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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042199
Receipt No. R000046751
Scientific Title Intraoperative Identification of Lymphatic Flow and Evaluation of Lymph Node Metastasis Using Indocyanine Green Fluorescence Imaging for Esophageal Cancer: An Exploratory Clinical Study
Date of disclosure of the study information 2020/11/01
Last modified on 2021/04/22

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Basic information
Public title Intraoperative Identification of Lymphatic Flow and Evaluation of Lymph Node Metastasis Using Indocyanine Green Fluorescence Imaging for Esophageal Cancer: An Exploratory Clinical Study
Acronym Intraoperative Identification of Lymphatic Flow and Evaluation of Lymph Node Metastasis Using Indocyanine Green Fluorescence Imaging for Esophageal Cancer: An Exploratory Clinical Study
Scientific Title Intraoperative Identification of Lymphatic Flow and Evaluation of Lymph Node Metastasis Using Indocyanine Green Fluorescence Imaging for Esophageal Cancer: An Exploratory Clinical Study
Scientific Title:Acronym Intraoperative Identification of Lymphatic Flow and Evaluation of Lymph Node Metastasis Using Indocyanine Green Fluorescence Imaging for Esophageal Cancer: An Exploratory Clinical Study
Region
Japan

Condition
Condition Patients with esophageal cancer who assigned to curative surgical treatment
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To reveal the effect of lymphatic flow identification using indocyanine-green fluorescence imaging(IGFI) on predicting of the extent of lymph node metastasis in esophageal cancer patients
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sensitivity, positive likelihood ratio, negative likelihood ratio, and their confidence interval when ICG staining is used as an index evaluation and Metastasis is used as a reference standard for all dissected lymph node stations.
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 Treatment
Type of intervention
Medicine
Interventions/Control_1 We perform endoscopic submucosal injection of ICG around the primary lesion using a four-quadrant injection pattern with a 23-gauge endoscopic injection sclerotherapy needle.
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
90 years-old >
Gender Male and Female
Key inclusion criteria Esophageal cancer patients who assigned to curative surgical resection
1) 20yrs and older
2) PS(ECOG Performance status) 0 or 1
3) favorable major organ function
Key exclusion criteria 1) past history of ICG or Iodine hypersensitivity
2) pregnant patient
3) breast feeding patient
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Yagi
Organization Tokyo University Hospital
Division name Department of Gastrointestinal Surgery
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email yagik-tky@umin.ac.jp

Public contact
Name of contact person
1st name Shinichiro
Middle name
Last name Shiomi
Organization Tokyo University Hospital
Division name Department of Gastrointestinal Surgery
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email sshiomi-tky@umin.ac.jp

Sponsor
Institute Tokyo University Hospital, Department of Gastrointestinal Surgery
Institute
Department

Funding Source
Organization Tokyo University Hospital
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 Research Ethics Office, Graduate School of Medicine, The University of Tokyo
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel 03-5841-0818
Email ethics@m.u-tokyo.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
2020 Year 11 Month 01 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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 16 Day
Date of IRB
2020 Year 10 Month 15 Day
Anticipated trial start date
2020 Year 11 Month 01 Day
Last follow-up date
2023 Year 03 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
2020 Year 10 Month 21 Day
Last modified on
2021 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046751

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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