UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000086 |
|---|---|
| Receipt number | 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 | 2021/04/09 14:21:26 |
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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 | Tadatoshi |
| Middle name | |
| Last name | Takayama |
Organization
Nihon University School of Medicine
Division name
Department of Digestive Surgery
Zip code
173-8610
Address
30-1 Oyaguchikami-machi, Itabashi-ku, Tokyo 173-8610
TEL
03-3554-2345
takayama.tadatoshi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadatoshi |
| Middle name | |
| Last name | Takayama |
Organization
Nihon University School of Medicine
Division name
Department of Digestive Surgery
Zip code
173-8610
Address
30-1 Oyaguchikami-machi, Itabashi-ku, Tokyo 173-8610
TEL
03-3554-2345
Homepage URL
takayama.tadatoshi@nihon-u.ac.jp
Sponsor or person
Institute
Department of Digestive Surgery, Nihon University School of Medicine
Institute
Department
Personal name
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
Ethics Committee of Nihon University School of Medicine
Address
30-1 Oyaguchikami-machi, Itabashi-ku, Tokyo 173-8610
Tel
03-3972-8111
odagiri.hikaru@nihon-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
日本大学医学部消化器外科（東京都）
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
| 2021 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000137
