UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047155
Receipt number R000053791
Scientific Title the study of Intraoperative imaging by indocyanine green (ICG) fluorescence in laparoscopic deroofing for liver cyst
Date of disclosure of the study information 2022/03/17
Last modified on 2024/09/14 10:07:58

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Basic information

Public title

the study of Intraoperative imaging by indocyanine green (ICG) fluorescence in laparoscopic deroofing for liver cyst

Acronym

the study of Intraoperative imaging by indocyanine green (ICG) fluorescence in laparoscopic deroofing for liver cyst

Scientific Title

the study of Intraoperative imaging by indocyanine green (ICG) fluorescence in laparoscopic deroofing for liver cyst

Scientific Title:Acronym

Intraoperative imaging by indocyanine green (ICG) fluorescence in laparoscopic deroofing for liver cyst

Region

Japan


Condition

Condition

liver cyst

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In this study, it is performed during endoscopic surgery using the ICG fluorescence method, and the purpose is to clarify the identification of cyst wall and liver parenchyma boundary and biliary tract (intrahepatic bile duct, bile duct run in cyst wall) at the time of deroofing by visualizing blood vessels and organs in the living body, and to reduce complications.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety and accuracy in the identification of Bile leakage or bile duct injury in laparoscopic deroofing

Key secondary outcomes

Evaluation of the boundary between cyst wall and liver parenchyma and biliary tract in laparoscopic deroofing. In addition to other items related to surgery such as operation time and blood loss, information extracted from medical records such as medical history


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Indocyanine Green 2.5mg . once immediately before surgery

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Preoperative diagnosis is diagnosed as a hepatic cyst and a case of deroofing performed.
2) Cases judged by a facility liability doctor or a allotment doctor to have an intraoperative general condition and liver reserve ability
3) The age at the time of obtaining consent must be 20 years of age or older.
4) The applicant must be explained using explanatory documents and have obtained written consent from the person in question.

Key exclusion criteria

1) A case with a history of hypersensitivity to ICG.
2) If you have a history of hypersensitivity in iodine contrast agents.
3) A case with a history of severe hypersensitivity.
4) Adult and cases that are not sufficiently judgmental.
5) Adult and unconscious cases.
6) When it is necessary to consider the disease name
7) If the examiner or assigned physician deems it inappropriate to participate in this study.
8) We do not target those who study "socially vulnerable people".

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Otsuka
Middle name
Last name Yichiro

Organization

Omori Hospital, Toho University Medical Center

Division name

Department of Surgery, General and Gastroenterological surgery

Zip code

1438541

Address

6-11-1 Omori nishi, Ota-ku, Tokyo

TEL

03-3762-4151

Email

yotsuka@med.toho-u.ac.jp


Public contact

Name of contact person

1st name Kimura
Middle name
Last name Kazutaka

Organization

Omori Hospital, Toho University Medical Center

Division name

Department of Surgery, General and Gastroenterological surger

Zip code

1438541

Address

6-11-1 Omori nishi, Ota-ku, Tokyo

TEL

03-3762-4151

Homepage URL


Email

kazutaka.kimura@med.toho-u.ac.jp


Sponsor or person

Institute

Toho University

Institute

Department

Personal name



Funding Source

Organization

Toho University

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

Omori Hospital, Toho University Medical Center

Address

6-11-1 Omori nishi, Ota-ku, Tokyo

Tel

03-3762-4151

Email

kazutaka.kimura@med.toho-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

2022 Year 03 Month 17 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

Enrolling by invitation

Date of protocol fixation

2021 Year 12 Month 31 Day

Date of IRB

2022 Year 03 Month 17 Day

Anticipated trial start date

2022 Year 03 Month 18 Day

Last follow-up date

2025 Year 03 Month 18 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 03 Month 11 Day

Last modified on

2024 Year 09 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053791