UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006160
Receipt number R000007252
Scientific Title The study to evaluate the efficacy of lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery for rectal cancer
Date of disclosure of the study information 2011/09/01
Last modified on 2021/05/25 15:31:00

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Basic information

Public title

The study to evaluate the efficacy of lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery for rectal cancer

Acronym

The efficacy of lymph node dissection with preservation of the left colic artery for rectal cancer

Scientific Title

The study to evaluate the efficacy of lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery for rectal cancer

Scientific Title:Acronym

The efficacy of lymph node dissection with preservation of the left colic artery for rectal cancer

Region

Japan


Condition

Condition

Rectal Cancer

Classification by specialty

Surgery in general Gastrointestinal surgery Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery for rectal cancer surgery in reducing incidence of anastomotic leakage

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence of anastomotic leakage

Key secondary outcomes

Conversion rate in lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery
3-year disease-free survival
Exploratory study of the risk factor for anastomotic leakage


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

lymph node dissection around the inferior mesenteric artery without preservation of the left colic artery

Interventions/Control_2

lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery

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) Histologically proven rectal adenocarcinoma
2) Distal extent of tumor must be in the rectum (within 15cm from the anal verge as determined via endoscopy or confirmed by barium enema or sagittal slice of MRI/CT)
3) Clinical Stage
Tumor depth of invasion: T2, T3 or T4
Lymph node metastasis: N0, N1, N2 or N3
No distant metastasis: M0
4) Age more than 20years old
5) Elective (low) anterior resection with lymph node dissection around the inferior mesenteric artery
6) No previous surgery for middle colic artery or inferior mesenteric artery
7) Preserved organ function within 6 weeks before registraion
White blood cell count>=3,000/ul
Platelet cpunt>=100,000/ul
GOT<=100 IU/L
GPT<=100 IU/L
Total bilirubin<=2.0 mg/dl
Creatinine<=1.5 mg/dl
8) written informed consent

Key exclusion criteria

1) Synchronous colorectal carcinoma
2) Pregnant women, possibly pregnant women, and nursing mothers
3) Complicated with psychosis
4) Myocardial infarction within six months or unstable angina
5) Severe pulmonary emphysema or pulmonary fibrosis
6) Uneder systemic steroid therapy
7) Required for a intersphincteric resection
8) Other conditions not suitable for this study

Target sample size

1460


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsugu Sekimoto

Organization

Osaka University Hospital

Division name

Department of Surgery

Zip code


Address

2-2 Yamadaoka Suita City Osaka

TEL

06-6879-3251

Email



Public contact

Name of contact person

1st name
Middle name
Last name Masataka Ikeda Tsunekazu Mizushima

Organization

Osaka University Graduate School of Medicine

Division name

Department of Surgery

Zip code


Address

2-2 Yamadaoka, Suita, Osaka 565-0871,Japan

TEL

06-6879-3251

Homepage URL


Email

tmizushima@gesurg.med.osaka-u.ac.jp


Sponsor or person

Institute

Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Institute

Department

Personal name



Funding Source

Organization

None

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


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



Other administrative information

Date of disclosure of the study information

2011 Year 09 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

2011 Year 07 Month 22 Day

Date of IRB


Anticipated trial start date

2011 Year 10 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



Management information

Registered date

2011 Year 08 Month 12 Day

Last modified on

2021 Year 05 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007252


Research Plan
Registered date File name
2016/07/06 ★直腸癌手術における左結腸動脈温存の意義に関する検討 (2).zip

Research case data specifications
Registered date File name

Research case data
Registered date File name