Clinical trial NCT03525067: Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies
Official title: Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Sepsis
Bile Duct Cancer
Duodenal Cancer
Bile Duct; Obliteration
Post-Op Complication
Post-Op Infection
Fistula, Biliary
Fistula
Delayed Gastric Emptying
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over the age of 18, patients underwent programmed pancreaticoduodenectomy for periampullary neoplasms, involving pancreas head adenocarcinoma, malignant ampulloma and intra papillary and mucinous neoplasm

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative infectious complications at postoperative day 90
timeFrame: Postoperative time until day 90
Secondary outcomes:
measure: Mortality before ICU discharge
timeFrame: 90 days
measure: Mortality post operative day 28
timeFrame: 28 days
measure: Mortality post operative day 90
timeFrame: 90 days
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
state: Grand Est
Study officials:
affiliation: CHRU Nancy
name: Jean Pierre Pertek, MD
role: STUDY_DIRECTOR
References: