UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045230 |
|---|---|
| Receipt number | R000051672 |
| Scientific Title | Efficacy of Iodine staining surveillance of the pharynx during endoscopic resection for patients with pharyngeal cancer - a multicenter prospective study. |
| Date of disclosure of the study information | 2021/08/23 |
| Last modified on | 2021/08/23 16:47:08 |
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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
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
y.nishimura0503@gmail.com
Sponsor or person
Institute
Hokkaido medical center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051672
