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UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000086
Receipt No. R000000137
Scientific Title A randomized controlled trial to compare surgical effectiveness of tumor enucleation versus systematic segmentectomy for resecting hepatocellular carcinoma
Date of disclosure of the study information 2005/11/01
Last modified on 2017/09/14

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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
Registered date File name

Research case data
Registered date File name


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