Diseases which require high-level HBP surgeries Candida
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients who undergo high-level hepatobiliary pancreatic surgeries defined by Japanese Society of Hepato- Biliary-Pancreatic Surgery
Exclusion criteria
Exclusion criteria: 1) Patients who are allegic to Amphotericin B 2) Patients who have severe infectious diseases including deep mycotic infection 3) Women who are pregnant, possibly pregnant or breast-feeding 4) Patients who have multidrug-resistant bacteria or need medical treatments for bacteria in preoperative oral culture 5) Patients who receive antifungal treatment 6) Patients who are defined as inapproriate to be enrolled in the clinical trial by a principal investigator or subinvestigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparisons of SSIs incidence between candida eradication group and non-eradication group. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Early postoperative complications (Clavien-Dindo classification >/= IIIa) (within 14 days after operation) 2) Late postoperative complications (between 15 and 90 days afer operation) 3) 90-day mortality 4) Eradication rate of Candida species using amphotericin B 5) Investigations of bacterial and fungal species detected in oral and rectal cavity, gastric juice, bile and SSIs 6) Relation between the amount of fungi and the incidence of SSIs 7) Risk factors of oral and rectal candida colonization | — |
Contacts
Department of Hepatobiliary Pancreatic and Transplant Surgery, Mie University School of Medicine