UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028516
Receipt number R000032431
Scientific Title Evaluation of anastomotic blood flow after rectal resection using the ICG fluorescence method
Date of disclosure of the study information 2017/09/01
Last modified on 2020/08/10 20:05:05

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Basic information

Public title

Evaluation of anastomotic blood flow after rectal resection using the ICG fluorescence method

Acronym

Evaluation of anastomotic blood flow after rectal resection using the ICG fluorescence method

Scientific Title

Evaluation of anastomotic blood flow after rectal resection using the ICG fluorescence method

Scientific Title:Acronym

Evaluation of anastomotic blood flow after rectal resection using the ICG fluorescence method

Region

Japan


Condition

Condition

rectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of anastomotic blood flow after rectal resection using the ICG fluorescence method

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of anastomotic blood flow using the ICG fluorescence method

Key secondary outcomes

1 Incidence rate of side effect
2 Incidence rate of anastomotic leakage


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 injection at the rectal surgery

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

1 Scheduled for elective surgery for a rectal cancer
2 Age>=20
3 Written informed consent

Key exclusion criteria

1 Allergic hypersensitivity of the indocyanine green
2 Allergic hypersensitivity of the iodine

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yoshiaki
Middle name
Last name Kuriu

Organization

Kyoto Prefectural University of Medicine

Division name

Division of Digestive Surgery

Zip code

602-8566

Address

465 Kajii-cho, Kamigyo-ku, Kyoto city

TEL

075-251-5527

Email

kuriu@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Yoshiaki
Middle name
Last name Kuriu

Organization

Kyoto Prefectural University of Medicine

Division name

Division of Digestive Surgery

Zip code

602-8566

Address

465 Kajii-cho, Kamigyo-ku, Kyoto city

TEL

075-251-5527

Homepage URL


Email

kuriu@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

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 Prefectural University of Medicine

Address

465 Kajii-cho, Kamigyo-ku, Kyoto sity

Tel

+81-75-251-5527

Email

kuriu@koto.kpu-m.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

2017 Year 09 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

Open public recruiting

Date of protocol fixation

2017 Year 09 Month 01 Day

Date of IRB

2017 Year 11 Month 01 Day

Anticipated trial start date

2017 Year 10 Month 01 Day

Last follow-up date

2020 Year 12 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

2017 Year 08 Month 03 Day

Last modified on

2020 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032431


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name