N/A N=72 Diagnostic

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).

Bile Duct Stricture · Choledocholithiasis

Bottom Line

View on ClinicalTrials.gov: NCT01414400 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Number of Patients With Bacteremia — 25; 20; 5; 10 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Blood draw for culture (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Bacteremia	25; 20; 5; 10; 10; 14	—

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.

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01414400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.