UMIN-ICDS Clinical Trial

Unique ID issued by UMIN	UMIN000049815
Receipt number	R000056739
Scientific Title	Comparison of the imaging and surgical quality between positive and negative staining in indocyanine green fluorescence-guided laparoscopic liver resection: a randomized controlled trial
Date of disclosure of the study information	2023/01/01
Last modified on	2023/07/23 11:28:22

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Basic information

Public title

A trial of the imaging and surgical quality of indocyanine green staining method in laparoscopic liver resection

Acronym

A trial of ICG staining method in laparoscopic liver resection

Scientific Title

Comparison of the imaging and surgical quality between positive and negative staining in indocyanine green fluorescence-guided laparoscopic liver resection: a randomized controlled trial

Scientific Title:Acronym

RCT for comparing ICG positive and negative staining in fluorescence-guided liver resection

Region

Japan

Condition

Hepatocellular carcinoma, metastatic liver cancer, intrahepatic cholangiocarcinoma, benign liver tumor

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

The purpose of this study is to compare the accuracy of liver segmentation between positive and negative staining during laparoscopic liver resection in order to achieve precise anatomic resection such as segmentectomy based on preoperative planning. Furthermore, long-term outcomes can be future research of such precise anatomic resection.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

To determine the ability of the guidance in anatomic resection, the primary endpoint is the success rate of the ICG staining which consists of a subjective optical scoring based on three components: superficial demarcation in the liver surface, visualization of parenchymal borders, and consistency with the preoperative three-dimensional (3D) simulation. The resection margin and the shape/weight of the specimen in comparison with the pre- and post-operative 3D simulations of the liver will be evaluated as well.

Key secondary outcomes

Short-term surgical outcomes and recurrence-free survival at 1-year

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

Negative staining group:
At the early phase during the surgery, extrahepatic (extrafascial) Glissonean approach is performed to encircle the target Glissonean pedicle feeding the tumorous area exactly corresponded to the preoperative simulation. Sequentially, the inflow blockage is confirmed by using laparoscopic intraoperative ultrasonography (IOUS) with doppler mode. Since the staining is irreversible after the ICG injection, 0.15ml/kg of ultrasound contrast medium (SONAZOID, Daiichi-Sankyo, Tokyo, Japan) are systematically injected prior to ICG injection. If the target area is correctly in cyanosis, 0.5 mg/body of ICG is intravenously injected for ICG negative staining method. As for near-infrared camera system, 1688 Advanced Imaging Modalities Platform (Stryker Co., MI, USA) was used for all cases.The liver transection is performed using CUSA and other energy devices.

Interventions/Control_2

Positive staining group:
The portal branches of tumor-bearing liver segments are targeted and punctured under ultrasound guidance with an 18- or 21- gauge needle introduced through the abdominal wall. The direction of the needle is assisted by the needle hole in a dedicated laparoscopic ultrasound probe (provided by BK Medical, Herlev, Denmark). Subsequently, a small amount of ICG (determined in the pilot study) is injected into the portal branch slowly for avoiding the risk of ICG retrograde flow into neighboring segments. The liver transection will be performed using CUSA and other energy devices.

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

The inclusion criteria are as follows: male or female patients with primary or metastatic liver tumors, 20 years or older, scheduled for elective LLR, preserved liver function, able to understand the nature of the study, and willing to join and give voluntary written consent. Liver functional reserve will be evaluated by serum biochemical tests (albumin level, total bilirubin level and prothrombin time) and ICG retention rate at 15 minutes (ICG-15R). The severity of liver function is assessed based on Child-Pugh stages and the liver damage classification defined by the Liver Cancer Study Group of Japan.15 Preserved liver function is defined as an ICG-15R less than 15% and a Child-Pugh classification A or B.

Key exclusion criteria

The exclusion criteria are as follows: repeat liver resection, tumor in segment 1, severe liver or renal insufficiency, ICG hypersensitivity, pregnant or breastfeeding, or unable to understand the nature of the study or refuse it.

Target sample size

Research contact person

Name of lead principal investigator

1st name Taiga

Middle name

Last name Wakabayashi

Organization

Ageo Central General Hospital

Division name

Center for Advanced Treatment of Hepatobiliary and Pancreatic Diseases

Zip code

362-8588

Address

1-10-10 Kashiwaza, Ageo, Saitama 362-8588, Japan

TEL

0487731111

Email

taiga.wakabayashi@me.com

Public contact

Name of contact person

1st name Taiga

Middle name

Last name Wakabayashi

Organization

Ageo Central General Hospital

Division name

Center for Advanced Treatment of Hepatobiliary and Pancreatic Diseases

Zip code

362-8588

Address

1-10-10 Kashiwaza, Ageo, Saitama 362-8588, Japan

TEL

0487731111

Homepage URL

Email

taiga.wakabayashi@me.com

Sponsor or person

Institute

Ageo Central General Hospital

Institute

Department

Personal name

Funding Source

Organization

Ageo Central General Hospital

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

Ageo Central General Hospital

Address

1-10-10 Kashiwaza, Ageo, Saitama 362-8588, Japan

Tel

0487731111

Email

taiga.wakabayashi@me.com

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2023 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

Anonymized data, study protocols and informed consent forms can be shared. Data requesters must sign a data access agreement and must be approved by their IRB. Requests can be made within 3 to 36 months after publication.

IPD sharing Plan description

*Will individual participant data be available (including data dictionaries)?
Yes

*What data in particular will be shared?

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

*What other documents will be available?
Study Protocol and Informed Consent Form

*When will data be available (start and end dates)? Beginning 3 months and ending 36 months following article publication.

*With whom?
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

*For what types of analyses?
To achieve aims in the approved proposal.

*By what mechanism will data be made available?
Proposals should be directed to taiga.wakabayashi@me.com. To gain access, data requestors will need to sign a data access agreement. Proposals may be submitted up to 36 months following article publication.

Progress

Recruitment status

Preinitiation

Date of protocol fixation

2022 Year 08 Month 26 Day

Date of IRB

2022 Year 08 Month 26 Day

Anticipated trial start date

2023 Year 01 Month 01 Day

Last follow-up date

2025 Year 12 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 12 Month 18 Day

Last modified on

2023 Year 07 Month 23 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056739

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name