UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056620 |
|---|---|
| Receipt number | R000064713 |
| Scientific Title | A Single-Center Prospective Study on the Diagnostic Accuracy of Narrow-Band Imaging and Iodine Staining in Defining Lesion Extent During Endoscopic Treatment of Pharyngo-Laryngeal and Esophageal Cancer |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2025/01/03 17:02:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Single-Center Prospective Study on the Diagnostic Accuracy of Narrow-Band Imaging and Iodine Staining in Defining Lesion Extent During Endoscopic Treatment of Pharyngo-Laryngeal and Esophageal Cancer
Acronym
Evaluation of the Utility of NBI Versus Iodine Staining in Determining Lesion Extent for Superficial Pharyngo-Laryngeal and Esophageal Cancer
Scientific Title
A Single-Center Prospective Study on the Diagnostic Accuracy of Narrow-Band Imaging and Iodine Staining in Defining Lesion Extent During Endoscopic Treatment of Pharyngo-Laryngeal and Esophageal Cancer
Scientific Title:Acronym
Evaluation of the Utility of NBI Versus Iodine Staining in Determining Lesion Extent for Superficial Pharyngo-Laryngeal and Esophageal Cancer
Region
| Japan |
Condition
Condition
Superficial Pharyngo-Laryngeal and Esophageal Cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
n the endoscopic treatment of pharyngo-laryngeal and esophageal squamous cell carcinoma, iodine staining is commonly used to determine the extent of the lesion. While iodine staining enables clear visualization of lesion boundaries, it is associated with significant patient burden, as approximately half of the patients experience symptoms such as sore throat, chest pain, or discomfort after the procedure.
Recently, there have been rapid advancements in equipment-based image-enhanced endoscopy (IEE) technologies, including digital methods that process optical information obtained under white light and optical digital methods that enhance images using light other than white light. Among these, narrow-band imaging (NBI) is a notable technique that uses narrow-band light to emphasize the capillary structures and microvascular patterns on the mucosal surface. This method allows for the detection of superficial pharyngo-laryngeal and esophageal cancers that are difficult to identify with conventional endoscopy.
Since NBI does not require the use of staining agents, the patient burden is comparable to that of standard endoscopic observation. Therefore, we conducted a single-center prospective study to compare the diagnostic utility of NBI and iodine staining in determining the extent of pharyngo-laryngeal and esophageal squamous cell carcinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Utility of NBI and Iodine Staining in Determining Lesion Extent for Pharyngo-Laryngeal and Esophageal Squamous Cell Carcinoma
Key secondary outcomes
Clinicopathological Characteristics of Lesions with Discrepancies in Extent Diagnosis Between Iodine Staining and NBI (Gender, Age, Medical History, Lifestyle History, Lesion Size, Lesion Depth, and Condition of the Surrounding Mucosa)
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
Patients scheduled for endoscopic resection
Esophageal squamous cell carcinoma
Superficial pharyngo-laryngeal cancer
Aged 20 years or older at the time of enrollment
Written informed consent obtained from the patient
Key exclusion criteria
Presence of iodine allergy
Inability to complete EMR/ESD or ELPS for the target lesion
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shiro |
| Middle name | |
| Last name | Oka |
Organization
Hiroshima University Hospital
Division name
Department of gastroenterology
Zip code
734-8553
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5193
oka4683@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Urabe |
Organization
Hiroshima University Hospital
Division name
Department of gastroenterology
Zip code
734-8553
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5193
Homepage URL
beyan13@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
Tel
082-257-5193
beyan13@hiroshima-u.ac.jp
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
| 2025 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
200
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
During endoscopic treatment of pharyngo-laryngeal and esophageal squamous cell carcinoma, lesion boundaries are first marked based on NBI observation. Iodine staining is then performed, and if the lesion boundaries observed after iodine staining differ from those marked during NBI observation, the boundaries are re-marked based on the iodine-stained observation. Following marking, the lesion is endoscopically resected, ensuring that the resection includes the outermost marking points.
(Under standard endoscopic treatment protocols, the process involves: 1) determining the lesion extent using NBI observation, 2) determining the lesion extent after iodine staining, and 3) marking the lesion boundaries. Although this study differs from standard procedures in terms of the sequence of steps, no new therapeutic interventions are introduced. If the lesion boundaries observed with NBI and iodine staining are identical, additional marking after iodine staining is not performed.)
Post-resection, the specimen is stretched and mounted on a Styrofoam board, photographed, and the lesion extent is pathologically evaluated based on the photograph. The accuracy of the markings, determined using either NBI or iodine staining, in indicating the true lesion extent is then assessed.
Management information
Registered date
| 2025 | Year | 01 | Month | 03 | Day |
Last modified on
| 2025 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064713
| Research Plan | |
|---|---|
| Registered date | File name |
| 2025/07/06 | 1.研究計画書 範囲診断NBI vs ヨード 新様式 研究責任者変更後.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/07/07 | 研究症例データ仕様書.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2025/07/07 | 研究症例データ.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/64713
