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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).

Primary Purpose

Bile Duct Stricture, Choledocholithiasis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood draw for culture
Sponsored by
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bile Duct Stricture focused on measuring Bacteremia, Spyglass, Cholangioscopy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University School of MedicineRecruiting

Outcomes

Primary Outcome Measures

Bacteremia and Infection Rates following Cholangioscopy with the Spyglass cholangioscope

Secondary Outcome Measures

The frequency of cholangitis/sepsis despite use of post procedural antibiotics

Full Information

First Posted
August 9, 2011
Last Updated
August 11, 2011
Sponsor
Stanford University
Collaborators
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01414400
Brief Title
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).
Official Title
Prospective Study of Bacteremia and Infection Rates Following Cholangioscopy With the Spyglass Cholangioscope
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Stanford University
Collaborators
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Duct Stricture, Choledocholithiasis
Keywords
Bacteremia, Spyglass, Cholangioscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Blood draw for culture
Intervention Description
Blood will be drawn and sent for culture.
Primary Outcome Measure Information:
Title
Bacteremia and Infection Rates following Cholangioscopy with the Spyglass cholangioscope
Time Frame
1 week
Secondary Outcome Measure Information:
Title
The frequency of cholangitis/sepsis despite use of post procedural antibiotics
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80 Biliary disease such as large stones necessitating electrohydraulic lithotripsy; Biliary strictures needing tissue acquisition through cholangioscopic directed biopsies Pancreatic-biliary malignancies needing tissue acquisition through cholangioscopic directed biopsies Willing and able to comply with the study procedures and provide written informed consent to participate in the study. Exclusion Criteria: Age <18, > 80 Potentially vulnerable subjects including pregnant women, homeless people, employees and students. Patients who have a clear indication for pre-procedure antibiotics based on current ASGE guidelines Patients who had received antibiotics for any reason within the prior 7 days Patients who had evidence of systemic infection at time of the ERCP Patients in whom additional venous access for blood cultures cannot be established. Participation in another investigational study within the previous 90 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Subhas Banerjee, MD
Phone
650-736-0431
Email
sbanerje@stanford.edu;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Subhas Banerjee, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Subhas Banerjee, MD
Email
sbanerje@stanford.edu
First Name & Middle Initial & Last Name & Degree
Subhas Banerjee, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
26919263
Citation
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.
Results Reference
derived

Learn more about this 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).

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