UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of Iodine staining surveillance of the pharynx during endoscopic resection for patients with pharyngeal cancer - a multicenter prospective study.
Acronym	iSper study
Scientific Title	Efficacy of Iodine staining surveillance of the pharynx during endoscopic resection for patients with pharyngeal cancer - a multicenter prospective study.
Scientific Title:Acronym	iSper study
Region	Japan

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

Objectives
Narrative objectives1	To clarify the detection rate of preoperative unpointed lesions (secondary lesions) by pharyngeal iodine staining surveillance during ER of superficial pharyngeal cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection rate of new superficial pharyngeal cancer by iodine staining during ER under general anesthesia
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	(1) Those who fall under the above-mentioned subjects and perform pharyngeal iodine staining for the purpose of identifying the lesion area at the time of ER in daily medical care. (2) Those whose cancer invasion depth is assumed to remain in the subepithelial layer (3) Those who have received sufficient explanation before participating in this research, and have obtained their free willing consent to participate in this research after sufficient understanding.
Key exclusion criteria	(1) Those who cannot do ER or biopsy (2) Those who are allergic to iodine (3) Person after total laryngectomy (4) Cases of residual recurrence after irradiation (5) Underage patients (under 20 years old) (6) In addition, those who the principal investigator deems inappropriate as research subjects
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Yuichi Middle name Last name Shimizu
Organization	Hokkaido medical center
Division name	Gastroenterology
Zip code	0630005
Address	5-7-1-1,Yamanote,Nishi-ku,Sapporo,Japan
TEL	011-611-8111
Email	yuichi0996@gmail.com

Public contact
Name of contact person	1st name Yusuke Middle name Last name Nishimura
Organization	Hokkaido University Hospital
Division name	Gastroenterology
Zip code	0608648
Address	Kita-14,Nishi-5,Kita-ku,Sapporo,Japan
TEL	011-716-1161
Homepage URL
Email	y.nishimura0503@gmail.com

Sponsor
Institute	Hokkaido medical center
Institute
Department

Funding Source
Organization	Hokkaido medical center
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	Hokkaido medical center
Address	5-7-1-1,Yamanote,Nishi-ku,Sapporo,Japan
Tel	011-611-8111
Email	yuichi0996@gmail.com

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	2021 Year 08 Month 23 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	2020 Year 12 Month 18 Day
Date of IRB	2020 Year 12 Month 18 Day
Anticipated trial start date	2020 Year 12 Month 18 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Before treatment, the entire pharyngeal mucosa was thoroughly washed with running water, NBI observation was performed, and then iodine staining surveillance was performed (under general anesthesia). Lesions with strong suspicion of cancer (clear iodine unstained with a size of 5 mm or more and positive Pink color sign) or lesions with strong suspicion of neoplastic lesions and cancer cannot be ruled out (size 5 mm or more) If a clear iodine stain and Pink color sign negative) are observed, the treatment is the same as in normal medical practice, that is, combined resection at the operator's discretion, or cauterization by argon plasma coagulation (APC) (biopsy is also performed). will be done. Also record whether these lesions were recognized as brownish areas by NBI observation. The diagnosis name, treatment method, presence / absence of accessory lesions and diagnosis, and information on adverse events during and after treatment are described in the CRF.After the pathological diagnosis, the histopathological diagnosis of each of the main lesion and the sub-lesion is described in the CRF.Central pathology is determined by the Pathology Department of Sapporo Kosei Hospital. Final analysis at Hokkaido University Hospital, iodine staining We will analyze the detection rate of cancer and the detection rate of neoplastic lesions.

Management information
Registered date	2021 Year 08 Month 23 Day
Last modified on	2021 Year 08 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051672