UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of swallowing function after reconstruction surgery for oral,orophayrngeal, and hypopharyngeal cancer using 320-Detector-Row Multislice CT.
Acronym	Evaluation of swallowing function after surgery for oral,orophayrngeal, and hypopharyngeal cancer using multislice CT.
Scientific Title	Evaluation of swallowing function after reconstruction surgery for oral,orophayrngeal, and hypopharyngeal cancer using 320-Detector-Row Multislice CT.
Scientific Title:Acronym	Evaluation of swallowing function after surgery for oral,orophayrngeal, and hypopharyngeal cancer using multislice CT.
Region	Japan

Condition
Condition	orophayrngeal cancer
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the swallowing movement of the patient who received reconstruction surgery for oropharyngeal cancer using multislice CT.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Movement of pharyngeal wall and hyoid bone, larynx during swallow.
Key secondary outcomes	Pharyngeal constriction ratio, Bolus residual ratio, Oral-pharyngeal transit time, MTF score, %LE, Swallowing pressure of pharynx, AsR score,

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	Diagnosis
Type of intervention	Other
Interventions/Control_1	Administer multislice CT at frequent checkup, once per person
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	(1) squamous cell carcinoma in head and neck region (2) primary site is oropharynx (3) received reconstruction surgery for oropahryngeal cancer between April 1, 2000 and March 31, 2016 at Nagoya university hospital. (4) not received Radiation therapy before or after surgery (5) available for clinical records (6) not received Radiation therapy for another head and neck cancer (7) not received radiation therapy for other cancer (8) not have simultaneous or metachronous head and neck cancer
Key exclusion criteria	(1) minority (2) have systemic infection (3) have simultaneous or metachronous head and neck cancer (4) fever over 38 degree (5) pregnant (6) have mental disease, and can not decision making (7) have heart disease that not cured or during treatment (8) reject to using clinical records
Target sample size	15

Research contact person
Name of lead principal investigator	1st name takashi Middle name Last name maruo
Organization	Nagoya university
Division name	Otorhinolaryngology
Zip code	4668560
Address	Tsurumai tyou 65, shouwa ward, nagoya city, aichi prefecture, japan
TEL	052-744-2323
Email	yasushif@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name takashi Middle name Last name maruo
Organization	Nagoya university hospital
Division name	Otorhinolaryngology
Zip code	466-8560
Address	Tsurumai tyou 65, shouwa ward, nagoya city, aichi prefecture, japan
TEL	052-744-2323
Homepage URL
Email	tmaruo@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya university
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagoya university hospital
Address	Tsurumai tyou 65, shouwa ward, nagoya city, aichi prefecture, japan
Tel	052-744-2323
Email	tmaruo@med.nagoya-u.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 10 Month 31 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	2017 Year 07 Month 30 Day
Date of IRB	2017 Year 09 Month 16 Day
Anticipated trial start date	2017 Year 12 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 10 Month 06 Day
Last modified on	2021 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033659