NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041200022

Registered date:24/06/2020

pCAS study

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedDiseases which require high-level HBP surgeries
Date of first enrollment19/11/2020
Target sample size260
Countries of recruitment
Study typeInterventional
Intervention(s)Patients, who are classified into candida eradication group, recieve amphotericin B 100mg after every meals and at bedtime (4 times) for 12 days before operation.

Outcome(s)

Primary OutcomeComparisons of SSIs incidence between candida eradication group and non-eradication group.
Secondary Outcome1) 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

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 90age old
GenderBoth
Include criteriaPatients who undergo high-level hepatobiliary pancreatic surgeries defined by Japanese Society of Hepato- Biliary-Pancreatic Surgery
Exclude criteria1) 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.

Related Information

Contact

Public contact
Name Takuya Yuge
Address 2-174 Edobashi Mie Japan 514-0001
Telephone +81-59-232-1111
E-mail yuget@med.mie-u.ac.jp
Affiliation Department of Hepatobiliary Pancreatic and Transplant Surgery, Mie University School of Medicine
Scientific contact
Name Mizuno Shugo
Address 2-174 Edobashi, Tsu city, Mie, Japan Mie Japan 514-0001
Telephone +81-59-232-1111
E-mail mizunos@clin.medic.mie-u.ac.jp
Affiliation Department of Hepatobiliary Pancreatic and Transplant Surgery, Mie University School of Medicine