UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030978
Receipt number R000035373
Scientific Title Study of Indocyanine green for gastrectomy
Date of disclosure of the study information 2018/03/01
Last modified on 2018/08/07 22:41:45

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Basic information

Public title

Study of Indocyanine green for gastrectomy

Acronym

Study of Indocyanine green for gastrectomy

Scientific Title

Study of Indocyanine green for gastrectomy

Scientific Title:Acronym

Study of Indocyanine green for gastrectomy

Region

Japan


Condition

Condition

gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Several factors such as lymphatic flow, blood supply, and so on are assessed by using indocyanine green during gastrectomy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Assessment of Assessment of several factors such as lymphatic flow, blood supply, and so on.

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

Other

Interventions/Control_1

Indocyanine green is given to the patients who will undergo gastrectomy on operation day or preopratively

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patitent who undergo robotic or laparscopic gastrectomy are enrolled.
Each patient is assessed whether Indocyanine green is required or not preoperatively.

Key exclusion criteria

Exclusion criteria are as follows.
1) Patients who are pregnant or breastfeeding.
2) Patients who have psychiatric problems and, are regarded difficult to participate the study.
3) Patients who are allergic to iodine.
4) Patients who are in unstable condition and regarded difficult to participate the study.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuyuki Kojima

Organization

Tokyo Medical and Dental University

Division name

Center for Minimally Invasive Surgery

Zip code


Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-5803-5260

Email

k-kojima.srg2@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masatoshi Nakagawa

Organization

Tokyo Medical and Dental University

Division name

Department of Gastric Surgery

Zip code


Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-5803-5254

Homepage URL


Email

nakagawa.srg1@tmd.ac.jp


Sponsor or person

Institute

Department of Gastric Surgery, Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Department of Gastric Surgery, Tokyo Medical and Dental 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


Address


Tel


Email



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 03 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

2018 Year 01 Month 24 Day

Date of IRB


Anticipated trial start date

2018 Year 08 Month 09 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 24 Day

Last modified on

2018 Year 08 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035373


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name