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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007317
Receipt No. R000008536
Scientific Title Multi-institutional study of chemotherapy-associated liver injury in patients with colorectal hepatic metasasis
Date of disclosure of the study information 2012/03/01
Last modified on 2013/09/17

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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
Middle name
Last name Kanemitsu Yukihide
Organization National Cancer Center Hospital
Division name Department of Colorectal Surgery
Zip code
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
Middle name
Last name Shinichiro Takahashi
Organization National Cancer Center Hospital East
Division name Department of Hepato-Biliary Pancreatic Surgery
Zip code
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
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
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 No longer recruiting
Date of protocol fixation
2012 Year 01 Month 14 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
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
2013 Year 09 Month 17 Day


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

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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