Know Cancer

or
forgot password

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

Thank you

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