UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030488
Receipt number R000034807
Scientific Title Intraoperative evaluation of blood flow using idocyanine green fluorescence imaging in surgery for biliary-pancreatic cancer
Date of disclosure of the study information 2017/12/21
Last modified on 2023/06/30 19:04:59

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Basic information

Public title

Intraoperative evaluation of blood flow using idocyanine green fluorescence imaging in surgery for biliary-pancreatic cancer

Acronym

Intraoperative evaluation of blood flow using idocyanine green fluorescence imaging in surgery for biliary-pancreatic cancer

Scientific Title

Intraoperative evaluation of blood flow using idocyanine green fluorescence imaging in surgery for biliary-pancreatic cancer

Scientific Title:Acronym

Intraoperative evaluation of blood flow
using ICG for biliary-pancreatic cancer

Region

Japan


Condition

Condition

biliary-pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To verify the systematic lymph node dissection for biliary-pancreatic cancer using
ICG imaging

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

the number of dissected lymph node

Key secondary outcomes

the ratio of lymph node matastasis
operative time
intraoperative bleeding
morbidity
outcome


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

1) Intraoperative administration
Direct injection of 0.2ml of ICG solution at parenchyma close to cancer with a 27-gauge needle.
2) Intraoperatice administration
Intraoperative administration using endoscope: injection of a 0.2ml 0f 0.5% ICG solution at parenchyma close to cancer
3) Preoperative administration using endoscope: Injection of a 0.2ml of 0.5% ICG solution at parenchyma close to cancer



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

85 years-old >

Gender

Male and Female

Key inclusion criteria

Patiets who need pancreaticoduodenectomy, or distal pancreatic rescection, or bile duct resection.

Key exclusion criteria

1) Patients with iodine allergy
2) Patients with ICG allergy

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Okamoto
Middle name
Last name Tomoyoshi

Organization

Jikei University School of Medicine Daisan Hospital

Division name

Depatment of surgery

Zip code

2018601

Address

4-11-1 Izumihoncho, Komae city, Tokyo, Japan

TEL

03-3480-1151

Email

tomoka@jikei.ac.jp


Public contact

Name of contact person

1st name Futagawa
Middle name
Last name Yasuro

Organization

Jikei University School of Medicine Daisan Hospital

Division name

Depatment of surgery

Zip code

2018601

Address

4-11-1 Izumihoncho, Komae city, Tokyo, Japan

TEL

03-3480-1151

Homepage URL


Email

tiger@jikei.ac.jp


Sponsor or person

Institute

Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Jikei University School of Medicine

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

The Jikei University School of Medicine

Address

3-25-8 Nishishinbashi, Minato-KU, Tokyo, Japan

Tel

0334331111

Email

rinri@jikei.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

東京慈恵会医科大学附属第三病院


Other administrative information

Date of disclosure of the study information

2017 Year 12 Month 21 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

41

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events

no complications

Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2016 Year 12 Month 06 Day

Date of IRB

2016 Year 10 Month 12 Day

Anticipated trial start date

2017 Year 12 Month 21 Day

Last follow-up date

2024 Year 09 Month 30 Day

Date of closure to data entry

2024 Year 09 Month 30 Day

Date trial data considered complete

2024 Year 09 Month 30 Day

Date analysis concluded

2024 Year 12 Month 30 Day


Other

Other related information



Management information

Registered date

2017 Year 12 Month 20 Day

Last modified on

2023 Year 06 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034807


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name