Trial Outcomes & Findings for 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). (NCT NCT01414400)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

72 participants

Primary outcome timeframe

1 week

Results posted on

2025-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	Choledochoscopy Patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) with choledochoscopy Blood draw for culture: Blood drawn and sent for culture.
Overall Study STARTED	72
Overall Study COMPLETED	72
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Choledochoscopy n=72 Participants Patients undergoing ERCP with choledochoscopy Blood draw for culture: Blood will be drawn and sent for culture.
Age, Continuous	64.5 years STANDARD_DEVIATION 18 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Region of Enrollment United States	72 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Choledochoscopy n=72 Participants Patients undergoing ERCP with choledochoscopy Blood draw for culture: Blood drawn and sent for culture.
Number of Patients With Bacteremia Had positive blood culture	25 Participants
Number of Patients With Bacteremia Had true positive blood culture after ERCP/SOC	20 Participants
Number of Patients With Bacteremia Had false positive blood culture due to contaminants	5 Participants
Number of Patients With Bacteremia Had bacteremia following cholangioscopy	10 Participants
Number of Patients With Bacteremia Had bacteremia following ERCP alone	10 Participants
Number of Patients With Bacteremia Had sustained bacteremia following ERCP/Cholangioscopy	14 Participants

Adverse Events

Choledochoscopy

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Choledochoscopy n=72 participants at risk Patients undergoing ERCP with choledochoscopy Blood draw for culture: Blood drawn and sent for culture.
Infections and infestations Bacteremia	27.8% 20/72 • Up to 2 months

Additional Information

Subhas Banerjee

Stanford University School of Medicine

Phone: 650-723-2623

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place