Bile Duct Stricture, Choledocholithiasis
Conditions
Keywords
Bacteremia, Spyglass, Cholangioscopy
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.
Interventions
OTHERBlood draw for culture
Blood will be drawn and sent for culture.
Sponsors
Boston Scientific Corporation
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Bacteremia | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Choledochoscopy Patients undergoing ERCP with choledochoscopy
Blood draw for culture: Blood will be drawn and sent for culture. | 72 |
| Total | 72 |
Baseline characteristics
| Characteristic | Choledochoscopy |
|---|---|
| Age, Continuous | 64.5 years STANDARD_DEVIATION 18 |
| Region of Enrollment United States | 72 participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 72 |
| other Total, other adverse events | 20 / 72 |
| serious Total, serious adverse events | 0 / 72 |
Outcome results
Primary
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.
Time frame: 1 week
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Choledochoscopy | Number of Patients With Bacteremia | Had positive blood culture | 25 Participants |
| Choledochoscopy | Number of Patients With Bacteremia | Had true positive blood culture after ERCP/SOC | 20 Participants |
| Choledochoscopy | Number of Patients With Bacteremia | Had false positive blood culture due to contaminants | 5 Participants |
| Choledochoscopy | Number of Patients With Bacteremia | Had bacteremia following cholangioscopy | 10 Participants |
| Choledochoscopy | Number of Patients With Bacteremia | Had bacteremia following ERCP alone | 10 Participants |
| Choledochoscopy | Number of Patients With Bacteremia | Had sustained bacteremia following ERCP/Cholangioscopy | 14 Participants |