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

This study has been completed.
Sponsor:
Collaborator:
American College of Gastroenterology
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01673269
First received: August 22, 2012
Last updated: November 25, 2013
Last verified: November 2013
  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

Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • 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


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. ] [ Designated as safety issue: Yes ]
    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
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
American College of Gastroenterology
Investigators
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: November 25, 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
Adenocarcinoma
Bacterial Infections
Bile Duct Diseases
Biliary Tract Diseases
Carcinoma
Cholelithiasis
Common Bile Duct Diseases
Digestive System Diseases
Infection
Inflammation
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on October 22, 2014