Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies

Completed

• Conditions: Pancreatic Cancer; Sepsis; Post-Op Complication; Fistula; Post-Op Infection; Duodenal Cancer; Bile Duct; Obliteration; Fistula, Biliary; Delayed Gastric Emptying; Bile Duct Cancer
• Interventions: Other: Bile sampling for bacterial examination

• Registration Number: NCT03525067
• Lead Sponsor: Central Hospital, Nancy, France

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.

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2018-02-01
• Study Completion: 2018-04-02
• Study First Submitted: 2018-04-26
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-14
• Last Update Submitted: 2018-05-14
• Study First Posted: 2018-05-15
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Bile Samples	Bile sampling for bacterial examination	Patients underwent pancreaticoduodenectomy who had intraoperative bile sampling for bacterial examination.

Primary Outcome Measures

Name	Time	Method
Postoperative infectious complications at postoperative day 90	Postoperative time until day 90	Patients with postoperative infectious complications and compare bacteriological results of samples with bile samples.

Secondary Outcome Measures

Name	Time	Method
Mortality before ICU discharge	90 days	Mortality rate before ICU discharge
Mortality post operative day 28	28 days	Mortality rate at post operative day 28
Mortality post operative day 90	90 days	Mortality rate at post operative day 90

Trial Locations

Locations (1)

CHRU Nancy; 🇫🇷 Nancy, Grand Est, France