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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032648
Receipt No. R000037227
Scientific Title A retrospective cohort study evaluating the treatment outcome and prognosis after endoscopic resection using ligation device (EMRL) for colorectal neuroendocrine tumors (NET)
Date of disclosure of the study information 2018/05/19
Last modified on 2019/01/08

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Basic information
Public title A retrospective cohort study evaluating the treatment outcome and prognosis after endoscopic resection using ligation device (EMRL) for colorectal neuroendocrine tumors (NET)
Acronym Efficacy of EMRL and prognosis of rectal NETs
Scientific Title A retrospective cohort study evaluating the treatment outcome and prognosis after endoscopic resection using ligation device (EMRL) for colorectal neuroendocrine tumors (NET)
Scientific Title:Acronym Efficacy of EMRL and prognosis of rectal NETs
Region
Japan

Condition
Condition colorectal neuroendocrine tumors (NET)
Classification by specialty
Gastroenterology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of EMRL for the treatment of colorectal NET, and To evaluate long-term outcomes after endoscopic treatment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Completion rare/R0 resection rate
Recurrence rate
Key secondary outcomes Procedure time, complication rate (perforation, delayed-bleeding), pathological findings


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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with colorectal NET
Key exclusion criteria 1. Cases in which it is difficult to get informed consent
2. Cases which are considered as inappropriate by doctors
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Sakai
Organization NTT Medical Center Tokyo
Division name Department of Gastroenterology
Zip code
Address 5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL 08033828342
Email eiji525@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Sakai
Organization NTT Medical Center Tokyo
Division name Department of Gastroenterology
Zip code
Address 5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL 03-3448-6111
Homepage URL
Email eiji525@yokohama-cu.ac.jp

Sponsor
Institute NTT Medical Center Tokyo
Institute
Department

Funding Source
Organization NTT Medical Center Tokyo
Organization
Division
Category of Funding Organization Other
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
2018 Year 05 Month 19 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 05 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 05 Month 19 Day
Last modified on
2019 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037227

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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