UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018622 |
|---|---|
| Receipt number | R000021544 |
| Scientific Title | Safety and Efficacy of Associating Liver Partition and Portal vein ligation for Staged hepatectomy (ALPPS) |
| Date of disclosure of the study information | 2015/08/10 |
| Last modified on | 2015/08/10 14:05:27 |
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Basic information
Public title
Safety and Efficacy of Associating Liver Partition and Portal vein ligation for Staged hepatectomy (ALPPS)
Acronym
Safety and Efficacy of Associating Liver Partition and Portal vein ligation for Staged hepatectomy (ALPPS)
Scientific Title
Safety and Efficacy of Associating Liver Partition and Portal vein ligation for Staged hepatectomy (ALPPS)
Scientific Title:Acronym
Safety and Efficacy of Associating Liver Partition and Portal vein ligation for Staged hepatectomy (ALPPS)
Region
| Japan |
Condition
Condition
Metastatic liver disease
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of Associating Liver Partition and Portal vein ligation for Staged hepatectomy (ALPPS) for unresectable metastatic liver disease after portal embolization
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The ratio of resectable cases afyer ALPPS
The ratio of ro resection
Key secondary outcomes
Complication
Overall survival rate
Disease free survival rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The treatment for the unresectable liver metastasis
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
In 20 years of age or older, patients who received a diagnosis of unresectable liver metastases.
And gender does not matter.
In anesthesiology of examination, cases that have been determined to be possible for operation.
It should be noted that the unresectable liver metastasis, even after the portal vein embolization therapy enforcement,
1) Hyogo College of Medicine prognosis score> 50 and, 2) I will be a case of Zankimo ICG-K value <0.05.
Do not allow the distant metastases other than liver metastases.
The Eastern Cooperative Oncology Group (ECOG) Performance Status is a 0-1
In response to sufficient explanation for this test content, written consent of the person has been obtained
Key exclusion criteria
Patient other than the above
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Takeda |
Organization
Yokohama city University Hospital
Division name
Gastroenterological surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama city, 236-0004 , Japan
TEL
045-787-2800
kazutake@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Takeda |
Organization
Yokohama city University Hospital
Division name
Gastroenterological surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama city, 236-0004 , Japan
TEL
045-787-2800
Homepage URL
kazutake@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
横浜市立大学附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 10 | Day |
Last modified on
| 2015 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021544
