UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of false negative lesions in mucosal sites of the head and neck in the preoperative evaluation of transoral endoscopy with the NBI
Title of the study (Brief title)	Study of false negative lesions in mucosal sites of the head and neck in the preoperative evaluation of transoral endoscopy with the NBI
Region	Japan

Condition
Condition	Pharyngeal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the frequency of false negative lesions in the preoperative evaluation of transoral endoscopy with the NBI for patients with pharyngeal cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To investigate the rate of false negative lesions between preoperative examination and lugol chromoendoscopy using curved laryngoscope in surgery
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(i) no evidence of invasion to the muscle layer on the basis of white light endoscopy. (ii) no lymph node metastasis as shown on computed tomographic examinations before treatment. (iii) a histological diagnosis of squamous cell carcinoma, (iv) an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-2 (v) adequate major organ functions (vi) serious complications such as active infectious disease and serious heart disease.
Key exclusion criteria	Psychiatric disease that is inappropriate for entry into this study
Target sample size	25

Research contact person
Name of lead principal investigator	Hisashi Doyama
Organization	Ishikawa Prefectural Central Hospital
Division name	Department of Gastroenterology
Address	2-1 Kuratukihigashi, Kanazawa-shi, Ishikawa
TEL	076-237-8211
Email	doyama.134@ipch.jp

Public contact
Name of contact person	Kunihiro Tsuji
Organization	Ishikawa Prefectural Central Hospital
Division name	Department of Gastroenterology
Address	2-1 Kuratukihigashi, Kanazawa-shi, Ishikawa
TEL	076-237-8211
Homepage URL
Email	kt98052@yahoo.co.jp

Sponsor
Institute	Department of Gastroenterology, Ishikawa Prefectural Central Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2014 Year 07 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 03 Day
Anticipated trial start date	2014 Year 07 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The aim of this study was to evaluate the false negative pharyngeal cancers in the preoperative endoscopic examination.

Management information
Registered date	2014 Year 07 Month 24 Day
Last modified on	2019 Year 01 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015780