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NCT Number: NCT04555252

Colonization of Bile Ducts and Infectious Complications in Cephalic Duodenopancreatectomy

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.

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Key information

Conditions

Infection, Bacterial Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chru Nancy

Vandœuvre-lès-Nancy, 54511, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Non infectious surgical complications using scores

    Time frame: from date of surgery up to 30 postoperative days

    Clavien-Dindo Classification, SOFA score

  4. 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

  5. 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

  6. length of stay in intensive care and hospital

    Time frame: During the ICU stay and hospital

    Number of days in ICU and hospital

  7. mortality rate

    Time frame: At day +28 and day +90

    number of death at 28 days and 90 days

  8. 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

  9. Nutritional status measured by nutritional risk index (NRI)

    Time frame: preoperative

    Body mass index (BMI) and albuminemia computation

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 18, 2020
Registry last updated
Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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