Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04555252
Status:
COMPLETED
Last Update Posted:
2021-07-12
First Post:
2020-08-10
Brief Title:
Colonization of Bile Ducts and Infectious Complications in Cephalic Duodenopancreatectomy
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Colonization of Bile Ducts and Post-operative Infectious Complications of Cephalic Duodenopancreatectomy A Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cephalic duodenopancreatectomy is part of the curative treatment for pancreatic cancer of the head and peri-ampullary area The mortality of the procedure is around 5 with a morbidity ranging from 30 to 50 Infectious complications account for 35 of overall morbidity
One of the risk factors for postoperative complications is the existence of preoperative retentional jaundice due to tumoral obstruction of the main bile duct In these cases it is proposed to perform preoperative bile duct drainage preferably by endoscopic stenting ERCP
However several studies have shown these procedures to cause biliary contamination which could be responsible for an increase in post-operative morbidity such as infectious complications and increased length of stay in hospital
Thus the biliary microbial flora is more often multi-microbial and may contain multidrug-resistant nosocomial germs
The study carried out by Cortes et al based on a control case study design also showed that a correlation between biliary colonization and postoperative infectious complications existed in patients who benefited from a preoperative biliary drainage technique In fact the bacteria isolated during intraoperative bile sampling were similar in 49 of cases to those isolated during bacteriological samples collected postoperatively during infectious complications
The work carried out by Krüger and al has shown that the spectrum of bacteria found in the preoperative bile samples from patients who have undergone bile duct dilation is potentially not covered by standard antibiotic therapy
The aim of this observational prospective study is to investigate this correlation between biliary colonization and postoperative infectious complications to evaluate the morbidity and postoperative mortality of cephalic duodenopancreatectomies performed at the CHRU of Nancy and to study a possible adaptation of perioperative antibiotic prophylaxis
One of the risk factors for postoperative complications is the existence of preoperative retentional jaundice due to tumoral obstruction of the main bile duct In these cases it is proposed to perform preoperative bile duct drainage preferably by endoscopic stenting ERCP
However several studies have shown these procedures to cause biliary contamination which could be responsible for an increase in post-operative morbidity such as infectious complications and increased length of stay in hospital
Thus the biliary microbial flora is more often multi-microbial and may contain multidrug-resistant nosocomial germs
The study carried out by Cortes et al based on a control case study design also showed that a correlation between biliary colonization and postoperative infectious complications existed in patients who benefited from a preoperative biliary drainage technique In fact the bacteria isolated during intraoperative bile sampling were similar in 49 of cases to those isolated during bacteriological samples collected postoperatively during infectious complications
The work carried out by Krüger and al has shown that the spectrum of bacteria found in the preoperative bile samples from patients who have undergone bile duct dilation is potentially not covered by standard antibiotic therapy
The aim of this observational prospective study is to investigate this correlation between biliary colonization and postoperative infectious complications to evaluate the morbidity and postoperative mortality of cephalic duodenopancreatectomies performed at the CHRU of Nancy and to study a possible adaptation of perioperative antibiotic prophylaxis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None