Colonization of Bile Ducts and Infectious Complications in Cephalic Duodenopancreatectomy

July 9, 2021 updated by: Central Hospital, Nancy, France

Colonization of Bile Ducts and Post-operative Infectious Complications of Cephalic Duodenopancreatectomy : A Prospective Observational Study

Cephalic duodenopancreatectomy is part of the curative treatment for pancreatic cancer of the head and peri-ampullary area. The mortality of the procedure is around 5%, with a morbidity ranging from 30 to 50%. Infectious complications account for 35% of overall morbidity.

One of the risk factors for postoperative complications is the existence of preoperative retentional jaundice, due to tumoral obstruction of the main bile duct In these cases, it is proposed to perform preoperative bile duct drainage, preferably by endoscopic stenting (ERCP).

However, several studies have shown these procedures to cause biliary contamination which could be responsible for an increase in post-operative morbidity such as infectious complications and increased length of stay in hospital..

Thus, the biliary microbial flora is more often multi-microbial and may contain multidrug-resistant nosocomial germs,

The study carried out by Cortes et al., based on a control case study design, also showed that a correlation between biliary colonization and postoperative infectious complications existed in patients who benefited from a preoperative biliary drainage technique. In fact, the bacteria isolated during intraoperative bile sampling were similar, in 49% of cases, to those isolated during bacteriological samples collected postoperatively during infectious complications.

The work carried out by Krüger and al has shown that the spectrum of bacteria found in the preoperative bile samples from patients who have undergone bile duct dilation is potentially not covered by standard antibiotic therapy.

The aim of this observational prospective study is to investigate this correlation between biliary colonization and postoperative infectious complications, to evaluate the morbidity and postoperative mortality of cephalic duodenopancreatectomies performed at the CHRU of Nancy and to study a possible adaptation of perioperative antibiotic prophylaxis.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandœuvre-lès-Nancy, France, 54511
        • CHRU Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will be offered to the patient who has benefited from a cephalic duodenopancreatectomy programmed and hospitalized in CHRU Nancy's ICU

Description

Inclusion Criteria:

  • Age > 18 years
  • Patient operated for a planned cephalic duodenopancreatectomy
  • Post-operative hospitalisation in ICU
  • Information leaflet given to the patient and the support person, with oral information, during the post-operative period

Exclusion Criteria:

  • Age < 18 years
  • Emergency duodenopancreatectomy (surgical indication period less than 48 hours)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Cephalic Duodenopancreatectomy
Patients who underwent scheduled cephalic duodenopancreatectomy and hospitalized in intensive care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of preoperative Bile and postoperative infection sites microbiology results
Time Frame: from date of initial bile sample up to 30 days of postoperative period
bacterial count in log10 bacteria/ml and identification
from date of initial bile sample up to 30 days of postoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of prior biliary drainage on the intraoperative bile microbiological results bacteriological results obtained
Time Frame: from date of initial bile sampling to date of surgery (up to 90 days)
bacterial count in log10 bacteria/ml and species identification
from date of initial bile sampling to date of surgery (up to 90 days)
Microbial flora in clinical specimens obtained from different sites
Time Frame: from date of initial bile sample up to 90 postoperative days
bacterial count in log10 bacteria/ml and species identification
from date of initial bile sample up to 90 postoperative days
Non infectious surgical complications using scores
Time Frame: from date of surgery up to 30 postoperative days
Clavien-Dindo Classification, SOFA score
from date of surgery up to 30 postoperative days
postoperative infectious complications as defined by the Centers for Disease Control and Prevention (Atlanta, Ga)
Time Frame: During hospital stay (up to 90 days after surgery)
number of event occurence
During hospital stay (up to 90 days after surgery)
Implication of bacteria found in biliculture as causative agent in post-operative infections
Time Frame: During hospital stay (up to 90 days after surg
incidence in percentage
During hospital stay (up to 90 days after surg
length of stay in intensive care and hospital
Time Frame: During the ICU stay and hospital
Number of days in ICU and hospital
During the ICU stay and hospital
mortality rate
Time Frame: At day +28 and day +90
number of death at 28 days and 90 days
At day +28 and day +90
Description of nutrition assistance
Time Frame: from date of initial bile sample up to 30 days of postoperative period
Parenteral, enteral, oral feeding in days and calories
from date of initial bile sample up to 30 days of postoperative period
Nutritional status measured by nutritional risk index (NRI)
Time Frame: preoperative
Body mass index (BMI) and albuminemia computation
preoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: MARIE-REINE LOSSER, MD,PhD, CHRU Nancy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

March 28, 2021

Study Completion (Actual)

May 31, 2021

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

September 14, 2020

First Posted (Actual)

September 18, 2020

Study Record Updates

Last Update Posted (Actual)

July 12, 2021

Last Update Submitted That Met QC Criteria

July 9, 2021

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRU NANCY : 2019PI249

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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