UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048645
Receipt number R000055426
Scientific Title A retrospective observational study on the assessment of lymphatic flow using ICG fluorescence in laparoscopic surgery for right-sided colon cancer.
Date of disclosure of the study information 2022/08/10
Last modified on 2022/08/10 20:37:31

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Basic information

Public title

A retrospective observational study on the assessment of lymphatic flow using ICG fluorescence in laparoscopic surgery for right-sided colon cancer.

Acronym

A retrospective observational study on the assessment of lymphatic flow using ICG fluorescence in laparoscopic surgery for right-sided colon cancer.

Scientific Title

A retrospective observational study on the assessment of lymphatic flow using ICG fluorescence in laparoscopic surgery for right-sided colon cancer.

Scientific Title:Acronym

A retrospective observational study on the assessment of lymphatic flow using ICG fluorescence in laparoscopic surgery for right-sided colon cancer.

Region

Japan


Condition

Condition

right-sided colon cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the usefulness of lymphatic flow assessment by ICG fluorescence using indocyanine green (ICG) in laparoscopic surgery for right-sided colon cancer, compared with a subject group not undergoing ICG fluorescence, and to determine whether lymphatic flow assessment by ICG fluorescence is useful in increasing the number of lymph nodes dissected and improving postoperative outcomes, retrospectively The aim of the study is to investigate.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

3-year recurrence-free survival rate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

with ICG local administration, 0.25 ml of ICG (2.5mg/ml) was locally injected laparoscopically into the submucosa of the colon which is near the tumor.

Interventions/Control_2

without ICG local administration

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

Laparoscopic surgery for right-sided colon cancer.

Key exclusion criteria

Patients who underwent other operations concurrently, patients who underwent a multiorgan complication resection.

Target sample size

921


Research contact person

Name of lead principal investigator

1st name Jun
Middle name
Last name Watanabe

Organization

Yokohama City University Medical Center, Yokohama, Japan

Division name

Department of Surgery, Gastroenterological Center

Zip code

232-0024

Address

4-57 Urafune-cho, Minami-ku, Yokohama-shi, Kanagawa

TEL

045-261-5656

Email

jun0926@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name Susumu
Middle name
Last name Daibo

Organization

Yokohama City University Medical Center

Division name

Department of Surgery, Gastroenterological Center

Zip code

232-0024

Address

4-57 Urafune-cho, Minami-ku, Yokohama-shi, Kanagawa

TEL

045-261-5656

Homepage URL


Email

daibo.sus.bn@yokohama-cu.ac.jp


Sponsor or person

Institute

Gastroenterological Center, Yokohama City University Medical Center

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

Clinical Trial Review Committee, Yokohama City University Hospital

Address

3-9 Fukuura, Kanazawa-ku, Yokohama-shi, 236-0004

Tel

045-787-2714

Email

chiken@yokohama-cu.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

横浜市立大学附属市民総合医療センター(神奈川県)


Other administrative information

Date of disclosure of the study information

2022 Year 08 Month 10 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

921

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

No longer recruiting

Date of protocol fixation

2022 Year 04 Month 13 Day

Date of IRB

2022 Year 07 Month 26 Day

Anticipated trial start date

2022 Year 08 Month 10 Day

Last follow-up date

2027 Year 05 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

2022 Year 08 Month 10 Day

Last modified on

2022 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=R000055426


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name