UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Colonic Stent prospective feasibility study
Title of the study (Brief title)	Colonic Stent prospective feasibility study
Region	Japan

Condition
Condition	malignant colo-rectal strictures
Classification by specialty	Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this registry 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	Not applicable

Assessment
Primary outcomes	Clinical Efficacy of Colonic Stent, associated to Obstruction Relief and Permeability
Key secondary outcomes	Additional data related to the procedure and the product: Technical success, Complications, Survival, Palliation vs Bridge to Surgery

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 requiring palliative treatment of colorectal strictures produced by malignant neoplasms. Only patients with no previous colonic stenting will be included in the registry.
Key exclusion criteria	Patients contraindicated will include those presenting - enteral ischemia - suspected or impending perforation - intrabdominal abscess / perforation - strictures that do not allow passage of a guide wire - patients for whom endoscopic techniques are contraindicated - any use other than those specifically outlined under indications of use (inclusion) A patient with a previous colonic stent implanted will not be eligible to be introduced into the registry data base.
Target sample size	200

Research contact person
Name of lead principal investigator	Yoshihisa Saida
Organization	Toho University Ohashi Medical Center
Division name	Surgery
Address	2-17-6 Ohashi Meguroku, Tokyo
TEL	03-3468-1251
Email	yoshisaida@nifty.com

Public contact
Name of contact person	Toshiyuki Enomoto
Organization	Toho University Ohashi Medical Center
Division name	Surgery
Address	2-17-6 Ohashi Meguroku, Tokyo
TEL	03-3468-1251
Homepage URL	http://colon-stent.com/
Email	eno@med.toho-u.ac.jp

Sponsor
Institute	Colonic Stent Safe Procedure Research Group
Institute
Department

Funding Source
Organization	Colonic Stent Safe Procedure Research Group
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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	2012 Year 05 Month 15 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 05 Month 01 Day
Anticipated trial start date	2012 Year 05 Month 14 Day
Last follow-up date	2014 Year 12 Month 01 Day
Date of closure to data entry	2015 Year 05 Month 01 Day
Date trial data considered complete	2016 Year 12 Month 01 Day
Date analysis concluded	2018 Year 12 Month 01 Day

Related information
URL releasing protocol	http://colon-stent.com/
Publication of results	Unpublished
URL releasing results
Results
Other related information	2012 May Planning to start

Management information
Registered date	2012 Year 05 Month 15 Day
Last modified on	2018 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009049