UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled trial to compare surgical effectiveness of tumor enucleation versus systematic segmentectomy for resecting hepatocellular carcinoma
Acronym	A randomized comparison of enucleation versus segmentectomy for hepatocellular carcinoma
Scientific Title	A randomized controlled trial to compare surgical effectiveness of tumor enucleation versus systematic segmentectomy for resecting hepatocellular carcinoma
Scientific Title:Acronym	A randomized comparison of enucleation versus segmentectomy for hepatocellular carcinoma
Region	Japan

Condition
Condition	Cases with hepatocellular carcinoma scheduled to undergo hepatic resection.
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the disease-free survival after tumor enucleation or systematic segmentectomy for resecting hepatocellular carcinoma in a randomized controlled trial.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Disease-free survival
Key secondary outcomes	Overall survival, disease-specific survival, postoperative complication

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	As an operative procedure, the patients are randomly assigned to undergo tumor enucleation for resecting hepatocellular carcinoma.
Interventions/Control_2	As an operative procedure, the patients are randomly assigned to undergo systematic segmentectomy for resecting hepatocellular carcinoma.
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	18 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Clinically-proven hepatocellular carcinoma less than 50 mm in diameter. 2. Stage-1, 2, or 3 tumor in UICC-TNM classification. 3. Hepatic function of no ascites, total serum bilirubin value less than 1.0mg/dL, and indocyanine clearance rate less than 30%.
Key exclusion criteria	1. Recurrent hepatocellular carcinoma within 2 years after primary hepatic resection. 2. Multiple hepatocellular carcinoma. 3. Simultaneous other malignant disorders.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tadatoshi Takayama
Organization	Nihon University School of Medicine
Division name	Department of Digestive Surgery
Zip code
Address	30-1 Oyaguchikami-machi, Itabashi-ku, Tokyo 173-8610
TEL	03-3554-2345
Email	takayama.tadatoshi@nihon-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tadatoshi Takayama
Organization	Nihon University School of Medicine
Division name	Department of Digestive Surgery
Zip code
Address	30-1 Oyaguchikami-machi, Itabashi-ku, Tokyo 173-8610
TEL	03-3554-2345
Homepage URL
Email	takayama.tadatoshi@nihon-u.ac.jp

Sponsor
Institute	Department of Digestive Surgery, Nihon University School of Medicine
Institute
Department

Funding Source
Organization	Foundation for Promotion of Cancer Research, Tokyo
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Nihon University Itabashi Hospital, Surugadai Nihon University Hospital, Nihon University Nerima-Hikarigaoka Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2005 Year 11 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
IPD sharing Plan description

Progress
Recruitment status
Date of protocol fixation	2003 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date	2003 Year 04 Month 01 Day
Last follow-up date	2010 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2005 Year 08 Month 29 Day
Last modified on	2017 Year 09 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000137

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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