pCAS study

JRCT ID: jRCTs041200022

Registered date:24/06/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diseases which require high-level HBP surgeries
• Date of first enrollment: 19/11/2020
• Target sample size: 260
• Study type: Interventional
• 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 Outcome: Comparisons of SSIs incidence between candida eradication group and non-eradication group.

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

Patients who undergo high-level hepatobiliary pancreatic surgeries defined by Japanese Society of Hepato-
Biliary-Pancreatic Surgery

Exclude 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.

Related Information

• Primary Sponsor: Shugo Mizuno