UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037247 |
|---|---|
| Receipt number | R000042445 |
| Scientific Title | Feasibility and efficacy of endoscopic laryngo-pharyngeal surgery(ELPS) and endoscopic submucosal dissection(ESD) for pharyngeal and laryngeal tumor |
| Date of disclosure of the study information | 2019/07/03 |
| Last modified on | 2021/01/02 20:23:27 |
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Basic information
Public title
Feasibility and efficacy of endoscopic laryngo-pharyngeal surgery(ELPS) and endoscopic submucosal dissection(ESD) for pharyngeal and laryngeal tumor
Acronym
Feasibility and efficacy of endoscopic treatment for pharyngeal and laryngeal tumor
Scientific Title
Feasibility and efficacy of endoscopic laryngo-pharyngeal surgery(ELPS) and endoscopic submucosal dissection(ESD) for pharyngeal and laryngeal tumor
Scientific Title:Acronym
Feasibility and efficacy of endoscopic treatment for pharyngeal and laryngeal tumor
Region
| Japan |
Condition
Condition
pharyngeal and laryngeal tumor
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Treatment outcomes of ESD and ELPS for pharyngeal and laryngeal tumor
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment outcomes of ESD and ELPS for pharyngeal and laryngeal tumor
Key secondary outcomes
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with endoscopic submucosal dissection or endoscopic laryngo-pharyngeal surgery for pharyngeal or esophageal tumor.
2) Patients consent to be included in the study based on his/her own free will after sufficient informing and understanding of the study.
Key exclusion criteria
1) Cases having difficulty in endoscopic approach
2) Cases with Performance Status 4
3) Cases with sever complication in other organs except original disease
4) Cases judged by principal investigator to be inadequate as subjects
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | HAYATO |
| Middle name | |
| Last name | YAMAGUCHI |
Organization
Tokyo Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
160-0023
Address
6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
hayato10@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | HAYATO |
| Middle name | |
| Last name | YAMAGUCHI |
Organization
Tokyo Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
160-0023
Address
6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
hayato10@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
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
Tokyo Medical University
Address
6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
Tel
03-3342-6111
hayato10@tokyo-med.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
| 2019 | Year | 07 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Unpublished
Management information
Registered date
| 2019 | Year | 07 | Month | 03 | Day |
Last modified on
| 2021 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042445
