UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Predictors of stent dysfunction after self-expandable metal stent placement for malignant gastric outlet obstruction
Title of the study (Brief title)	Predictors for stent dysfunction in GOO
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 evaluate predictors of stent dysfunction, especially stent ingrowth in uncovered self-expandable metallic stent (U-SEMS) and migration in covered self-expandable metallic stent (C-SEMS), those are main causes of stent dysfunction.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To claryfy the predictors of stent dysfunction.
Key secondary outcomes	Investigate the predictors of stent ingrowth in U-SEMS and migration in C-SEMS.

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	252

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	名古屋第二赤十字病院（愛知県）、岐阜県立多治見病院（岐阜県）、春日井市民病院（愛知県）、名古屋市西部医療センター（愛知県）、豊川市民病院（愛知県）、中京病院（愛知県）、緑市民病院（愛知県）、蒲郡市民病院（愛知県）

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 14 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 10 Month 01 Day
Date trial data considered complete	2016 Year 10 Month 01 Day
Date analysis concluded	2016 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/28281116
Results	Both U-SEMS and C-SEMS are effective with comparable patencies. Tumor ingrowth and stent migration are the main causes of stent dysfunction for U-SEMS and C-SEMS, respectively. With regard to stent dysfunction, U-SEMS might be a good option for patients receiving chemotherapy, while C-SEMS with longer stents for patients in good condition.
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 metallic stenting for malignant gastric outlet obstruction in affiliated institutions from 2004.

Management information
Registered date	2016 Year 09 Month 14 Day
Last modified on	2017 Year 03 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027416