UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025333
Receipt number R000028931
Scientific Title Clinical trial of thoracoscopic segmentectomy using infrared thoracoscopy with indocyanine green
Date of disclosure of the study information 2017/01/01
Last modified on 2019/12/23 19:54:35

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Basic information

Public title

Clinical trial of thoracoscopic segmentectomy using infrared thoracoscopy with indocyanine green

Acronym

Thoracoscopic segmentectomy using infrared thoracoscopy with indocyanine green

Scientific Title

Clinical trial of thoracoscopic segmentectomy using infrared thoracoscopy with indocyanine green

Scientific Title:Acronym

Thoracoscopic segmentectomy using infrared thoracoscopy with indocyanine green

Region

Japan


Condition

Condition

Primary lung cancer
Metastatic lung tumor
Benign lung tumor
Infectious lung tumor
Segmentectomy due to passive reasons

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Comparative analysis of identification of segmental plane using infrared thoracoscopy with indocyanine green or inflation-deflation technique

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Coincidence ratio of identification of segmental plan between infrared thoracoscopy with indocyanine green and inflation-deflation technique

Key secondary outcomes

Identification ratio of segmental plane using infrared thoracoscopy with indocyanine green in all cases
Identification ratio of segmental plane using infrared thoracoscopy with indocyanine green in cases of failure of inflation-deflation technique
Safety of using indocyanine green


Base

Study type

Interventional


Study design

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



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Indocyanine green 0.5 mg/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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients over 20 years old in obtaining written informed consent.
2. Indication of diseases
A. cT1aN0M0, stage IA primary lung cancer with peripheral located, the diameter of 2 cm or smaller, and securing enough surgical margin at least the same diameter of the tumor size (same condition of JCOG0802/WJOG4607L)
B. Metastatic lung tumor
C. Benign tumor
D. Infectious nodule
E. segmentectomy due to passive reasons (e.g. insufficient pulmonary function)
3. Patients with obtaining written informed consent

Key exclusion criteria

1. Patients with indocyanine green allergy
2. Patients with iodine allergy
3. Patients with liver cirrhosis (Child-Pugh grade B or worse)
4. Clinicians decide to exclude from this trial in some reasons.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Toshiki
Middle name
Last name Tanaka

Organization

Yamaguchi University Hospital

Division name

Department of Surgery and Clinical Science

Zip code

755-8505

Address

1-1-1 Minami-kogushi, Ube, Yamaguchi 755-8505, Japan

TEL

0836222261

Email

kaueda@yamaguchi-u.ac.jp


Public contact

Name of contact person

1st name Toshiki
Middle name
Last name Tanaka

Organization

Yamaguchi University Hospital

Division name

Department of Surgery and Clinical Science

Zip code

755-8505

Address

1-1-1 Minami-kogushi, Ube, Yamaguchi 755-8505, Japan

TEL

0836-22-2261

Homepage URL


Email

tanakat@yamaguchi-u.ac.jp


Sponsor or person

Institute

Yamaguchi University Hospital

Institute

Department

Personal name



Funding Source

Organization

Yamaguchi University 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

Yamaguchi University Hospital

Address

1-1-1 Minami-kogushi, Ube, Yamaguchi 755-8505, Japan

Tel

0836-22-2428

Email

me223@yamaguchi-u.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 01 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

Completed

Date of protocol fixation

2016 Year 11 Month 01 Day

Date of IRB

2017 Year 04 Month 26 Day

Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date

2018 Year 08 Month 31 Day

Date of closure to data entry

2018 Year 08 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 12 Month 20 Day

Last modified on

2019 Year 12 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028931


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name