UMIN-CTR Clinical Trial

Basic information
Public title	A retrospective study of the outcome of hepatocellular carcinoma after liver resection
Acronym	A retrospective study of the outcome of hepatocellular carcinoma after liver resection
Scientific Title	A retrospective study of the outcome of hepatocellular carcinoma after liver resection
Scientific Title:Acronym	A retrospective study of the outcome of hepatocellular carcinoma after liver resection
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the therapeutic efficacy of hepatic resection for hepatocellular carcinoma
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Recurrence site of hepatocellular carcinoma
Key secondary outcomes	Recurrence-free survival, overall survival, Preoperative factor, operative factor

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent liver resection for initial hepatocellular carcinoma at Nara Medical University
Key exclusion criteria	Death by other diseases within 5 years
Target sample size	278

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Hokuto
Organization	Nara Medical University
Division name	Surgery
Zip code	634-8522
Address	840 shijyocho Kashihar Nara Japan
TEL	0744223051
Email	hokuto@naramed-u.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Hokuto
Organization	Nara Medical University
Division name	Surgery
Zip code	634-8522
Address	840 shijyocho Kashihara Nara Japan
TEL	0744223051
Homepage URL
Email	hokuto@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

Funding Source
Organization	Nara Medical 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	IRB of Nara Medical University
Address	840 shijyocho Kashihara Nara Japan
Tel	0744223051
Email	hokuto@naramed-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	2021 Year 10 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	278
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	2019 Year 06 Month 30 Day
Date of IRB	2019 Year 06 Month 30 Day
Anticipated trial start date	2019 Year 06 Month 30 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	278 patients with primary HCC who underwent curative liver resection between 2000 and 2016 at Nara Medical University Hospital were retrospectively reviewed.

Management information
Registered date	2021 Year 10 Month 21 Day
Last modified on	2021 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052308