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NCT Number: NCT03525067

Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies

The aim of the present prospective study was, first, to verify the correlation between biliary colonization and postoperative infectious complications, and secondarily to asses morbidity and mortality for patients who underwent pancreaticoduodenectomy.

The hypothesis is that a proportion of post-operative infections after pancreaticoduodenectomy is due to bacteria that colonize the bile ducts during the preoperative period.

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Key information

Conditions

Pancreatic Cancer Bile Duct Cancer Bile Duct Diseases Bile Duct Neoplasms Bile Duct; Obliteration Biliary Fistula Biliary Tract Diseases Biliary Tract Neoplasms Delayed Gastric Emptying Digestive System Diseases Digestive System Fistula Digestive System Neoplasms Duodenal Cancer Duodenal Diseases Duodenal Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Fistula Fistula, Biliary Gastrointestinal Diseases Gastrointestinal Neoplasms Gastroparesis Infections Inflammation Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pancreatic Diseases Pancreatic Neoplasms Paralysis Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Post-Op Complication Post-Op Infection Postoperative Complications Sepsis Signs and Symptoms Stomach Diseases Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Nancy

Nancy, Grand Est, 54035, France

About this study

Pancreaticoduodenectomy is part of the curative treatment of periampullary neoplasms. Postoperative mortality for this procedure is between 1 and 5 %, and morbidity ranging from 30 to 50%. Infectious complications, with pancreatic fistula and gastric delayed empting, are an important part of this morbidity, affecting nearly 35% of patients.

One of the risk factors of infectious complications is the presence of a preoperative obstructive jaundice, due to obstruction of bile ducts by the tumor. In this case, it is proposed to perform a preoperative drainage of the bile ducts, preferably by endoscopic procedure (ERCP), associated with the placement of a endoprosthesis. However, this procedure is controversial, this one increasing postoperative morbidity, and in particular the rate of infectious complications. One explanation of these events is the bacteriological contamination of the bile ducts during the endoscopic procedure. In addition, it has been observed for the patients who have benefited from preoperative drainage, the biliary flora is predominantly polymicrobial and may contain multiresistant nosocomial germs, unlike patients who have not benefited from this procedure, whose biliary flora is predominantly sterile or monomicrobial. This colonization by multiresistant germs may have consequences in the postoperative period, in fact, up to 49% of the germs found in the bile samples are also found in the samples taken during postoperative infectious events. This microbial release could make it more difficult to take care of postoperative infections, with less efficacy of conventional antibiotic treatments.

The aim of the present prospective study was, first, to verify the correlation between biliary colonization and postoperative infectious complications, and secondarily to asses morbidity and mortality in patients who underwent pancreaticoduodenectomy. Patients whit colonized bile and patients with sterile bile were compared for these outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients over the age of 18
  • patients underwent programmed pancreaticoduodenectomy

Exclusion criteria

  • Patients underwent emergency pancreaticoduodenectomy (delay less than 48 hours)
  • Patients had not been taken of a biliary sample in intraoperative period

Treatment and study plan

Bile sampling for bacterial examination

Other

At the beginning of pancreaticoduodenectomy, patients had bile sampling from the gallbladder or from the common bile duct for bacterial examination and study of susceptibility to antibiotics.

Primary outcomes

  1. Postoperative infectious complications at postoperative day 90

    Time frame: Postoperative time until day 90

    Patients with postoperative infectious complications and compare bacteriological results of samples with bile samples.

Secondary outcomes

  1. Mortality before ICU discharge

    Time frame: 90 days

    Mortality rate before ICU discharge

  2. Mortality post operative day 28

    Time frame: 28 days

    Mortality rate at post operative day 28

  3. Mortality post operative day 90

    Time frame: 90 days

    Mortality rate at post operative day 90

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 15, 2018
Registry last updated
May 15, 2018

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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