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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004841
Receipt No. R000005744
Scientific Title Multicenter study for the endoscopic management of malignant gastric outlet obstruction with WallFlex duodenal stent (MUST-GOOD study)
Date of disclosure of the study information 2011/01/07
Last modified on 2012/01/07

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Basic information
Public title Multicenter study for the endoscopic management of malignant gastric outlet obstruction with WallFlex duodenal stent (MUST-GOOD study)
Acronym Multicenter study for the endoscopic management of malignant gastric outlet obstruction with WallFlex duodenal stent (MUST-GOOD study)
Scientific Title Multicenter study for the endoscopic management of malignant gastric outlet obstruction with WallFlex duodenal stent (MUST-GOOD study)
Scientific Title:Acronym Multicenter study for the endoscopic management of malignant gastric outlet obstruction with WallFlex duodenal stent (MUST-GOOD study)
Region
Japan

Condition
Condition Unresectable malignant gastric outlet obstruction
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of WallFlex duodenal stent.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Duration of oral food intake.
Key secondary outcomes Stent patency, Stent obstruction rate, Complication, Event-free survival, Survival, QOL, Status of oral food intake.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Placement of WallFlex duodenal stent for malignant gastric outlet obstruction.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Unresectable malignant gastric outlet obstruction.
2. More than 18 years of age.
3. Written informed consent was able to obtain from the patient.
Key exclusion criteria 1. Performance status >=4.
2. The patient with severe comorbidity.
3. Multiple stenosis case
4. Inappropriate case judged by physician.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Iruru Maetani
Organization Toho University Ohashi Medical Center
Division name Division of Gastroenterology, Department of Internal Medicine
Zip code
Address 2-17-6, Ohashi, Meguro-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Sasaki
Organization The University of Tokyo Hospital
Division name Department of Gastroenterology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization None
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
2011 Year 01 Month 07 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 No longer recruiting
Date of protocol fixation
2010 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 01 Month 07 Day
Last modified on
2012 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005744

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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