frequency of cholangitis/sepsis despite use of post procedural antibiotics [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Blood draw for culture
    Blood will be drawn and sent for culture.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414400

Contacts
Contact: Subhas Banerjee, MD 650-736-0431 sbanerje@stanford.edu;

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Subhas Banerjee, MD       sbanerje@stanford.edu   
Principal Investigator: Subhas Banerjee, MD         
Sponsors and Collaborators
Stanford University
Boston Scientific Corporation
Investigators
Principal Investigator: Subhas Banerjee, MD Stanford University
  More Information

No publications provided

Responsible Party: Subhas Banerjee MD, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01414400     History of Changes
Other Study ID Numbers: SU-07272011-8148
Study First Received: August 9, 2011
Last Updated: August 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Bacteremia
Spyglass
Cholangioscopy

Additional relevant MeSH terms:
Common Bile Duct Diseases
Bile Duct Diseases
Bacteremia
Choledocholithiasis
Constriction, Pathologic
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 21, 2014