UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047931 |
|---|---|
| Receipt number | R000054642 |
| Scientific Title | Surgical procedure using intraoperative navigation with ICG (indocyanine green) in gastrointestinal cancer |
| Date of disclosure of the study information | 2022/06/03 |
| Last modified on | 2022/06/02 18:16:24 |
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Basic information
Public title
Surgical procedure using intraoperative navigation with ICG (indocyanine green) in gastrointestinal cancer
Acronym
Surgical procedure using intraoperative navigation with ICG (indocyanine green) in gastrointestinal cancer
Scientific Title
Surgical procedure using intraoperative navigation with ICG (indocyanine green) in gastrointestinal cancer
Scientific Title:Acronym
Surgical procedure using intraoperative navigation with ICG (indocyanine green) in gastrointestinal cancer
Region
| Japan |
Condition
Condition
Esophageal cancer, gastric cancer, duodenal cancer, Biliary tract cancer, pancreatic cancer, colon cancer
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish a surgical technique incorporating the ICG fluorescence method in gastrointestinal cancer surgery to improve the surgical results and prognosis of gastrointestinal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of fluorescence images useful for determining the extent of excision
Key secondary outcomes
Percentage of fluorescent images of lymphatic flow from the serosa of the organ to the base of the artery along the area of the dominant artery
Negative margin rate in resected specimens
Long-term results (relapse-free survival, overall survival)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Submucosal and subserosal injections of the ICG gastrointestinal tract
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
Gastrointestinal cancer patients (esophageal cancer, gastric cancer, duodenal cancer, biliary tract cancer, pancreatic cancer, and colorectal cancer) surgery undergoing elective surgery at our university
Key exclusion criteria
Patients with a history of hypersensitivity to ICG components
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Sang-Woong |
| Middle name | |
| Last name | Lee |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of General and Gastroenterological Surgery
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki city, Osaka, Japan
TEL
072-683-1221
sang-woong.lee@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Tanaka |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of General and Gastroenterological Surgery
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki city, Osaka, Japan
TEL
072-683-1221
Homepage URL
ryo.tanaka@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University,
Department of General and Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University,
Department of General and Gastroenterological Surgery
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
Osaka Medical and Pharmaceutical University
Address
2-7 Daigaku-machi, Takatsuki city, Osaka, Japan
Tel
072-6883-1221
rinri@ompu.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
| 2022 | Year | 06 | Month | 03 | 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 | 04 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | 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
| 2022 | Year | 06 | Month | 02 | Day |
Last modified on
| 2022 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054642
