UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048860
Receipt number R000055677
Scientific Title Examination of the relationship between candida in gastric juice and infectious complications after hepatectomy
Date of disclosure of the study information 2022/09/05
Last modified on 2022/09/05 20:54:10

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Basic information

Public title

Examination of the relationship between candida in gastric juice and infectious complications after hepatectomy

Acronym

Examination of the relationship between candida in gastric juice and infectious complications after hepatectomy

Scientific Title

Examination of the relationship between candida in gastric juice and infectious complications after hepatectomy

Scientific Title:Acronym

Examination of the relationship between candida in gastric juice and infectious complications after hepatectomy

Region

Japan


Condition

Condition

Hepatectomy cases

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine whether Candida in gastric juice contributes to infectious complications after hepatectomy.

Basic objectives2

Others

Basic objectives -Others

To identify factors that contribute to infectious complications after hepatectomy.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To examine whether Candida in gastric juice contributes to infectious complications after hepatectomy.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients undergoing liver resection

Key exclusion criteria

Patients undergoing simultaneous resection of other organs.
Patients receiving antifungal agents for fungal infection.
Patients after gastrectomy.
Patients undergoing emergency surgery.
Patient lack of written informed consent.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Hiroya
Middle name
Last name Iida

Organization

Shiga University of Medical Science

Division name

Surgery

Zip code

520-2192

Address

Seta Tsukinowa-cho, Otsu, Shiga

TEL

077-548-2238

Email

hiroya@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name Hiroya
Middle name
Last name Iida

Organization

Shiga University of Medical Science

Division name

Surgery

Zip code

520-2192

Address

Seta Tsukinowa-cho, Otsu, Shiga

TEL

077-548-2238

Homepage URL


Email

hiroya@belle.shiga-med.ac.jp


Sponsor or person

Institute

Shiga University of Medical Science

Institute

Department

Personal name



Funding Source

Organization

Shiga University of Medical Science

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shiga University of Medical Science

Address

Seta Tsukinowa-cho, Otsu, Shiga

Tel

077-548-3576

Email

hqrec@belle.shiga-med.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2022 Year 09 Month 05 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

100

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2019 Year 07 Month 08 Day

Date of IRB

2019 Year 07 Month 08 Day

Anticipated trial start date

2019 Year 07 Month 08 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

N/A


Management information

Registered date

2022 Year 09 Month 05 Day

Last modified on

2022 Year 09 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055677


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name