UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020410 |
|---|---|
| Receipt number | R000023571 |
| Scientific Title | Anatomical vs. Non-Anatomical resection of colorectal liver metastases: a randomized controlled trial |
| Date of disclosure of the study information | 2015/12/31 |
| Last modified on | 2020/07/04 09:09:09 |
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Basic information
Public title
Anatomical vs. Non-Anatomical resection of colorectal liver metastases: a randomized controlled trial
Acronym
ANA-RCT
Scientific Title
Anatomical vs. Non-Anatomical resection of colorectal liver metastases: a randomized controlled trial
Scientific Title:Acronym
ANA-RCT
Region
| Japan |
Condition
Condition
colorectal liver metastases
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To crify the optimal operation procedure in colorectal liver metastases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
3-year recurrence-free survival
Key secondary outcomes
Overall survival
Intraoperative blood loss
Distance of surgical maergin
postoperative complication
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
The patients who has colorectal liver metasis less than 4 Couinaud segment were randomized equally to limited resection.
Interventions/Control_2
The patients who has colorectal liver metasis less than 4 Couinaud segment were randomized equally to anatomical resection.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Typical colorectal liver metastasis in enhanced CT and were resectable for surgical treatment less than 4 Couinaud segments. 2 No evidence of massive vessel invasion 3 Good liver functional reserve Child-Pugh score less than 7point. 4 Judged as "Resectable tumor status" in our surgical review board. 5 Good general condition ECOG performance status: 0-2. 6 Optimal other organ status.
Key exclusion criteria
1 Have active other cancer (within 5year) Except for carcinoma in situ. 2 OMI or unstable angina within 6 month before operation. 3 Bad prumonary status Idiopathic pulmonary fibrosis, severe emphysema. 4 iodine hypersensitivity Bad renal function: serum creatinin >1.5 mg/dL. 5 unstable mental disease. 6 possivility of pregnant
Target sample size
400
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
1738610
Address
30-1 Ohyaguchikami-machi Itabashi-ku Tokyo Japan
TEL
03-3972-8111
takayama.tadatoshi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Yamazaki |
Organization
Nihon University School of Medicine
Division name
Department of Digestive Surgery
Zip code
1738610
Address
30-1 Ohyaguchikami-machi Itabashi-ku Tokyo Japan
TEL
03-3972-8111
Homepage URL
yamazaki-nmed@umin.ac.jp
Sponsor or person
Institute
Department of Digestive Surgery, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon university school of medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon university school of medicine
Address
30-1 Ohyaguchikami-machi Itabashi-ku Tokyo Japan
Tel
03-3972-8111
yamazaki-nmed@umin.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 31 | 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
250
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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 31 | Day |
Last modified on
| 2020 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023571
