Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies

Pancreatic Cancer Clinical Trial

Official title:

Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03525067
• Other study ID #: PSS2016/PERTEK/ELR
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: April 2, 2018

Study information

• Verified date: May 2018
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 2, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Cancer
• Bile Duct Neoplasms
• Bile Duct; Obliteration
• Biliary Fistula
• Cholangiocarcinoma
• Delayed Gastric Emptying
• Duodenal Cancer
• Duodenal Neoplasms
• Fistula
• Fistula, Biliary
• Gastroparesis
• Pancreatic Cancer
• Pancreatic Neoplasms
• Post-Op Complication
• Post-Op Infection
• Postoperative Complications
• Sepsis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	CHRU Nancy	Nancy	Grand Est

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative infectious complications at postoperative day 90	Patients with postoperative infectious complications and compare bacteriological results of samples with bile samples.	Postoperative time until day 90
Secondary	Mortality before ICU discharge	Mortality rate before ICU discharge	90 days
Secondary	Mortality post operative day 28	Mortality rate at post operative day 28	28 days
Secondary	Mortality post operative day 90	Mortality rate at post operative day 90	90 days