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).

Choledocholithiasis Clinical Trial

Official title:

Prospective Study of Bacteremia and Infection Rates Following Cholangioscopy With the Spyglass Cholangioscope

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01414400
• Other study ID #: SU-07272011-8148
• Status: Recruiting
• Phase: N/A
• First received: August 9, 2011
• Last updated: August 11, 2011
• Start date: August 2011
• Est. completion date: May 2012

Study information

• Verified date: August 2011
• Source: Stanford University
• Contact: Subhas Banerjee, MD
• Phone: 650-736-0431
• Email: sbanerje[@]stanford.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bacteremia
• Bile Duct Stricture
• Choledocholithiasis

Intervention

Other:
• Blood draw for culture
Blood will be drawn and sent for culture.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacteremia and Infection Rates following Cholangioscopy with the Spyglass cholangioscope		1 week	No
Secondary	The frequency of cholangitis/sepsis despite use of post procedural antibiotics		1 week	No