UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060717 |
|---|---|
| Receipt number | R000068654 |
| Scientific Title | Prospective Study on Pharyngeal Endoscopic Submucosal Dissection Using a New Slim Scope EG-840TP |
| Date of disclosure of the study information | 2026/02/21 |
| Last modified on | 2026/02/20 20:06:41 |
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Basic information
Public title
Prospective Study on Pharyngeal Endoscopic Submucosal Dissection Using a New Slim Scope EG-840TP
Acronym
Study on pharyngeal ESD Using a New Thin Scope
Scientific Title
Prospective Study on Pharyngeal Endoscopic Submucosal Dissection Using a New Slim Scope EG-840TP
Scientific Title:Acronym
EG840TP-PESD study
Region
| Japan |
Condition
Condition
Superficial pharyngeal neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of Pharyngeal ESD with EG-840TP.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
R0 resection
Key secondary outcomes
En bloc resection rate / Procedure time / Submucosal dissection speed / Intraoperative adverse events / Postoperative adverse events
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 who meet all of the following inclusion criteria and do not meet any of the exclusion criteria are considered eligible for enrollment.
Patients diagnosed with a pharyngeal lesion by endoscopy, with histopathological confirmation of squamous cell carcinoma (SCC) or epithelial dysplasia on biopsy.
Predicted depth of invasion on detailed endoscopic assessment is epithelial layer (EP) or superficial subepithelial layer (SEP).
No lymph node or distant metastasis confirmed by whole-body CT.
No prior history of pharyngeal surgery or radiation therapy.
All of the following conditions must be met:
Age over 20 years at the time of enrollment.
ECOG performance status (PS) of 0 or 1.
Laboratory values obtained within 30 days prior to enrollment meet all of the following criteria
(and no blood transfusion within 14 days prior to the laboratory testing used for eligibility):
Hemoglobin over 9 g/dL
Platelets over 100,000 / mm3
AST/ALT under 100 U/L
Serum creatinine under 2.0 mg/dL
Ability to be followed for at least 14 days after treatment.
Written informed consent for study participation has been obtained.
Key exclusion criteria
Patients with bilateral hypopharyngeal lesions.
Women who are pregnant, possibly pregnant, or breastfeeding.
Patients with psychiatric disorders that prevent adequate understanding or cooperation with the study.
Patients with a history of myocardial infarction or unstable angina within the past 3 months.
Patients with blood coagulation disorders, regardless of the use of antithrombotic agents.
Patients with active bacterial or fungal infections (defined as having a fever over38.5degrees and radiological or microbiological evidence of infection).
Patients with respiratory diseases requiring continuous oxygen therapy.
Patients with uncontrolled hypertension.
Any patient deemed inappropriate for participation in this study at the discretion of the attending physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamazaki |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastrointestinal Endoscopy
Zip code
141-0022
Address
5-9-22Higashi Gotanda, Shinagawa, Tokyo
TEL
+818066291640
hiroyama90@hotmail.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamazaki |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastrointestinal Endoscopy
Zip code
141-0022
Address
5-9-22Higashi Gotanda, Shinagawa, Tokyo
TEL
+818066291640
Homepage URL
hiroyama90@hotmail.com
Sponsor or person
Institute
NTT Medical Center Tokyo
Institute
Department
Personal name
Hiroshi Yamazaki
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NTT Medical Center Tokyo
Address
5-9-22Higashi Gotanda, Shinagawa, Tokyo
Tel
0334486111
hiroyama90@hotmail.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
Tokyo
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 21 | 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
20
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
| 2024 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 02 | Month | 20 | Day |
Last modified on
| 2026 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068654
