pCAS study

Phase 3

Recruiting

• Conditions: Diseases which require high-level HBP surgeries; Candida

• Registration Number: JPRN-jRCTs041200022
• Lead Sponsor: Shugo Mizuno

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparisons of SSIs incidence between candida eradication group and non-eradication group.

Secondary Outcome Measures

Name	Time	Method
1) Early postoperative complications (Clavien-Dindo classification >/= IIIa) (within 14 days after operation)<br>2) Late postoperative complications (between 15 and 90 days afer operation)<br>3) 90-day mortality<br>4) Eradication rate of Candida species using amphotericin B<br>5) Investigations of bacterial and fungal species detected in oral and rectal cavity, gastric juice, bile and SSIs<br>6) Relation between the amount of fungi and the incidence of SSIs<br>7) Risk factors of oral and rectal candida colonization