UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033085 |
|---|---|
| Receipt number | R000037725 |
| Scientific Title | Clinical validation of indcyanine-green(ICG) fluorescence making in endoscopic esophagus/gastric cancer surgery. |
| Date of disclosure of the study information | 2018/06/21 |
| Last modified on | 2018/06/21 18:02:19 |
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Basic information
Public title
Clinical validation of indcyanine-green(ICG) fluorescence making in endoscopic esophagus/gastric cancer surgery.
Acronym
validation of ICG making in laparoscopic esophagus/gastric cancer surgery.
Scientific Title
Clinical validation of indcyanine-green(ICG) fluorescence making in endoscopic esophagus/gastric cancer surgery.
Scientific Title:Acronym
validation of ICG making in laparoscopic esophagus/gastric cancer surgery.
Region
| Japan |
Condition
Condition
esophageal cancer and gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate for the usefulness and safety of ICG fluorescence method identifying tumor localization.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tumor identification rate by ICG marking method
Key secondary outcomes
Safety (allergic reaction, incidence of perioperative complications)
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
indocyanine green
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
Initial esophageal cancer or gastric cancer case
Key exclusion criteria
1) Cases with severe ischemic heart disease
2) Cases with complications of liver cirrhosis and active hepatitis
3) Cases with dyspnea requiring oxygen administration
4) Cases in which dialysis is performed in chronic renal failure
5) Cases requiring complication of other organs
6) Other cases that the physician judged as inappropriate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Nobuoka |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
Address
South-1, West-16, Chuo-ku Sapporo, Japan
TEL
011-611-2111
tnobu@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Nobuoka |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
Address
South-1, West-16, Chuo-ku Sapporo, Japan
TEL
011-611-2111
Homepage URL
tnobu@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 06 | Month | 21 | 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
| 2018 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 08 | 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
| 2018 | Year | 06 | Month | 21 | Day |
Last modified on
| 2018 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037725
