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

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 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

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

Value
https://center6.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