UMIN-CTR Clinical Trial

Basic information
Public title	Study on the usefulness of laparoscopic liver resection for hepatocellular carcinoma
Acronym	Study on the usefulness of laparoscopic liver resection for hepatocellular carcinoma
Scientific Title	Study on the usefulness of laparoscopic liver resection for hepatocellular carcinoma
Scientific Title:Acronym	Study on the usefulness of laparoscopic liver resection for hepatocellular carcinoma
Region	Japan

Condition
Condition	Hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To verify the usefulness of laparoscopic liver resection by comparing the perioperative outcomes of laparoscopic and open liver resection for hepatectomy in hepatocellular carcinoma
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of posthepatectomy liver failure
Key secondary outcomes	Postoperative blood tests on 1, 2, 3, 5, and 7 days after hepatectomy. Platelet counts, international normalized ratio of prothrombin time, total bilirubin, and alanine aminotransferase. operation time, blood loss, perioperative complication rate, perioperative mortality, length of hospital stay after surgery

Base
Study type	Observational

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	A case of liver resection for hepatocellular carcinoma in kyoto university hospital from January 2011 to December 2019
Key exclusion criteria	Patients who did not consent to this study
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Kojiro Middle name Last name Taura
Organization	Graduate School of Medicine, Kyoto University
Division name	Hepato Biliary Pancreatic Surgery and Transplantation
Zip code	606-8507
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL	075-751-3242
Email	ktaura@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Kojiro Middle name Last name Taura
Organization	Graduate School of Medicine, Kyoto University
Division name	Hepato Biliary Pancreatic Surgery and Transplantation
Zip code	606-8507
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL	075-751-3242
Homepage URL
Email	ktaura@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	none
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	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel	0757534680
Email	ethcom@kuhp.kyoto-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	2020 Year 08 Month 03 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	344
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	Completed
Date of protocol fixation	2018 Year 05 Month 14 Day
Date of IRB	2018 Year 06 Month 20 Day
Anticipated trial start date	2018 Year 06 Month 20 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 06 Month 19 Day

Other
Other related information	Retrospective cohort study All patients who underwent surgery for hepatocellular carcinoma at Kyoto University Hospital from January 2011 to December 2019 and met the selection criteria

Management information
Registered date	2020 Year 08 Month 03 Day
Last modified on	2020 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047142