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

Not Applicable

Completed

• Conditions: Cholangiocarcinoma; Choledocholithiasis; Benign Stricture of Common Bile Duct
• Interventions: Other: Blood culture ( aerobic and anaerobic)

• Registration Number: NCT01673269
• Lead Sponsor: Texas Tech University Health Sciences Center, El Paso

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-08-22
• Study First Posted: 2012-08-27
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ERCP with direct examination of the CBD	Blood culture ( aerobic and anaerobic)	-

Primary Outcome Measures

Name	Time	Method
the frequency of bacteremia after ERCP with direct cholangioscopic examination of the CBD	5 minutes and 30 minutes	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

Name	Time	Method
To measure the frequency of fever or sepsis after ERCP with direct cholangioscopic examination of the CBD	within 24 hours and one week of the procedures.	This outcome will be obtained by calling the patient 24 hour and 1 week after the procedure

Trial Locations

Locations (1)

Texas Tech University Health Sciences Center at El Paso; 🇺🇸 El Paso, Texas, United States