UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038840
Receipt number R000044294
Scientific Title A cost-effective analysis of intraoperative goal-directed therapy for patients undergoing esophagectomy
Date of disclosure of the study information 2019/12/11
Last modified on 2019/12/10 15:20:41

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Basic information

Public title

A cost-effective analysis of intraoperative goal-directed therapy for patients undergoing esophagectomy

Acronym

A cost-effective analysis of intraoperative goal-directed therapy for patients undergoing esophagectomy

Scientific Title

A cost-effective analysis of intraoperative goal-directed therapy for patients undergoing esophagectomy

Scientific Title:Acronym

A cost-effective analysis of intraoperative goal-directed therapy for patients undergoing esophagectomy

Region

Japan


Condition

Condition

Esophageal Cancer

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the cost effectiveness of intraoperative goal-directed therapy in patients undergoing esophagectomy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Medical costs in the perioperative period

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

The treatment group patients are intraoperatively managed using GDT protocol.

Interventions/Control_2

The control group patients are managed with usual anesthetic care.

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 included in the previous study (UMIN000018705)

Key exclusion criteria

1. Atrial fibrillation
2. NYHA classification III or IV
3. Hugh-Jones classification III or IV
4. Coagulation disorder
5. Liver dysfunction
6. Renal dysfunction
7. Patients requiring extended surgical procedures (e.g. requiring free jejunum reconstruction with vascular anastomosis)

Target sample size

240


Research contact person

Name of lead principal investigator

1st name Koichi
Middle name
Last name Suehiro

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Anesthesiology

Zip code

545-8586

Address

1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan

TEL

06-6645-2186

Email

suehirokoichi@yahoo.co.jp


Public contact

Name of contact person

1st name Koichi
Middle name
Last name Suehiro

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Anesthesiology

Zip code

545-8586

Address

1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan

TEL

06-6645-2186

Homepage URL


Email

suehirokoichi@yahoo.co.jp


Sponsor or person

Institute

Department of Anesthesiology, Osaka City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology, Osaka City University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Anesthesiology, Osaka City General Hospital
Department of Anesthesiology, Kansai Denryoku Hospital
Department of Anesthesiology, Sumitomo Hospital
Department of Anesthesiology, JCHO Osaka Hospital
Department of Anesthesiology, Osaka Rosai Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee of Osaka City University Graduate School of Medicine

Address

1-5-7, Asahimachi, Abeno-ku, Osaka 545-8586 Japan

Tel

81-6-6646-6125

Email

ethics@med.osaka-cu.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

2019 Year 12 Month 11 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


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

Preinitiation

Date of protocol fixation

2019 Year 10 Month 01 Day

Date of IRB

2019 Year 10 Month 15 Day

Anticipated trial start date

2019 Year 12 Month 11 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 12 Month 10 Day

Last modified on

2019 Year 12 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044294


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name