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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01673269

Enrollment

Registered

2012-08-27

Start date

2012-07-31

Completion date

2013-10-31

Last updated

2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Stricture of Common Bile Duct, Cholangiocarcinoma, Choledocholithiasis

Keywords

ERCP, Direct cholangioscopic examination of the common bile duct, Choledocholithiasis, Cholangiocarcinoma, Benign stricture of common bile duct

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.

Interventions

OTHERBlood culture ( aerobic and anaerobic)

Blood culture 5 minutes and 30 minutes after the procedure

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026