UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018705 |
|---|---|
| Receipt number | R000021509 |
| Scientific Title | Goal-Directed Therapy in esophagectomy |
| Date of disclosure of the study information | 2015/08/18 |
| Last modified on | 2022/03/01 16:40:58 |
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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
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
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
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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 30 | Day |
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
| 2022 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021509
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
