UMIN-CTR Clinical Trial

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

Pharyngeal cancer

Classification by specialty

Gastroenterology

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Detection rate of new superficial pharyngeal cancer by iodine staining during ER under general anesthesia

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Hokkaido medical center

Institute

Department

Personal name

Organization

Hokkaido medical center

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Hokkaido medical center

Address

5-7-1-1,Yamanote,Nishi-ku,Sapporo,Japan

Tel

011-611-8111

Email

yuichi0996@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

08

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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