UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Niti-s colonic MD type stent prospective feasibility study
Title of the study (Brief title)	Colonic stent "MD type" prospective feasibility study
Region	Japan

Condition
Condition	Colo-rectal Cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This registy's objective is to compile clinical experience of use of the Colonic Stent for the treatment of malignant colo-rectal strictures.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical success rate of the colonic stenting
Key secondary outcomes

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	Preoperative treatment of colorectal obstruction caused by malignant neoplasms BTS and patients requiring palliative treatment. Patients who has never received a colonic stenting procedure.
Key exclusion criteria	Intestinal ischemia Suspicion or impending perforation Intraperitoneal sbscess / perforation Patients who can not apply endoscopic procedures Patients who have severe organ disorder Patients who have been registered in this study Patients who were judged not eligible for participation in this study
Target sample size	200

Research contact person
Name of lead principal investigator	Toshio Kuwai
Organization	National Hospital Organization, Kure Medical Center and Chugoku Cancer Center
Division name	Gastroenterology
Address	3-1 Aoyama-cho, Kure, Hiroshima
TEL	0823-22-3111
Email	kuwait@kure-nh.go.jp

Public contact
Name of contact person	Yuzuru Tamaru
Organization	National Hospital Organization, Kure Medical Center and Chugoku Cancer Center
Division name	Gastroenterology
Address	3-1 Aoyama-cho, Kure, Hiroshima
TEL	0823-22-3111
Homepage URL
Email	tamaruy@kure-nh.go.jp

Sponsor
Institute	National Hospital Organization, Kure Medical Center and Chugoku Cancer Center
Institute
Department

Funding Source
Organization	National Hospital Organization, Kure Medical Center and Chugoku Cancer Center
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 11 Month 10 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 09 Month 14 Day
Anticipated trial start date	2018 Year 09 Month 14 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	Observational study about the feasibility of Niti-s colonic MD type stent This is a single arm study. The target objective is preoperative treatment of colorectal obstruction caused by malignant neoplasms BTS and patients requiring palliative treatment.

Management information
Registered date	2018 Year 11 Month 10 Day
Last modified on	2018 Year 11 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039737