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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014955
Receipt No. R000017398
Scientific Title A prospective study for laparoscopic low anterior resection of rectum with lateral pelvic lymph node dissection in patients with advanced lower rectal cancer
Date of disclosure of the study information 2014/09/01
Last modified on 2016/11/16

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Basic information
Public title A prospective study for laparoscopic low anterior resection of rectum with lateral pelvic lymph node dissection in patients with advanced lower rectal cancer
Acronym laparoscopic lateral pelvic lymph node dissection in patients with advanced lower rectal cancer
Scientific Title A prospective study for laparoscopic low anterior resection of rectum with lateral pelvic lymph node dissection in patients with advanced lower rectal cancer
Scientific Title:Acronym laparoscopic lateral pelvic lymph node dissection in patients with advanced lower rectal cancer
Region
Japan

Condition
Condition advanced lower rectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of laparoscopic lateral lymph node dissection in patients with advanced lower rectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes incidence of complication
Key secondary outcomes 3-year local recurrence-free survival,3-year recurrece-free survival,recurrence-free survival,overall survival,operative time,intraoperative bleeding,transition to open surgery,completion of surgery, number of dissected lateral lymph node, voiding dysfunction, hospital days after surgery

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 Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 laparoscopic lateral pelvic lymph node dissection
Interventions/Control_2 lateral lymph node dissection by open surgery
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
75 years-old >=
Gender Male and Female
Key inclusion criteria (1) Histologically confirmed adenocarcinoma
(2)recquirement to all of follows by preoperative diagnostic imaging
1.invasion depth is more than T3, or metastasis in N1, N2 lymph node
2.Main lesion of the tumor is located at the rectum
3.Lower tumor margin is below the peritoneal reflection
4.No extramesorectal lymph node swelling (Shorter diameter is less than 10 mm)
5.No invasion to other organ (s)
(3) no past history of pelvic radiation
(4)without multiple malignancies
(5)Patient age is more than 20 and less than 75
(6)PS: 0, 1
(7)adequate organ function
(8) Written informed consent
Key exclusion criteria 1.Multiple malignancies to be treated
2.Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
3.Intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer
4.Uncontrolled severe complications(DM, hypertension, diarrhea, et al.)
5.Massive pleural effusion or ascites that required drainage.
6.Patient with symptomatic cardiovascular disease or asymptomatic disease but has been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year.
7.With interstitial lung disease or pulmonary fibrosis
8.Continuous systemic steroid therapy (oral or intravenous administration)
9.A history and/or current evidence of significant neurological and/or mental illness
10.Not appropriate for the study at the physician's assessment
Target sample size 22

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kinoshita
Organization Aichi Prefectural cancer center
Division name Colorectal Surgery Division
Zip code
Address 1-1 Kanokoden Chikusa-ku, Nagoya, Aichi
TEL 052-762-6111
Email t-kinoshita@h2.dion.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Wada
Organization M's system
Division name data center
Zip code
Address 4902-1-5-D Hirokute Asahimae-cho Owariasahi Aichi
TEL 0561-51-5590
Homepage URL
Email marobon@dream.com

Sponsor
Institute Chubu Clinical Oncology 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
2014 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 Enrolling by invitation
Date of protocol fixation
2014 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 12 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
2014 Year 08 Month 26 Day
Last modified on
2016 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017398

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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