UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026193 |
|---|---|
| Receipt number | R000029804 |
| Scientific Title | Observational study on the therapeutic effect of endoscopic stent placement for malignant gastroduodenal obstruction |
| Date of disclosure of the study information | 2017/02/17 |
| Last modified on | 2021/02/20 10:15:45 |
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Basic information
Public title
Observational study on the therapeutic effect of endoscopic stent placement for malignant gastroduodenal obstruction
Acronym
DS study
Scientific Title
Observational study on the therapeutic effect of endoscopic stent placement for malignant gastroduodenal obstruction
Scientific Title:Acronym
DS study
Region
| Japan |
Condition
Condition
Malignant gastroduodenal obstruction
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of endoscopic stent placement on malignant gastroduodenal obstruction and predictive factors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of predictive factors for stent treatment effect
Key secondary outcomes
Occurrence of stent malfunction and overall survival
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have organic stenosis or obstruction in the stomach or duodenum due to malignant tumors and cause impaired food passage. The primary organ of the tumor does not matter.
Key exclusion criteria
Patients who are stenotic or obstructed by esophagus or gastric cardia etc., and it is difficult to perform endoscopic stent placement. In addition, a patient whose research director or researcher judged inappropriate endoscopic stent placement surgery.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Kaneko |
Organization
Kanazawa University Hospital
Division name
Department of Gastroenterology
Zip code
9208641
Address
13-1,Takara-machi,Kanazawa
TEL
076-265-2000
skaneko@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Takatori |
Organization
Kanazawa University Hospital
Division name
Department of Gastroenterology
Zip code
9208641
Address
13-1,Takara-machi,Kanazawa
TEL
076-265-2235
Homepage URL
takatori@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University Hospital
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University Hospital
Department of Gastroenterology
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
Kanazawa University Medical Ethics Review Committee
Address
13-1,Takara-machi,Kanazawa
Tel
0762652110
crc.irb-knz@esct.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
| 2017 | Year | 02 | Month | 17 | 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
| 2016 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Presence of ascites
Site and range of stenosis
Stent retention date
Successful completion of stent placement
Stent placement site
Number of stents
Type of stent (product name, diameter, length, presence or absence of cover)
Feeding situation (GOOSS score) and performance status (ECOG and KPS) 7 days before detention, detention, 7 days after detention , 14 days later
Management information
Registered date
| 2017 | Year | 02 | Month | 17 | Day |
Last modified on
| 2021 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029804
