UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004841 |
|---|---|
| Receipt number | 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 | 2022/07/18 12:48:56 |
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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 | Iruru |
| Middle name | |
| Last name | Maetani |
Organization
Toho University Ohashi Medical Center
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
153-8515
Address
2-22-36, Ohashi, Meguro-ku, Tokyo
TEL
03-3468-1251
mtnir50637@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Sasaki |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
sasakit-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo Hospital Ethics Review Board
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel
03-5800-8743
crctky-office@umin.ac.jp
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
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 23 | Day |
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
| 2022 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005744
