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).
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Bile Duct Stricture Choledocholithiasis |
Other: Blood draw for culture |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Prospective Study of Bacteremia and Infection Rates Following Cholangioscopy With the Spyglass Cholangioscope |
- Bacteremia and Infection Rates following Cholangioscopy with the Spyglass cholangioscope [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- The frequency of cholangitis/sepsis despite use of post procedural antibiotics [ Time Frame: 1 week ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
-
Other: Blood draw for culture
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Subhas Banerjee, MD | 650-736-0431 | sbanerje@stanford.edu; |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Subhas Banerjee, MD sbanerje@stanford.edu | |
| Principal Investigator: Subhas Banerjee, MD | |
| Principal Investigator: | Subhas Banerjee, MD | Stanford University |
More Information
No publications provided
| Responsible Party: | Subhas Banerjee MD, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01414400 History of Changes |
| Other Study ID Numbers: | SU-07272011-8148 |
| Study First Received: | August 9, 2011 |
| Last Updated: | August 11, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Stanford University:
|
Bacteremia Spyglass Cholangioscopy |
Additional relevant MeSH terms:
|
Bacteremia Cholestasis Choledocholithiasis Constriction, Pathologic Bacterial Infections Sepsis Infection Systemic Inflammatory Response Syndrome |
Inflammation Pathologic Processes Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Common Bile Duct Diseases Cholelithiasis Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 22, 2013