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).

August 11, 2011 updated by: Stanford University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University School of Medicine
        • Principal Investigator:
          • Subhas Banerjee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bacteremia and Infection Rates following Cholangioscopy with the Spyglass cholangioscope
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
The frequency of cholangitis/sepsis despite use of post procedural antibiotics
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Subhas Banerjee, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ANTICIPATED)

May 1, 2012

Study Completion (ANTICIPATED)

May 1, 2012

Study Registration Dates

First Submitted

August 9, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (ESTIMATE)

August 11, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 12, 2011

Last Update Submitted That Met QC Criteria

August 11, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-07272011-8148

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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