UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A retrospective cohort study evaluating the treatment outcome and prognosis after endoscopic resection using ligation device (EMRL) for colorectal neuroendocrine tumors (NET)
Title of the study (Brief title)	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	Eiji Sakai
Organization	NTT Medical Center Tokyo
Division name	Department of Gastroenterology
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	Eiji Sakai
Organization	NTT Medical Center Tokyo
Division name	Department of Gastroenterology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 05 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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