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Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD


N/A
18 Years
80 Years
Open (Enrolling)
Both
Choledocholithiasis, Cholangiocarcinoma, Benign Stricture of Common Bile Duct

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Trial Information

Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD


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.


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

the frequency of bacteremia after ERCP with direct cholangioscopic examination of the CBD

Outcome Description:

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

Outcome Time Frame:

5 minutes and 30 minutes

Safety Issue:

Yes

Principal Investigator

Mohamed O Othman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Texas Tech University at El Paso

Authority:

United States: Institutional Review Board

Study ID:

E12053-A

NCT ID:

NCT01673269

Start Date:

July 2012

Completion Date:

October 2014

Related Keywords:

  • Choledocholithiasis
  • Cholangiocarcinoma
  • Benign Stricture of Common Bile Duct
  • ERCP
  • Direct cholangioscopic examination of the common bile duct
  • Choledocholithiasis
  • Cholangiocarcinoma
  • Benign stricture of common bile duct
  • Bacteremia
  • Cholangiocarcinoma
  • Choledocholithiasis
  • Constriction, Pathologic

Name

Location
Texas Tech University at El Paso El Paso, Texas  79905