UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030906
Receipt number R000035289
Scientific Title Efficacy of lymph flow navigation surgery with infrared ray electronic endoscopy by local injection of Indocyanine Green in gastroenterological cancer
Date of disclosure of the study information 2018/01/22
Last modified on 2023/02/13 12:44:06

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Basic information

Public title

Efficacy of lymph flow navigation surgery with infrared ray electronic endoscopy by local injection of Indocyanine Green in gastroenterological cancer

Acronym

Efficacy of lymph flow navigation surgery with infrared ray electronic endoscopy by local injection of Indocyanine Green in gastroenterological cancer

Scientific Title

Efficacy of lymph flow navigation surgery with infrared ray electronic endoscopy by local injection of Indocyanine Green in gastroenterological cancer

Scientific Title:Acronym

Efficacy of lymph flow navigation surgery with infrared ray electronic endoscopy by local injection of Indocyanine Green in gastroenterological cancer

Region

Japan


Condition

Condition

gastroenterological cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

With infrared ray electronic endoscopy after local injection of indocyanine Green, lymphatic flow and metastatic route in lymph node metastasis were assessed, and the efficacy of this procedure is validated.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

not defined

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

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Indocyanine Green is injected submucosally around the tumor

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

Patients with the diagnosis of esophageal or gastric or colon cancer who will undergo curative surgery.

Key exclusion criteria

Patients who refused to join in this study.
Patients who have allergy to Indocyanine Green.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Kazutaka
Middle name
Last name Obama

Organization

Kyoto University Hospital

Division name

Surgery

Zip code

606-8507

Address

54, Kawahara-cho, Sakyo-ku, Kyoto

TEL

075-366-7595

Email

kobama@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Koya
Middle name
Last name Hida

Organization

Kyoto University Hospital

Division name

Surgery

Zip code

606-8507

Address

54, Kawahara-cho, Sakyo-ku, Kyoto

TEL

075-366-7595

Homepage URL


Email

hidakoya@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Hospital, Department of Surgery

Institute

Department

Personal name



Funding Source

Organization

Kyoto University Hospital, Department of Surgery

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

Kyoto University Certified Review Board

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.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

2018 Year 01 Month 22 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

2018 Year 01 Month 19 Day

Date of IRB


Anticipated trial start date

2018 Year 03 Month 01 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 01 Month 20 Day

Last modified on

2023 Year 02 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035289


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name