UMIN-CTR 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
Condition
Hepatocellular carcinoma, metastatic liver cancer, intrahepatic cholangiocarcinoma, benign liver tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
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
2
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
50
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
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
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
taiga.wakabayashi@me.com
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
| 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/ctr_e/ctr_view.cgi?recptno=R000056739
