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).

NCT01414400 | Completed Results DMC

• 1 other identifier: SU-07272011-8148
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Bile Duct Stricture; Choledocholithiasis

Keywords

Bacteremia; Spyglass; Cholangioscopy

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Bacteremia

  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.

  1 week

Study Arms (1)

Choledochoscopy

OTHER

Patients undergoing ERCP with choledochoscopy

Other: Blood draw for culture

Interventions

Blood draw for culture OTHER

Blood will be drawn and sent for culture.

Choledochoscopy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age \<18, \> 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

Sponsors & Collaborators

• Stanford University: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 26919263 RESULT

MeSH Terms

Conditions

Choledocholithiasis; Bacteremia

Interventions

Blood Specimen Collection; Culture Techniques

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; In Vitro Techniques

Results Point of Contact

• Title: Subhas Banerjee
• Organization: Stanford University School of Medicine

sbanerje@stanford.edu

650-723-2623

Study Officials

• Subhas Banerjee, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: August 11, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 14, 2025
• Results First Posted: March 14, 2025

Record last verified: 2025-02

Locations

US (1)