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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Choledocholithiasis Cholangiocarcinoma Benign Stricture of Common Bile Duct

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ERCP with direct examination of the CBD

Group Type EXPERIMENTAL

Blood culture ( aerobic and anaerobic)

Intervention Type OTHER

Blood culture 5 minutes and 30 minutes after the procedure

Interventions

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Blood culture ( aerobic and anaerobic)

Blood culture 5 minutes and 30 minutes after the procedure

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No