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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006160
Receipt No. 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

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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
Institute Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Institute
Department

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
URL(English) https://upload.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


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