Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-04-02

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pancreatic Cancer Sepsis Bile Duct Cancer Duodenal Cancer Bile Duct; Obliteration Post-Op Complication Post-Op Infection Fistula, Biliary Fistula Delayed Gastric Emptying

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Bile Samples

Patients underwent pancreaticoduodenectomy who had intraoperative bile sampling for bacterial examination.

Bile sampling for bacterial examination

Intervention Type 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.

Interventions

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Bile sampling for bacterial examination

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No