search
Back to results

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

Primary Purpose

Choledocholithiasis, Cholangiocarcinoma, Benign Stricture of Common Bile Duct

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood culture ( aerobic and anaerobic)
Sponsored by
Texas Tech University Health Sciences Center, El Paso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Choledocholithiasis focused on measuring ERCP, Direct cholangioscopic examination of the common bile duct, Choledocholithiasis, Cholangiocarcinoma, Benign stricture of common bile duct

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Texas Tech University Health Sciences Center at El Paso

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ERCP with direct examination of the CBD

Arm Description

Outcomes

Primary Outcome Measures

the frequency of bacteremia after ERCP with direct cholangioscopic examination of the CBD
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
This outcome will be obtained by calling the patient 24 hour and 1 week after the procedure

Full Information

First Posted
August 22, 2012
Last Updated
May 15, 2017
Sponsor
Texas Tech University Health Sciences Center, El Paso
Collaborators
American College of Gastroenterology
search

1. Study Identification

Unique Protocol Identification Number
NCT01673269
Brief Title
Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD
Official Title
Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Tech University Health Sciences Center, El Paso
Collaborators
American College of Gastroenterology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choledocholithiasis, Cholangiocarcinoma, Benign Stricture of Common Bile Duct
Keywords
ERCP, Direct cholangioscopic examination of the common bile duct, Choledocholithiasis, Cholangiocarcinoma, Benign stricture of common bile duct

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ERCP with direct examination of the CBD
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Blood culture ( aerobic and anaerobic)
Intervention Description
Blood culture 5 minutes and 30 minutes after the procedure
Primary Outcome Measure Information:
Title
the frequency of bacteremia after ERCP with direct cholangioscopic examination of the CBD
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
Time Frame
5 minutes and 30 minutes
Secondary Outcome Measure Information:
Title
To measure the frequency of fever or sepsis after ERCP with direct cholangioscopic examination of the CBD
Description
This outcome will be obtained by calling the patient 24 hour and 1 week after the procedure
Time Frame
within 24 hours and one week of the procedures.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed O Othman, MD
Organizational Affiliation
Texas Tech University at El Paso
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Tech University Health Sciences Center at El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26116469
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs