UMIN-CTR Clinical Trial

Basic information
Public title	Automated Surgical Workflow Identification By Artificial Intelligence In Laparoscopic Hepatectomy
Acronym	AI For Laparoscopic Hepatectomy
Scientific Title	Automated Surgical Workflow Identification By Artificial Intelligence In Laparoscopic Hepatectomy
Scientific Title:Acronym	AI For Laparoscopic Hepatectomy
Region	Japan

Condition
Condition	Hepatocellular Carcinoma Metastatic Cancer Of The Liver Intrahepatic Cholangiocarcinoma
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To develop novel intraoperative systems of computer-assisted surgery for laparoscopic hepatectomy.
Basic objectives2	Others
Basic objectives -Others	To develop a deep-learning model for automated surgical step identification in laparoscopic hepatectomy.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The evaluation metrics for the model were precision, recall, F1 score (which were used as the metrics for each step), and overall accuracy (which was used for the integrated steps).
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	40 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	We constructed a dataset containing 40 cases of pure laparoscopic hepatectomy partial resection procedures, all of which were performed by four surgeons at the National Cancer Center Hospital East (NCCHE) in Kashiwa, Japan, between July 2018 and December 2019.
Key exclusion criteria	None
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Masaaki Middle name Last name Ito
Organization	National Cancer Center Hospital East
Division name	Surgical Device Innovation Office
Zip code	277-8577
Address	6-5-1, Kashiwanoha, Kashiwa-City, Chiba 277-8577, Japan
TEL	0471-33-1111
Email	maito@east.ncc.go.jp

Public contact
Name of contact person	1st name Masaaki Middle name Last name Ito
Organization	National Cancer Center Hospital East
Division name	Surgical Device Innovation Office
Zip code	277-8577
Address	6-5-1, Kashiwanoha, Kashiwa-City, Chiba 277-8577, Japan
TEL	0471-33-1111
Homepage URL
Email	maito@east.ncc.go.jp

Sponsor
Institute	Surgical Device Innovation Office, National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board, National Cancer Center Hospital East
Address	6-5-1, Kashiwanoha, Kashiwa-City, Chiba 277-8577, Japan
Tel	0471-33-1111
Email	irst@ml.res.ncc.go.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 07 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	40
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	Main results already published
Date of protocol fixation	2020 Year 09 Month 30 Day
Date of IRB	2020 Year 09 Month 30 Day
Anticipated trial start date	2020 Year 09 Month 30 Day
Last follow-up date	2025 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Research Project No. 2020-315 Title: Analytical research on surgical information using a database of surgical videos of endoscopic surgeries

Management information
Registered date	2022 Year 07 Month 20 Day
Last modified on	2022 Year 07 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055183