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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018705
Receipt No. R000021509
Scientific Title Goal-Directed Therapy in esophagectomy
Date of disclosure of the study information 2015/08/18
Last modified on 2019/03/25

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Basic information
Public title Goal-Directed Therapy in esophagectomy
Acronym Goal-Directed Therapy in esophagectomy
Scientific Title Goal-Directed Therapy in esophagectomy
Scientific Title:Acronym Goal-Directed Therapy in esophagectomy
Region
Japan

Condition
Condition Esophageal Cancer
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of intraoperative Goal-Directed Therapy to improve postoperative outcomes in patients undergoing esophagectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of severe postoperative complications until one month after surgery
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 undergoing esophagectomy
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
Institute Department of Anesthesiology, Osaka City University Graduate School of Medicine
Institute
Department

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
2015 Year 08 Month 18 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 Enrolling by invitation
Date of protocol fixation
2015 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 18 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021509

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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