UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Endoscopic Covered Metal Stenting for Malignant Gastric Outlet Obstruction
Title of the study (Brief title)	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	Yasuki Hori
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Gastroenterology and Metabolism
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	Itaru Naitoh
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Gastroenterology and Metabolism
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
TEL	+81-52-853-8211
Homepage URL
Email	inaito@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
Institute
Department

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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2004 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/27475489
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023716