UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037361
Receipt number R000042599
Scientific Title Observational study of fluorescence-guided digestive tract surgery
Date of disclosure of the study information 2019/07/13
Last modified on 2020/07/15 21:46:22

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Basic information

Public title

Observational study of fluorescence-guided digestive tract surgery

Acronym

Observational study of fluorescence-guided digestive tract surgery

Scientific Title

Observational study of fluorescence-guided digestive tract surgery

Scientific Title:Acronym

Observational study of fluorescence-guided digestive tract surgery

Region

Japan


Condition

Condition

Digestive cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Blood flow assessment in gastrointestinal surgery became available for insurance in 2008. Certain evidence has also been recognized in the PILLAR II trial, and this area is widely used in the future. However, its usefulness and safety have not been evaluated at present.
In addition, although pre-marking is performed in the preoperative preparation centering on laparoscopic surgery, the conventional inking method causes intrabulk dispersion and peritonitis. Therefore, we cooperated with the development of the fluorescent clip and evaluated its usefulness and safety from the fact that it was approved.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Usefulness and safety of fluorescence-guided surgery. Whether blood flow observation is possible. Whether clip position observation is possible

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

Targeting cases of fluorescence-guided surgery for digestive cancer in 5 year

Key exclusion criteria

Not applicable

Target sample size

250


Research contact person

Name of lead principal investigator

1st name Masashi
Middle name
Last name Yoshida

Organization

International University of Health and Welfare Hospital

Division name

Department of Surgery

Zip code

329-2763

Address

537-3, Iguchi, Nasushiobara City, Tochigi

TEL

0287-37-2221

Email

masashi@iuhw.ac.jp


Public contact

Name of contact person

1st name Masashi
Middle name
Last name Yoshida

Organization

International University of Health and Welfare Hospital

Division name

Department of Surgery

Zip code

329-2763

Address

537-3, Iguchi, Nasushiobara City, Tochigi

TEL

0287-37-2221

Homepage URL


Email

masashi@iuhw.ac.jp


Sponsor or person

Institute

Department of Surgery International University of Health and Welfare Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Surgery International University of Health and Welfare Hospital

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

Department of Surgery International University of Health and Welfare Hospital

Address

537-3 Iguchi Nasushiobara City Tochigi

Tel

0287-37-2221

Email

masashi@iuhw.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

2019 Year 07 Month 13 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.sciencedirect.com/science/article/pii/S1743919120304969

Number of participants that the trial has enrolled

30

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

Completed

Date of protocol fixation

2019 Year 04 Month 25 Day

Date of IRB

2019 Year 04 Month 25 Day

Anticipated trial start date

2019 Year 04 Month 25 Day

Last follow-up date

2024 Year 04 Month 25 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The upper and lower digestive tract endoscopy is performed before surgery and a fluorescent clip is used as a marking clip.


Management information

Registered date

2019 Year 07 Month 13 Day

Last modified on

2020 Year 07 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042599


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name