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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004566
Receipt No. R000005275
Scientific Title Efficacy of gastrointestinal stent (Niti-S Stent) in the malignant gastrointestinal stricture
Date of disclosure of the study information 2010/11/16
Last modified on 2013/03/25

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Basic information
Public title Efficacy of gastrointestinal stent (Niti-S Stent) in the malignant gastrointestinal stricture
Acronym Efficacy of gastrointestinal stent (Niti-S Stent)
Scientific Title Efficacy of gastrointestinal stent (Niti-S Stent) in the malignant gastrointestinal stricture
Scientific Title:Acronym Efficacy of gastrointestinal stent (Niti-S Stent)
Region
Japan

Condition
Condition Inoperable malignant gastrointestinal stricture
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The gastrointestinal stricture to assume a malignancy origin causes gastrointestinal obstruction. A bypass operation is chosen in the inoperable case, but it is invasive way, and a lot of cases cannot undergo the surgery, too. Stent treatment becomes the insurance adaptation about the stricture of the esophagus, but the stent for the large intestine is out of insurance adaptation in Japan. The stent insertion for the inoperable malignancy gastrointestinal stricture has been performed for more than decade, and in western countries, it is it with treatment of the standard in substitution for a conventional bypass operation. The comparison with the stent and the bypass operation are performed by domestic and foreign researchers, and they report the superiority to the decrease of the hospitalization days, shortening of the period to a meal start, the reduction of the medical examination and treatment cost. However, in Japan, we substituted stent of esophagus for the obstruction of the large intestine, because stent for exclusive use of digestive organs was not marketed till now. Because it was the device to insert under fluoroscopicb guidance, an insertion manual skill had difficulty with high flexibility through by a stomach and the sigmoid colon. This new device (Niti-S Stent®) can be inserted thorugh the scope, we can expect the decrease of procedure time and the complication by introduction. In this study, we apply this self-expandable metallic stent (SEMS) for the stricture of stomach, duodenum and large intestine by various kinds of malignancies to evaluate the utility and safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Main endp-oint
Feeding possibility rate, patency and rate of obstruction
Subsidiary end-point
The frequency and the type of the complication, duration of survival
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 self-expandable metallic stent (SEMS)
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient with inoperable malignant
gastrointestinal stricture
An adult older than 20 years old
Any underlying disease and the sex
The patient that a document agreement
by the free will of the patient himself after having received enough explanation
Key exclusion criteria Patient with difficulty by endoscopic approach
Patient who have gastrointestinal passage obstacle symptom by cancerous peritonitis
Patient without informed consent
Uncontrolled severe organ dysfunction
Inappropriate subject judged by doctor
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Isayama
Organization The University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo Bunkyo-ku, Tokyo 113-8655, Japan.
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The University of Tokyo
Division name Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute The University of Tokyo
Institute
Department

Funding Source
Organization The University of Tokyo
Organization
Division
Category of Funding Organization
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
2010 Year 11 Month 16 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
2006 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2006 Year 03 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
2010 Year 11 Month 16 Day
Last modified on
2013 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005275

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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