CompletedNot Applicable

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).

United States72 participantsStarted 2011-08

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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 \<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

What they're measuring

Number of Patients With Bacteremia

Timeframe: 1 week

Trial details

NCT IDNCT01414400

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-08

Results submitted2019-04-02

View on ClinicalTrials.gov More Bile Duct Stricture trials