UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025442 |
|---|---|
| Receipt number | R000029260 |
| Scientific Title | Efficacy of endoscopic resection for duodenal tumors; a single center prospective study |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2020/07/10 18:18:47 |
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Basic information
Public title
Efficacy of endoscopic resection for duodenal tumors; a single center prospective study
Acronym
Efficacy of endoscopic resection for duodenal tumors
Scientific Title
Efficacy of endoscopic resection for duodenal tumors; a single center prospective study
Scientific Title:Acronym
Efficacy of endoscopic resection for duodenal tumors
Region
| Japan |
Condition
Condition
Duodenal tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The feasibility of endoscopic resection for duodenal tumors is evaluated in a clinical study
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Five-year relapse-free survival rate
Key secondary outcomes
Procedure success rate, En bloc resection rate, Pathological diagnosis, Complications, Procedure time, Amount of bleeding, Three-year relapse-free survival rate, Relapse-free survival time, Three or five-year overall survival rate, Quality of life after procedure
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
| Maneuver |
Interventions/Control_1
Endoscopic resection
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
This study involves patients who undergo endoscopic resection for duodenal tumors.
Key exclusion criteria
Patients whose lesions are found to invade submucosal layer by the preceding endoscopic check up before treatment, Patients who are stopped for an unavoidable reason during treatment
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Naohisa |
| Middle name | |
| Last name | Yahagi |
Organization
Keio University School of Medicine
Division name
Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3914
yahagi.keio@gmail.com
Public contact
Name of contact person
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University School of Medicine
Division name
Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3914
Homepage URL
moto28hiko@icloud.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
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
Research ethics committee, Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3914
med-rinri-jimu@adst.keio.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
| 2017 | Year | 04 | Month | 01 | 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
| 2016 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 27 | Day |
Last modified on
| 2020 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029260
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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