UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020539
Receipt number R000023716
Scientific Title Efficacy of Endoscopic Covered Metal Stenting for Malignant Gastric Outlet Obstruction
Date of disclosure of the study information 2016/01/12
Last modified on 2016/08/02 17:12:36

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Basic information

Public title

Efficacy of Endoscopic Covered Metal Stenting for Malignant Gastric Outlet Obstruction

Acronym

Clinical benefit of Endoscopic Covered Metal Stenting

Scientific Title

Efficacy of Endoscopic Covered Metal Stenting for Malignant Gastric Outlet Obstruction

Scientific Title:Acronym

Clinical benefit of Endoscopic Covered Metal Stenting

Region

Japan


Condition

Condition

Malignant gastric outlet obstruction (GOO)

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the efficacy and benefit of covered self-expandable metallic stent (C-SEMS) compared with uncovered self-expandable metallic stent(U-SEMS).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To claryfy the stent-related predictive factors of poor oral intake.

Key secondary outcomes

Investigate the patient-related redictive factors of poor oral intake.


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

Malignant gastric outlet obstruction (GOO) patients, who consent to participate in the study in Nagoya City University Hospital and research cooperation facilities

Key exclusion criteria

Not obtained the consent

Target sample size

126


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuki Hori

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Gastroenterology and Metabolism

Zip code


Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan

TEL

+81-52-853-8211

Email

yhori@med.nagoya-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Itaru Naitoh

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Gastroenterology and Metabolism

Zip code


Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan

TEL

+81-52-853-8211

Homepage URL


Email

inaito@med.nagoya-cu.ac.jp


Sponsor or person

Institute

Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Nagoya Daini Red cross Hospital,
Gifu Prefectural Tajimi Hospital,
Kasugai Municipal Hospital,
Nagoya City West Medical Center
Toyokawa City Hospital
Japan Community Health Care Organization
Midori Municipal Hospital
Gamagori City Hospital

Name of secondary funder(s)

None


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

2016 Year 01 Month 12 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/27475489

Number of participants that the trial has enrolled


Results

No significant difference was observed between the U-SEMS and C-SEMS groups with respect to technical success, clinical success, GOO score or time to stent dysfunction. Stent migration was significantly more frequent in patients with C-SEMS. Karnofsky performance status, chemotherapy, peritoneal dissemination, and stent underexpansion were associated significantly with poor GOO score improvement in multivariable analyses, but stent type was not. In subgroup analyses, insufficient stent expansion was an independent factor in patients with U-SEMS, but not in C-SEMS. In the insufficient stent expansion subgroup, C-SEMS was associated significantly with superior clinical improvement compared with U-SEMS. Insufficient stent expansion was observed more frequently in patients with gastrointestinal obstruction due to anastomotic sites or metastatic cancer.
In conclusion, no clinical difference, apart from stent migration, was observed between patients with U-SEMS and C-SEMS. Gastrointestinal obstruction due to an anastomotic site or metastatic cancer may be an indication for C-SEMS use to improve oral intake after SEMS placement.

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

Completed

Date of protocol fixation

2004 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2004 Year 01 Month 01 Day

Last follow-up date

2015 Year 12 Month 31 Day

Date of closure to data entry

2016 Year 03 Month 31 Day

Date trial data considered complete

2016 Year 03 Month 31 Day

Date analysis concluded

2016 Year 04 Month 30 Day


Other

Other related information

Samples are collected from subjects who participated in this study in Nagoya City University Hospital and research affiliated facilities.
Samples and clinical information without containing personal information are numbered and managed in Nagoya City University Hospital. Consecutive paitents who underwent covered metallic stenting for malignant gastric outlet obstruction in affiliated institutions from 2004.


Management information

Registered date

2016 Year 01 Month 12 Day

Last modified on

2016 Year 08 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023716


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name