UMIN-CTR Clinical Trial

Public title

Prospective Study for Optimal Length of Bowel Resection in Colon Cancer Surgery

Acronym

Prospective Study for Optimal Length of Bowel Resection in Colon Cancer Surgery

Scientific Title

Prospective Study for Optimal Length of Bowel Resection in Colon Cancer Surgery

Scientific Title:Acronym

Prospective Study for Optimal Length of Bowel Resection in Colon Cancer Surgery

Region

Japan

Condition

Colon cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To clarify the actual status of metastatic LN distribution in colon cancer and identify the optimal length of bowel resection in colon cancer surgery

Basic objectives2

Others

Basic objectives -Others

To obtain evidence for standardized colon cancer surgery

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Distribution and incidence of metastatic lymph nodes

Key secondary outcomes

Incidence of recurrence according to the length of bowel resection

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Histologically proven colon adenocarcinoma
2. Pathological stage I, II or III
3. Pericolic regional lymph nodes are dissected according to the Japanese Classification of Colorectal Carcinoma (7th edition)
4. Bowel resection at 10 cm or more from a tumour edge
5. Informed consent for observational data collection

Key exclusion criteria

1. Patients with preoperative chemotherapy
2. Multiple colon cancer (excluding Tis)

Target sample size

3000

Name of lead principal investigator

1st name	Hideki
Middle name
Last name	Ueno

Organization

National Defense Medical College

Division name

Department of Surgery

Zip code

359-8513

Address

3-2, Namiki, Tokorozawa, Saitama

TEL

04-2995-1637

Email

ueno_surg1@ndmc.ac.jp

Name of contact person

1st name	Hideki
Middle name
Last name	Ueno

Organization

National Defense Medical College

Division name

Department of Surgery

Zip code

359-8513

Address

3-2, Namiki, Tokorozawa, Saitama

TEL

04-2995-1637

Homepage URL

http://www.jsccr.jp/project/proj_coloncancer.html

Email

ueno_surg1@ndmc.ac.jp

Institute

Japanese Society for Cancer of the Colon and Rectum

Institute

Department

Personal name

Organization

Japanese Society for Cancer of the Colon and Rectum

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board, Japanese Society for Cancer of the Colon and Rectum

Address

Sanbancho KS Bldg., 2 Sanbancho, Chiyoda-ku, Tokyo 102-0075, Japan

Tel

03-3263-8697

Email

jsccr@secretariat.ne.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

恵佑会札幌病院（北海道）、山形県立中央病院（山形県）、新潟県立がんセンター新潟病院（新潟県）、国立がん研究センター東病院（千葉県）、帝京大学ちば総合医療センター（千葉県）、防衛医科大学校（埼玉県）、栃木県立がんセンター（栃木県）、埼玉県立がんセンター（埼玉県）、国立がん研究センター中央病院（東京都）、東京医科歯科大学大学院（東京都）、帝京大学医学部（東京都）、がん・感染症センター駒込病院（東京都）、杏林大学医学部付属病院（東京都）、東京女子医科大学（東京都）、横浜市立大学医学部（神奈川県）、済生会横浜市南部病院（神奈川県）、神奈川県立がんセンター（神奈川県）、横浜市立大学付属市民総合医療センター（神奈川県）、静岡県立静岡がんセンター（静岡県）、愛知県立がんセンター中央病院（愛知県）、藤田保健衛生大学（愛知県）、三重大学大学院医学系研究科（三重県）、滋賀医科大学（滋賀県）、大阪国際がんセンター（大阪府）、和歌山県立医科大学（和歌山県）、久留米大学（福岡県）、大腸肛門病センター高野病院（熊本県）

Date of disclosure of the study information

2017

Year

12

Month

12

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.thelancet.com/journals/lanwpc/article/PIIS2666-6065(22)00295-4/fulltext

Number of participants that the trial has enrolled

2996

Results

In 99.8%, the primary feeding artery was distributed within 10 cm of the primary tumour. The metastatic pericolic node most distant from the tumour was within 3 cm in 837 patients, 3-5 cm in 130 patients, 5-7 cm in 39 patients and 7-10 cm in 34 patients. Only four patients (0.1%) had pericolic lymphatic spread beyond 10 cm. None of the 2996 patients developed recurrence in the remaining pericolic nodes.

Results date posted

2023

Year

12

Month

30

Day

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

Recruitment status

Main results already published

Date of protocol fixation

2013

Year

05

Month

30

Day

Date of IRB

2013

Year

05

Month

30

Day

Anticipated trial start date

2013

Year

06

Month

01

Day

Last follow-up date

2023

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1. Study design:
Multicenter prospective cohort study

2. Patient recruitment:
All patients with colon cancer surgery between June 2013 and December 2017 at the participating institutions who satisfy the selection criteria for this study.

3. Parameters collected:
Patient characteristics
-Age
-Gender
-Height
-Weight

Tumor characteristics
-Tumor location
-pT stage
-Differentiation grade

Surgery-related characteristics
-Year and month of surgery
-Surgical method
-Intraoperative marking for measurement (under direct vision / laparoscopic)
-Resection margin

Items associated with feeding artery
-Accuracy of intraoperative identification
-Pattern of distribution
-Distance from the primary tumor

Lymph node (LN) distribution
-Number of LNs retrieved and involved LNs according to LN region

Prognostic outcomes
-Year and month of last follow-up
-Prognostic outcomes and cause of death
-Year and month of recurrence
-Recurrence pattern

Registered date

2017

Year

12

Month

10

Day

Last modified on

2023

Year

12

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034640