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UMIN-CTR Clinical Trial |
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Name: | 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 |
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 | |
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Condition | ||
Condition | Cases with hepatocellular carcinoma scheduled to undergo hepatic resection. | |
Classification by specialty |
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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 |
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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 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 | ||||||
takayama.tadatoshi@nihon-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Last modified on |
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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 |