UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007621 |
|---|---|
| Receipt number | R000008997 |
| Scientific Title | Evaluation of blood supply for reconstructed gastric tube using fluorescence method PDE during esophagectomy |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2024/10/08 14:54:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of blood supply for reconstructed gastric tube using fluorescence method PDE during esophagectomy
Acronym
Evaluation of blood supply for reconstructed gastric tube using fluorescence method PDE
Scientific Title
Evaluation of blood supply for reconstructed gastric tube using fluorescence method PDE during esophagectomy
Scientific Title:Acronym
Evaluation of blood supply for reconstructed gastric tube using fluorescence method PDE
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the blood supply of the reconstructed gastric tube during esophagectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Assessment of the time to contrast the feeding vessels of reconstracted gastric tube using indocyanine green fluorescence
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
intravenous injection of indocyanine green during esophagectomy
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
| 10 | years-old | < |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients who undergo gastric tube reconstruction after esophagectomy
Key exclusion criteria
Patients who have the history of side effect using indocyanine green
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Youichi |
| Middle name | |
| Last name | Kumagai |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Digestive tract and General Surgery
Zip code
350-8550
Address
1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, Japan
TEL
0367507317
kuma7srg1@gmail.com
Public contact
Name of contact person
| 1st name | Youichi |
| Middle name | |
| Last name | Kumagai |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Digestive tract and General Surgery
Zip code
3508550
Address
1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, Japan
TEL
049-228-3619
Homepage URL
kuma7srg1@gmail.com
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical University
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
Saitama Medical University
Address
1981 Kamoda, Kawagoeshi Saitama Japan
Tel
0492283619
kuma7srg1@gmail.com
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
埼玉医科大学総合医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2026 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2026 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2026 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 30 | Day |
Last modified on
| 2024 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008997
