UMIN-CTR Clinical Trial

Basic information
Public title	Lymphadenectomy around ileocolic artery and vein for advanced right-sided colon cancer
Acronym	Lymphadenectomy around ileocolic artery and vein for advanced right-sided colon cancer
Scientific Title	Lymphadenectomy around ileocolic artery and vein for advanced right-sided colon cancer
Scientific Title:Acronym	Lymphadenectomy around ileocolic artery and vein for advanced right-sided colon cancer
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the metastatic lymph nodes around ileocolic artery and vein for advanced right-sided colon cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	metastasis rate of lymph nodes around ileocolic artery and vein
Key secondary outcomes	None

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 with radical surgery for advanced right-sided colon cancer
Key exclusion criteria	None
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Manabu Middle name Last name Shiozawa
Organization	Kanagawa Cancer Center
Division name	Department of Gastrointestinal Surgery
Zip code	241-8515
Address	2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL	045-520-2222
Email	shiozawam@kcch.jp

Public contact
Name of contact person	1st name Sumito Middle name Last name Sato
Organization	Kanagawa Cancer Center
Division name	Department of Gastrointestinal Surgery
Zip code	241-8515
Address	2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL	045-520-2222
Homepage URL
Email	su.sato@kcch.jp

Sponsor
Institute	Kaagawa Cancer Center
Institute
Department

Funding Source
Organization	Kanagawa Canecer Center
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	Kanagawa Cancer Center
Address	2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
Tel	0455202222
Email	chiken-jim4@kcch.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	2018 Year 01 Month 18 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://link.springer.com/article/10.1007/s00423-020-02016-5
Number of participants that the trial has enrolled	91
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 10 Month 21 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 05 Day
Date of IRB	2017 Year 12 Month 07 Day
Anticipated trial start date	2017 Year 12 Month 07 Day
Last follow-up date	2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study to decide the properly lymphadenectomy area around ileocolic artery and vein for advanced right-sided colon cancer

Management information
Registered date	2018 Year 01 Month 18 Day
Last modified on	2021 Year 01 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035265