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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002206
Receipt No. R000002714
Scientific Title Study on the effects of the through the scope type of the self-expandable metallic stent on the patients with the gastric outlet obstruction because of inoperable advanced cancer.
Date of disclosure of the study information 2009/07/20
Last modified on 2012/02/08

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Basic information
Public title Study on the effects of the through the scope type of the self-expandable metallic stent on the patients with the gastric outlet obstruction because of inoperable advanced cancer.
Acronym Effect of the metallic stent on the gastric outlet obstruction.
Scientific Title Study on the effects of the through the scope type of the self-expandable metallic stent on the patients with the gastric outlet obstruction because of inoperable advanced cancer.
Scientific Title:Acronym Effect of the metallic stent on the gastric outlet obstruction.
Region
Japan

Condition
Condition gastric outlet obstruction from gastric cancer, pancreatic cancer, biliary cancer, and metastatic cancer.
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To study the effectiveness of metallic stent on the patients with gastric outlet obstruction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes technical success, clinical success, morbidty, hospital stay period
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 group of the patients with metallic stent
Interventions/Control_2 group of the patients with by-pass operation
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 patients with gastric outlet obstruction due to advanced cancer
Key exclusion criteria patients with more than PS4, patients with peritonitis carcinomatosa, patients with multiple obstruction of the GI truct
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Aiura
Organization keio University Hospital
Division name Center for Diagnostic and Thrapeutic Endoscopy
Zip code
Address Shinanomachi 35, Shinnjuku-ku, Tokyo 160-8582
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University Hospital
Division name Center for Diagnostic and Thrapeutic Endoscopy
Zip code
Address
TEL 03-3353-1211
Homepage URL
Email

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization non
Organization
Division
Category of Funding Organization Self funding
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
2009 Year 07 Month 20 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 Terminated
Date of protocol fixation
2009 Year 07 Month 08 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2014 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 07 Month 15 Day
Last modified on
2012 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002714

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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