Factors Associated With Increased Risk of Bacteremia and Cholangitis in ERCP With Cholangioscopy

NCT02543957 | Withdrawn DMC

• 1 other identifier: H-37346
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

An Endoscopic retrograde cholangio pancreatography (ERCP) with cholangioscopy (endoscope to directly visualize the bile duct ) is a procedure (a small flexible tube that is inserted into the participants mouth to the participants stomach and into the participants liver to visualize the bile duct) that is usually performed in patients for the following purposes :

1. 1.The removal of all stones from the participants bile duct (if present).
2. 2.Acquiring a tissue sample biopsy from any common bile mass to examine (if present).
3. 3.Acquiring tissue sample biopsy from common bile duct narrowing (if present). However this procedure is associated with an increase risk of infection compared with the standard ERCP (ERCP without cholangioscopy). Previous studies have shown that despite the administration of antibiotics prior to these procedures, infection still occurs. This leads to a suspicion that other factors may be the cause in these infections. Factors such as age, race, gender and ethnicity have not been fully explored yet. This study aims to examine these factors in addition to others in patients who are undergoing ERCP with cholangioscopy as part of their routine medical care. This examination will allow us to bring out if any of the above mentioned factors may be involved in the development of an infection after ERCP with cholangioscopy.

Conditions

Cholangitis; Bacteremia

Keywords

ERCP; Cholangitis; Bacteremia; Antibiotics

Outcome Measures

Primary Outcomes (1)

• Examine the Incidence of new onset infectious complications

  1- To examine the incidence and risk factors of new onset infectious complications such as fever, sepsis or cholangitis within one week after ERCP with cholangioscopy.

  7 days

Secondary Outcomes (1)

• Examine the incidence of bacteremia in patients undergoing ERCP with cholangioscopy

  7 days

Interventions

Cholangioscopy PROCEDURE

All patients will receive pre-procedural antibiotics per protocol. A blood culture will be drawn from patients prior to the procedure (before antibiotics administration), 5 minutes after the procedure and 30 minutes after the procedure. Patients will be followed up for 7 days after the procedure for fever and or sepsis.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study participants ages 18-80 will be recruited from patients undergoing an ERCP at the Baylor St Luke Medical center in Houston or at University of Texas Health Science Center at San Antonio. Both practices are university based practice and serve as a tertiary referral center for all complicated EUS and ERCP procedures in eastern Texas. Choledocholithiasis and its complications requiring ERCP are prevalent and represent a large share of this ERCP practice.

You may qualify if:

• Adult patients (18-80) who are undergoing ERCP with cholangioscopy to ensure the clearance of the CBD from stones.
• Adult patients (18-80) who are undergoing ERCP with cholangioscopy for CBD stone removal using laser lithotripsy.
• Adult patients (18-80) who are undergoing ERCP with cholangioscopy for CBD mass.
• Adult patients (18-80) who are undergoing ERCP with cholangioscopy for tissue acquisition from CBD strictures with biopsies.

You may not qualify if:

• Patients younger than 18 yrs old or older than 80 yrs.
• Pregnant patients.
• Patient with ascending cholangitis, pneumonia or urinary tract infection

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cholangitis; Bacteremia

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamed Othman, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Director of Advanced Endoscopy Assistant Professor of Medicine - Gastroenterology Section

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 9, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 14, 2021

Record last verified: 2021-01

Locations

US (1)