UMIN-CTR Clinical Trial

Public title

Study for safety and usefulness of thoracoscopic segmentectomy using infrared thoracoscope with indocyanine green(ICG)

Acronym

Study for safety and usefulness of thoracoscopic segmentectomy using indocyanine green(ICG)

Scientific Title

Study for safety and usefulness of thoracoscopic segmentectomy using infrared thoracoscope with indocyanine green(ICG)

Scientific Title:Acronym

Study for safety and usefulness of thoracoscopic segmentectomy using indocyanine green(ICG)

Region

Japan

Condition

lung cancer, lung cancer suspected
metastatic lung tumor, metastatic lung tumor suspected

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We study the usefulness and safety of the infrared endoscope system with indocyanine green (ICG) for identification of segmental plane in thoracoscopic lung segmentectomy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Morbidity ratio and ratio of identification of segmental plane for ICG infrared thoracoscopic technique

Key secondary outcomes

Coincidence ratio of identification of segmental plane between anatomical method, inflation-deflation technique and ICG infrared thoracoscopic technique.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Indocyanine green 0.25mg/kg is injected into a peripheral vein.

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

Age-lower limit

20

years-old

<=

Age-upper limit

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Patients over 20 years old and under 90 years old in obtaining written informed consent.
2. Patients with lung cancer or metastatic lung tumor are considered as an indication of lung segmentectomy.
3. Patients with obtaining written informed consent.

Key exclusion criteria

1. Patients with a history of side effects from ICG
2. Patients with iodine hypersensitivity
3. Women who are likely to be pregnant and possibly pregnant
4. Patients who are thought to be difficult to undergo thoracoscopic lung segmentectomy depending on the degree of tumor progression
5. Patients judged to be unable to tolerate general anesthesia, such as severe heart disease
6. Patients with infection requiring systemic treatment
7. Patients with fever at surgery
8. Patients who are complicated with psychosis or psychiatric symptoms and are considered difficult to participate in the study
9. Patients who can not obtain consent of transfusion
10. Clinicians decide to exclude from this trial in some reasons

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Hiroshi Haneda

Organization

Nagoya City University, Graduate School of Medical Sciences

Division name

Oncology, Immunology and Surgery

Zip code

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan

TEL

052-853-8231

Email

h-haneda@med.nagoya-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroshi Haneda

Organization

Nagoya City University, Graduate School of Medical Sciences

Division name

Oncology, Immunology and Surgery

Zip code

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan

TEL

052-853-8231

Homepage URL

Email

h-haneda@med.nagoya-cu.ac.jp

Institute

Oncology, Immunology and Surgery, Nagoya City University, Graduate School of Medical Sciences

Institute

Department

Personal name

Organization

Oncology, Immunology and Surgery, Nagoya City University, Graduate School of Medical Sciences

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2018

Year

01

Month

20

Day

Date of IRB

Anticipated trial start date

2018

Year

02

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

01

Month

20

Day

Last modified on

2018

Year

01

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034532