UMIN-CTR Clinical Trial

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

Inoperable malignant gastrointestinal stricture

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

The University of Tokyo

Institute

Department

Personal name

Organization

The University of Tokyo

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

11

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2010

Year

11

Month

16

Day

Last modified on

2013

Year

03

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005275