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Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD
This study has been completed.
Sponsor:
Texas Tech University Health Sciences Center, El Paso
Collaborator:
American College of Gastroenterology
Information provided by (Responsible Party):
Mohamed O Othman, Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier:
NCT01673269
First received: August 22, 2012
Last updated: May 15, 2017
Last verified: May 2017
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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: No masking Primary Purpose: Diagnostic |
| Official Title: | Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD |
Resource links provided by NLM:
Genetics Home Reference related topics:
cholangiocarcinoma
MedlinePlus related topics:
Health Checkup
U.S. FDA Resources
Further study details as provided by Mohamed O Othman, Texas Tech University Health Sciences Center, El Paso:
Primary Outcome Measures:
- the frequency of bacteremia after ERCP with direct cholangioscopic examination of the CBD [ Time Frame: 5 minutes and 30 minutes ]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
Secondary Outcome Measures:
- 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. ]This outcome will be obtained by calling the patient 24 hour and 1 week after the procedure
| Enrollment: | 60 |
| Study Start Date: | July 2012 |
| Study Completion Date: | October 2013 |
| Primary Completion Date: | October 2013 (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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01673269
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673269
Locations
| United States, Texas | |
| Texas Tech University Health Sciences Center at El Paso | |
| El Paso, Texas, United States, 79905 | |
Sponsors and Collaborators
Texas Tech University Health Sciences Center, El Paso
American College of Gastroenterology
Investigators
| Principal Investigator: | Mohamed O Othman, MD | Texas Tech University at El Paso |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mohamed O Othman, Assistant Professor, Texas Tech University Health Sciences Center, El Paso |
| ClinicalTrials.gov Identifier: | NCT01673269 History of Changes |
| Other Study ID Numbers: |
E12053-A |
| Study First Received: | August 22, 2012 |
| Last Updated: | May 15, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Mohamed O Othman, Texas Tech University Health Sciences Center, El Paso:
|
ERCP Direct cholangioscopic examination of the common bile duct Choledocholithiasis Cholangiocarcinoma Benign stricture of common bile duct |
Additional relevant MeSH terms:
|
Cholangiocarcinoma Bacteremia Constriction, Pathologic Choledocholithiasis Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Bacterial Infections Sepsis |
Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Pathological Conditions, Anatomical Common Bile Duct Diseases Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Cholelithiasis |
ClinicalTrials.gov processed this record on July 19, 2017