Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD - Full Text View

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

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 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 ] [ 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 (Adult, Senior)
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, 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):

Othman MO, Guerrero R, Elhanafi S, Davis B, Hernandez J, Houle J, Mallawaarachchi I, Dwivedi AK, Zuckerman MJ. A prospective study of the risk of bacteremia in directed cholangioscopic examination of the common bile duct. Gastrointest Endosc. 2016 Jan;83(1):151-7. doi: 10.1016/j.gie.2015.05.018. Epub 2015 Jun 23.


Responsible Party:	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:	July 22, 2016
Health Authority:	United States: Institutional Review Board

Keywords provided by 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 September 23, 2016