臨床研究等提出・公開システム

Date of registration	June. 25, 2026
Last modified on	June. 25, 2026
Trial ID	jRCT1060260034

Scientific Title	Exploratory Interventional Study on the Usefulness of Straw-Assisted Pyriform Sinus Observation During Transnasal Endoscopy in Healthy Volunteers
Public Title	Evaluation of Pyriform Sinus Observation Using a Straw

Contact for Scientific Queries	Name	Hamamoto Takao
	Affiliation	Hiroshima University Hospital
	Address	1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima
	Telephone	+81-82-257-5252
	E-mail	takao0320@hiroshima-u.ac.jp
Contact for Public Queries	Name	Hamamoto Takao
	Affiliation	Hiroshima University Hospital
	Address	1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima
	Telephone	+81-82-257-5252
	E-mail	takao0320@hiroshima-u.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		June. 25, 2026
Target sample size		24
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1. Healthy individuals aged 18 to 65 years at the time of informed consent 2. Individuals who have received sufficient explanation of the study and have provided written informed consent 3. Individuals deemed by the principal investigator or co-investigator to be able to safely undergo transnasal endoscopy 4. Individuals who understand the expiratory maneuver using a straw and are judged capable of performing it
	Exclusion Criteria	1. Individuals prone to epistaxis 2. Individuals deemed difficult to undergo transnasal endoscope insertion due to significant nasal cavity stenosis, nasal septum deviation, or similar conditions 3. Individuals in whom a strong gag reflex is anticipated and continuation of the examination is deemed difficult 4. Individuals unable to safely perform the expiratory maneuver using a straw due to respiratory diseases or other conditions 5. Individuals with symptoms of acute upper respiratory tract inflammation 6. Individuals who are pregnant, possibly pregnant, or breastfeeding 7. Individuals whom the principal investigator or co-investigator deems to be in a vulnerable position as research subjects, such as those in a teacher-student, supervisor-subordinate, or supervising physician-trainee relationship with the investigator 8. Individuals otherwise deemed inappropriate by the principal investigator or co-investigator
	Age Minimum	18age old over
	Age Maximum	65age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Healthy Volunteers
Intervention(s)		In this study, transnasal endoscopic observation will be performed under the following four conditions: 1. Conventional observation method 2. Valsalva method 3. MK method 4. Straw method Conventional observation method (neck rotation + phonation) After instructing the subject to rotate the neck, the subject is asked to vocalize "E," and observation of the pyriform sinus is performed. Valsalva method (neck rotation + breath-holding) After instructing the subject to rotate the neck, the subject is asked to perform breath-holding or an expiratory maneuver with awareness of expanding the pharyngeal cavity, and observation of the pyriform sinus is performed. MK method The subject is instructed to flex the neck forward, then asked to perform neck rotation along with breath-holding or an expiratory maneuver with awareness of expanding the pharyngeal cavity, and observation of the pyriform sinus is performed. Straw-assisted observation method The subject is instructed to hold a straw with the lips, and after rotating the neck, the subject performs a controlled expiratory maneuver through the straw while observation of the pyriform sinus is performed. In this study, a standard straight plastic straw with a diameter of 3.5 mm and a length of 21 cm will be used. Blinding of study subjects will not be performed. Video assessments will be conducted under blinded conditions by an independent evaluator, with videos edited and anonymized as much as possible to make the observation method difficult to identify.
Primary Outcome(s)		The primary objective is to exploratorily investigate whether the straw method is non-inferior to the MK method with respect to the pyriform sinus observation score. For each observation condition, the right and left pyriform sinuses are each evaluated on a scale of 0 to 3 points, and the total score (0 to 6 points) is defined as the bilateral pyriform sinus observation total score. The primary endpoint is the difference in the bilateral pyriform sinus observation total score between the straw method and the MK method.
Secondary Outcome(s)		1. Visibility across the four conditions (bilateral pyriform sinus observation total score) 2. Procedure duration 3. Number of instructions given 4. Number of retries 5. Subject burden assessment (VAS) 6. Inter-rater agreement

Primary Sponsor	none

Name of Certified Review Board	Ethical Committee for Clinical Research of Hiroshima University
Address	1-2-3 kasumi, Minami-ku, Hiroshima, Hiroshima, Hiroshima
Telephone	+81-82-257-1947
E-Mail	iryo-sinsa@office.hiroshima-u.ac.jp
Approval Status	Approval
Date of approval	June. 15, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none