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pCAS study

Preoperative eradication of Candida colonization using amphotericin B for surgical site infections after high -level HBP surgeries: A phase III randomized parallel-group trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041200022
Enrollment
260
Registered
2020-06-24
Start date
2020-11-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diseases which require high-level HBP surgeries Candida

Interventions

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.
Candida eradication

Sponsors

Shugo Mizuno
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Comparisons of SSIs incidence between candida eradication group and non-eradication group.

Secondary

MeasureTime 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

Public ContactKazuyuki Gyoten

Department of Hepatobiliary Pancreatic and Transplant Surgery, Mie University School of Medicine

yuget@med.mie-u.ac.jp+81-59-232-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026