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

Study Overview
=================
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.

Official Title
-----------------
Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD

Conditions
-----------------
Choledocholithiasis, Cholangiocarcinoma, Benign Stricture of Common Bile Duct

Intervention / Treatment
-----------------
* Other: Blood culture ( aerobic and anaerobic)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERCP with direct examination of the CBD<br> | Other: Blood culture ( aerobic and anaerobic)<br>* Blood culture 5 minutes and 30 minutes after the procedure<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5 minutes and 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | within 24 hours and one week of the procedures. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERCP, Direct cholangioscopic examination of the common bile duct, Choledocholithiasis, Cholangiocarcinoma, Benign stricture of common bile duct