Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD
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ClinicalTrials.gov Identifier: NCT01673269 |
Recruitment Status
:
Completed
First Posted
: August 27, 2012
Last Update Posted
: May 17, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Choledocholithiasis Cholangiocarcinoma Benign Stricture of Common Bile Duct | Other: Blood culture ( aerobic and anaerobic) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD |
Study Start Date : | July 2012 |
Actual Primary Completion Date : | October 2013 |
Actual Study Completion Date : | October 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: ERCP with direct examination of the CBD |
Other: Blood culture ( aerobic and anaerobic)
Blood culture 5 minutes and 30 minutes after the procedure
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- 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
- 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

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673269
United States, Texas | |
Texas Tech University Health Sciences Center at El Paso | |
El Paso, Texas, United States, 79905 |
Principal Investigator: | Mohamed O Othman, MD | Texas Tech University at El Paso |
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 |
First Posted: | August 27, 2012 Key Record Dates |
Last Update Posted: | May 17, 2017 |
Last Verified: | May 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 |