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Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies

Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03525067
Enrollment
46
Registered
2018-05-15
Start date
2017-02-01
Completion date
2018-04-02
Last updated
2018-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERBile 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.

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative infectious complications at postoperative day 90Postoperative time until day 90Patients with postoperative infectious complications and compare bacteriological results of samples with bile samples.

Secondary

MeasureTime frameDescription
Mortality before ICU discharge90 daysMortality rate before ICU discharge
Mortality post operative day 2828 daysMortality rate at post operative day 28
Mortality post operative day 9090 daysMortality rate at post operative day 90

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026