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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020410
Receipt No. 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

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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
Email 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
Email yamazaki-nmed@umin.ac.jp

Sponsor
Institute Department of Digestive Surgery, Nihon University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023571

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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