Colonization of Bile Ducts & Infectious Complications in Cephalic

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04555252
Study type	Observational
Source	Central Hospital, Nancy, France
Contact
Status	Completed
Phase
Start date	February 1, 2020
Completion date	May 31, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Colonization of Bile Ducts and Infectious Complications in Cephalic Duodenopancreatectomy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms