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).

Not Applicable

Completed

• Conditions: Bile Duct Stricture; Choledocholithiasis

• Registration Number: NCT01414400
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Primary Completion: 2015-08
• Study Completion: 2015-12
• Results First Submitted: 2019-04-02
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-21
• Last Update Submitted: 2025-02-21
• Results First Posted: 2025-03-14
• Last Update Posted: 2025-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Patients With Bacteremia	1 week	This outcome is to assess bacteremia and infection rates in patients following Cholangioscopy with the Spyglass cholangioscope. Positive blood cultures were evaluated for transient ERCP-related bacteremia, and sustained Cholangioscopy-related bacteremia, defined by negative first and second sets of blood cultures but a positive third blood culture obtained 15 minutes after completion of Cholangioscopy and ERCP.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States