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WithdrawnNCT02543957Updated Jan 14, 2021

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

An observational study in Cholangitis and Bacteremia, sponsored by Baylor College of Medicine. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-14.

Sponsored by Baylor College of Medicine · Observational

Why this study was withdrawn
Funding not received.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 80 Years
Sex
All
01

Study 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. The removal of all stones from the participants bile duct (if present).
  2. Acquiring a tissue sample biopsy from any common bile mass to examine (if present).
  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.
Read the detailed description

ERCP with cholangioscopy is becoming a widespread technique to treat complicated choledocholithiasis, document CBD clearance after stone extraction and to assess biliary duct strictures. During the procedure, a large amount of water is used to irrigate the common bile duct in order to improve visualization. This can result in CBD distension and may increase the possibility of bacterial translocation and subsequent bacteremia or septicemia. According to the ASGE guidelines, antibiotic prophylaxis prior to ERCP is indicated when biliary duct obstruction is suspected prior to ERCP procedures . There are no current guidelines addressing antibiotics prophylaxis prior to ERCP with cholangioscopy. The investigators recent ACG funded prospective trial examining the risk of bacteremia in ERCP with cholangioscopy have shown the presence of bacteremia in 8.8% of patients undergoing ERCP with cholangioscopy, thus prompting the use of prophylactic antibiotics in patients undergoing these procedures. However the study was not powered to examine factors associated with increased bacteremia and infectious complications. In spite of the use of pre-procedural antibiotics in some of the published series, infectious complications such as cholangitis and sepsis were still reported after the procedure. In the landmark study by Chen et al, in which 297 patients prospectively underwent single-operator cholangioscopy in 15 referral centers across the US and Europe, nine patients developed cholangitis. Antibiotics administration prior to the procedures was left to the standard of practice at each participating institution and was not reported in this study. In a retrospective study by Kalaitzakis et al, nine out of 179 patients who underwent cholangioscopy for CBD stricture or treatment of CBD stones developed cholangitis. Cholangitis was fatal in one case and required prolonged hospitalization in the other case. All patients in this study had antibiotics prophylaxis prior to the procedure. Manta et al had one case of cholangitis in their series of 52 patients who underwent cholangioscopy for CBD stricture. Two patients out of 87 patients had cholangitis in the study by Osania et al., which prospectively included patients who underwent cholangioscopy for CBD stricture. The cholangitis rate in the previously mentioned studies ranged from 2% to 5%. This high rate of post procedure cholangitis in spite of the use of pre-procedural antibiotics suggest that post procedure antibiotics are of value in subsets of patients who will undergo ERCP with cholangioscopy. In the investigators preliminary data, bacteremia rate was significantly higher in patients with CBD strictures who had cholangioscopy with biopsies. It is possible that strictures could lead to colonization of biliary epithelium with bacteria. Obtaining biopsies may cause disruption of the endothelial barrier allowing bacterial translocation. In addition, cholangitis was seen in one patient in the investigators cohort who underwent laser lithotripsy for large stone. Choledocholithiasis is another source of bacterial colonization which could increase the risk of cholangitis after ERCP and cholangioscopy. The investigators protocol objective is to examine the factors that are potentially associated with increased frequency of bacteremia and subsequent infectious complication after ERCP with cholangioscopy in a setting of uniform pre-procedure antibiotics. The investigators hypothesize that biopsy of CBD strictures and Laser Lithotripsy are risk factors for increased rate of bacteremia and infectious complications after ERCP with cholangioscopy.

02

Conditions studied

  • Cholangitis
  • Bacteremia

Keywords

  • ERCP
  • Cholangitis
  • Bacteremia
  • Antibiotics
03

In context

Bacteremia

322 studies on the registry are indexed under Bacteremia; 49 are open to participants now.

Browse Bacteremia studies →

Lead sponsor

Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Interventions

  • ProcedureCholangioscopy

    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.

06

What researchers measure

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.

    Time frame: 7 days

Secondary outcomes

  1. Examine the incidence of bacteremia in patients undergoing ERCP with cholangioscopy

    Existing prospective data have shown bacteremia in 8.8% of patients undergoing ERCP with cholangioscopy, thus promoting the use of prophylactic antibiotics in patients undergoing these procedures. Three blood withdrawals from the patient undergoing ERCP with Cholangioscopy. One blood withdrawal will be taken before the procedure (Cholangioscopy), the second one will be taken 5 minutes after the procedure and the last blood withdrawal will be taken 30 minutes after the procedure with an overall 30 cc blood withdrawn from each patient. Aseptic techniques will be taken to minimize the contamination of the blood sample by the skin flora. Patients with positive blood culture for bacteremia will be monitored and only patients with fever and evidence of sepsis or cholangitis will be treated with antibiotics. The patient will receive a phone questionnaire about adverse affects that might have happened after the procedure 24 hours after the procedure and 1 week after the procedure.

    Time frame: 7 days

07

Study locations

1 site
  • Baylor College of Medicine
    Houston, Texas 77030, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02543957
Lead sponsor
Baylor College of Medicine
Responsible party
Mohamed Othman (M.D. Director of Advanced Endoscopy Assistant Professor of Medicine - Gastroenterology Section, Baylor College of Medicine) — Principal investigator
First posted
Sep 9, 2015
Start date
Sep 2015
Primary completion
Sep 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Jan 14, 2021

Study contacts

Mohamed Othman, MD
principal investigator · Baylor College of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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