Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD
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Purpose
When a doctor performs Endoscopic retrograde cholangiopancreatography "ERCP" (Endoscopy to examine the bile duct) a flexible tube is inserted into the mouth and into the stomach. The tube passes beyond the stomach and into an opening in the liver called the bile duct. Another small flexible endoscope is inserted inside the ERCP scope to directly visualize the bile duct to ensure that there are no cancers or stones in the bile duct and occasionally to take a sample from the bile duct. The purpose of our study is to examine wither performing this procedure can transmit bacteria from the bile duct to the main blood stream.
| Condition | Intervention |
|---|---|
|
Choledocholithiasis Cholangiocarcinoma Benign Stricture of Common Bile Duct |
Other: Blood culture ( aerobic and anaerobic) |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD |
- the frequency of bacteremia after ERCP with direct cholangioscopic examination of the CBD [ Time Frame: 5 minutes and 30 minutes ] [ Designated as safety issue: Yes ]To measure the frequency of bacteremia after ERCP with direct cholangioscopic examination of the CBD by obtaining blood culture 5 minutes and 30 minutes after the procedure
- To measure the frequency of fever or sepsis after ERCP with direct cholangioscopic examination of the CBD [ Time Frame: within 24 hours and one week of the procedures. ] [ Designated as safety issue: Yes ]This outcome will be obtained by calling the patient 24 hour and 1 week after the procedure
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ERCP with direct examination of the CBD |
Other: Blood culture ( aerobic and anaerobic)
Blood culture 5 minutes and 30 minutes after the procedure
|
Detailed Description:
This is a prospective study to measure the frequency of bacteremia in patients undergoing ERCP with direct cholangioscopic examination of the Common Bile Duct "CBD". A blood culture will be drawn from patients prior to the procedure, 5 minutes after the procedure and 30 minutes after the procedure. The patient will be followed up for 7 days after procedure for fever and sepsis. The estimated sample size is 60 patients.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1- Adult patients (18-80) who are undergoing ERCP with direct cholangioscopic examination of the common bile duct to ensure the clearance of the common bile duct from stones.
2- Adult patients (18-80) who are undergoing ERCP with direct cholangioscopic examination of the common bile duct for stone removal.
3- Adult patients (18-80) who are undergoing ERCP with direct cholangioscopic examination of the common bile duct for tissue acquisition from the common bile duct mass.
4- Adult patients (18-80) who are undergoing ERCP with direct cholangioscopic examination of the common bile duct for tissue acquisition from common bile duct strictures.
Exclusion Criteria:
- 1- Patients younger than 18 yrs old or older than 80 yrs. 2- Pregnant patients. 3- Patient with ascending cholangitis, pneumonia or urinary tract infection 4- Patients who received antibiotics in the last 2 weeks prior to the procedure.
Contacts and Locations| Contact: Mohamed o Othman, MD | 915-545-6640 | mohamed.othman@ttuhsc.edu |
| Contact: Mark Zuckerman, MD | 915-545-6640 | mark.zuckerman@ttuhsc.edu |
| United States, Texas | |
| Texas Tech University at El Paso | Recruiting |
| El Paso, Texas, United States, 79905 | |
| Contact: Mohamed O Othman, MD 915-545-6640 mohamed.othman@ttuhsc.edu | |
| Principal Investigator: Mohamed O Othman, MD | |
| Sub-Investigator: Mark Zuckerman, MD | |
| Sub-Investigator: Brian Davis, MD | |
| Sub-Investigator: Richard Guerrero, MD | |
| Principal Investigator: | Mohamed O Othman, MD | Texas Tech University at El Paso |
More Information
No publications provided
| Responsible Party: | Texas Tech University Health Sciences Center |
| ClinicalTrials.gov Identifier: | NCT01673269 History of Changes |
| Other Study ID Numbers: | E12053-A |
| Study First Received: | August 22, 2012 |
| Last Updated: | April 17, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Texas Tech University Health Sciences Center:
|
ERCP Direct cholangioscopic examination of the common bile duct Choledocholithiasis Cholangiocarcinoma Benign stricture of common bile duct |
Additional relevant MeSH terms:
|
Bacteremia Cholangiocarcinoma Choledocholithiasis Constriction, Pathologic Bacterial Infections Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Adenocarcinoma |
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Common Bile Duct Diseases Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Cholelithiasis Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on June 18, 2013