UMIN-CTR Clinical Trial

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
Email	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
Email	hayato10@tokyo-med.ac.jp

Sponsor
Institute	Tokyo Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042445