UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060996 |
|---|---|
| Receipt number | R000068782 |
| Scientific Title | A Multicenter Retrospective Study of Endoscopic Resection for Superficial Cancer at the Hypopharyngeal Esophageal Transition Zone |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/19 20:17:34 |
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Basic information
Public title
A Multicenter Retrospective Study of Endoscopic Resection for Superficial Cancer at the Hypopharyngeal Esophageal Transition Zone
Acronym
HETZ Study
Scientific Title
A Multicenter Retrospective Study of Endoscopic Resection for Superficial Cancer at the Hypopharyngeal Esophageal Transition Zone
Scientific Title:Acronym
HETZ Study
Region
| Japan |
Condition
Condition
Hypopharyngeal cancer, Esophageal cancer
Classification by specialty
| Gastroenterology | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Superficial cervical esophageal cancer and superficial hypopharyngeal cancer extending into the hypopharyngeal esophageal transition zone are relatively rare, and sufficient data regarding treatment outcomes and complications of endoscopic resection have not yet been accumulated. The aim of this study is to clarify treatment outcomes and complications by collecting clinical data from patients who underwent endoscopic resection for these diseases across multiple institutions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival, recurrence-free survival, disease-free survival, and disease-specific survival
Key secondary outcomes
The associations of patient characteristics, disease stage, lesion-related factors, early treatment-related adverse events, post-treatment stricture, and the occurrence of metachronous multiple and synchronous cancers with survival outcomes and adverse event rates will be examined.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with superficial cancer of the cervical esophagus or the hypopharynx extending into hypopharynegal esophageal transition zone who underwent endoscopic resection.
2. Histopathologically diagnosed squamous cell carcinoma, including high-grade intraepithelial neoplasia and severe dysplasia.
3. Negative deep resection margin in the resected specimen.
4. No clinical evidence of lymph node metastasis.
5. Availability of intraoperative endoscopic images.
6. Availability of formalin-fixed, paraffin-embedded (FFPE) tissue sections of the tumor obtained at the time of endoscopic resection.
Key exclusion criteria
1. Presence of unresectable multiple primary cancers in the head and neck or esophageal region at the time of endoscopic resection.
2. Presence of unresectable synchronous primary cancer in other organs at the time of endoscopic resection.
3. Cases with extremely short follow-up periods or an excessive amount of missing data, making reliable analysis difficult.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yo |
| Middle name | |
| Last name | Kishimoto |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, JAPAN
TEL
+81-75-751-3346
y_kishimoto@ent.kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yo |
| Middle name | |
| Last name | Kishimoto |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, JAPAN
TEL
+81-75-751-3346
Homepage URL
y_kishimoto@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
Tel
075-366-7618
ethcom@kuhp.kyoto-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
| 2026 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 08 | Month | 05 | Day |
Date of IRB
| 1985 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2026 | Year | 03 | Month | 19 | Day |
Last modified on
| 2026 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068782
