Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-05 @ 6:12 PM
Study NCT ID:
NCT03525067
Status:
COMPLETED
Last Update Posted:
2018-05-15
First Post:
2018-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies
Sponsor:
Central Hospital, Nancy, France
Organization:
Study Overview
Official Title:
Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies
Status:
COMPLETED
Status Verified Date:
2018-05
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:
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.
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.
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 Oversight
Has Oversight DMC:
False
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?: