Clinical trial NCT01673269: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
Collaborators: name: American College of Gastroenterology
First posted: 2012-08-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: the frequency of bacteremia after ERCP with direct cholangioscopic examination of the CBD
timeFrame: 5 minutes and 30 minutes
Secondary outcomes:
measure: To measure the frequency of fever or sepsis after ERCP with direct cholangioscopic examination of the CBD
timeFrame: within 24 hours and one week of the procedures.
Other outcomes:
Locations:
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center at El Paso
state: Texas
Study officials:
affiliation: Texas Tech University at El Paso
name: Mohamed O Othman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.