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

Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673269
• Other study ID #: E12053-A
• Status: Completed
• Phase: N/A
• First received: August 22, 2012
• Last updated: May 15, 2017
• Start date: July 2012
• Est. completion date: October 2013

Study information

• Verified date: May 2017
• Source: Texas Tech University Health Sciences Center, El Paso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacteremia
• Benign Stricture of Common Bile Duct
• Cholangiocarcinoma
• Choledocholithiasis
• Constriction, Pathologic

Intervention

Other:
• Blood culture ( aerobic and anaerobic)
Blood culture 5 minutes and 30 minutes after the procedure

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center at El Paso	El Paso	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center, El Paso	American College of Gastroenterology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.