Clinical trial NCT01414400: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bile Duct Stricture
Choledocholithiasis
Keywords: Bacteremia
Spyglass
Cholangioscopy
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2011-08-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients With Bacteremia
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Subhas Banerjee, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.