UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter cohort study on lymph node metastasis region and frequency in splenic flexural colon cancer
Acronym	SP study
Scientific Title	Multicenter cohort study on lymph node metastasis region and frequency in splenic flexural colon cancer
Scientific Title:Acronym	SP study
Region	Japan

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

Objectives
Narrative objectives1	The purpose is to survey the status of lymph node metastasis to the accessory middle colon artery region in splenic flexural colon cancer and to clarify whether it is meaningful to dissect as the main artery as well as the middle colon artery and left colon artery .
Basic objectives2	Others
Basic objectives -Others	observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency of lymph node metastassis to the accessory middle colic artery
Key secondary outcomes	Frequency of lymph node metastassis to the middle colic artery and left colic artery

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients who are 20 years old or older 2 Patients with histologically proven colon cancer 3 The central part of the tumor is within 10 cm from the splenic flexure 4 patients diagnosed with cStage1-3 by preoperative imaging 5 Patients scheduled to undergo lymph node dissection with D2 or greater. However, even if D0/D1 dissection is performed during surgery, it is not excluded.
Key exclusion criteria	1 Patients with distant metastasis. However, we do not exclude cases where distant lesions are pointed out accidentally during surgery. 2 Patients with multiple cancer (except for Tis lesions) 3 Patients with a history of colorectal cancer resection
Target sample size	139

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Watanabe
Organization	Yokohama City University Medical Center
Division name	Department of surgery, Gastroenterological Center
Zip code	232-0024
Address	4-57, Urafune-cho,Minami-ku,Yokohama
TEL	045-261-5656
Email	nabe-jun@comet.ocn.ne.jp

Public contact
Name of contact person	1st name Jun Middle name Last name Watanabe
Organization	Yokohama City University Medical Center
Division name	Department of surgery, Gastroenterological Center
Zip code	232-0024
Address	4-57, Urafune-cho,Minami-ku,Yokohama
TEL	045-261-5656
Homepage URL
Email	nabe-jun@comet.ocn.ne.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Self funding
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	Ethics Committee of Yokohama City University
Address	3-9, Fukuura Kanazawa-ku Yokohama
Tel	045-787-2800
Email	rinri@yokohama-cu.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	2019 Year 06 Month 27 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	Completed
Date of protocol fixation	2018 Year 07 Month 03 Day
Date of IRB	2019 Year 05 Month 14 Day
Anticipated trial start date	2019 Year 06 Month 27 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

For removed specimens in surgical treatment 1) Unfold the extracted sample in vivo and fix it on a plate with a pin. Mark the stump at the blood vessel and the junction with the marginal artery. 2) The lymph nodes are searched while clarifying the dominant blood vessels and the marginal arteries, and pathological diagnosis based on Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma is performed. 3) Classify the lymph nodes according to the definition, including the presence of the accessory middle colon artery.

Management information
Registered date	2019 Year 06 Month 27 Day
Last modified on	2022 Year 12 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042393