UMIN-CTR Clinical Trial

Basic information
Public title	Multi-institutional study of chemotherapy-associated liver injury in patients with colorectal hepatic metasasis
Acronym	Study of chemotherapy-associated liver injury
Scientific Title	Multi-institutional study of chemotherapy-associated liver injury in patients with colorectal hepatic metasasis
Scientific Title:Acronym	Study of chemotherapy-associated liver injury
Region	Japan

Condition
Condition	colorectal liver metastasis
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate influence of chemotherapy-associated liver injury on morbidity after hepatic resection.
Basic objectives2	Others
Basic objectives -Others	To verify whether liver biopsy is necessory for evaluation of chemotherapy-associated liver injury when chemotherapy-associated liver injury correlated with morbidity after hepatic resection.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Morbidity rate after hepatic resection according to extent of chemotherapy-associated liver injury
Key secondary outcomes	Exploratory investigation of pathological findings in chemotherapy-associated liver injury Risk factor for morbidity after hepati cresection

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have undergone second liver resection for colorectal hepatic metastasis irrespective of history of systemic chemotherapy (with more than 6 months follow-up after resection).
Key exclusion criteria	1.Second liver resection not for the treatment of colorectal liver metastasis. 2.History of ablation therapy. 3.History of hepatic arterial infusion therapy. 4.Second liver resection after portal vein embolization.
Target sample size	240

Research contact person
Name of lead principal investigator	1st name Yukihide Middle name Last name Kanemitsu
Organization	National Cancer Center Hospital
Division name	Department of Colorectal Surgery
Zip code	1040045
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL	03-3547-5201
Email	ykanemit@ncc.go.jp

Public contact
Name of contact person	1st name Shinichiro Middle name Last name Takahashi
Organization	National Cancer Center Hospital East
Division name	Department of Hepato-Biliary Pancreatic Surgery
Zip code	2778577
Address	Kashiwanoha 6-5-1, Kashiwa, Chiba
TEL	04-7133-1111
Homepage URL
Email	shtakaha@east.ncc.go.jp

Sponsor
Institute	Department of Hepato-Biliary Pancreatic Surgery, National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	National Cancer Center
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	National Cancer Center Institutional Review Board
Address	5-chome-1-1 Tsukiji, Chuo City, Tokyo-to 104-0045
Tel	03-3542-2511
Email	NCC_IRBoffice@ml.res.ncc.go.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	茨城県立中央病院 宮城県立がんセンター 国立がんセンター東病院 千葉県がんセンター 神奈川県立がんセンター 横浜市立大学附属市民総合医療センター 新潟県立がんセンター新潟病院 石川県立中央病院 愛知県がんセンター中央病院 大阪府立病院機構大阪府立成人病センター 箕面市立病院 市立吹田市民病院 兵庫医科大学病院 広島市立広島市民病院 国立病院機構四国がんセンター 久留米大学病院 大分大学医学部附属病院 札幌厚生病院 杏林大学医学部付属病院 慶応義塾大学病院 東京医科歯科大学医学部附属病院 昭和大学横浜市北部病院 長野市民病院 静岡県立静岡がんセンター 市立堺病院 国立病院機構京都医療センター 国立がんセンター中央病院 都立駒込病院 関西労災病院

Other administrative information
Date of disclosure of the study information	2012 Year 03 Month 01 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	218
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	It takes time to proofread the manuscript.
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	No longer recruiting
Date of protocol fixation	2012 Year 01 Month 14 Day
Date of IRB	2011 Year 10 Month 21 Day
Anticipated trial start date	2012 Year 03 Month 01 Day
Last follow-up date	2017 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	1.Exploratory investigation of influence of chemotherapy-associated liver injury on morbidity after hepatic resection 2.Study to verify whether liver biopsy is necessory for evaluation of chemotherapy-associated liver injury when chemotherapy-associated liver injury correlated with morbidity after hepatic resection.

Management information
Registered date	2012 Year 02 Month 17 Day
Last modified on	2021 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008536