UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057805 |
|---|---|
| Receipt number | R000066064 |
| Scientific Title | An Exploratory Clinical Study on the Efficacy and Safety of a Peptide-Based Absorbable Topical Hemostatic Agent for the Prevention of Intractable Pharyngeal Ulcers Following Minimally Invasive Treatment of Superficial Pharyngeal Cancer |
| Date of disclosure of the study information | 2025/05/10 |
| Last modified on | 2025/05/08 22:40:18 |
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Basic information
Public title
"An Exploratory Clinical Study on the Efficacy and Safety of a Peptide-Based Absorbable Topical Hemostatic Agent for the Prevention of Intractable Pharyngeal Ulcers Following Minimally Invasive Treatment of Superficial Pharyngeal Cancer
Acronym
Pharyngeal ulcer prevention with PURESTAT
Scientific Title
An Exploratory Clinical Study on the Efficacy and Safety of a Peptide-Based Absorbable Topical Hemostatic Agent for the Prevention of Intractable Pharyngeal Ulcers Following Minimally Invasive Treatment of Superficial Pharyngeal Cancer
Scientific Title:Acronym
Pharyngeal Ulcer prevention with PURESTAT
Region
| Japan |
Condition
Condition
superficial pharyngeal cancer
Classification by specialty
| Gastroenterology | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study will assess the symptom improvement rate of dysphagia following the application of PURESTAT in patients with intractable pharyngeal ulcers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of dysphagia assessed by the Functional Outcome Swallowing Scale (FOSS) at 24 weeks following Endoscopic Submucosal Dissection (ESD), Endoscopic Laryngopharyngeal Surgery (ELPS), or Transoral Robotic Surgery (TORS)
Key secondary outcomes
everity of dysphagia (FOSS) at 12 weeks after ESD, ELPS, or TORS
Severity of dysphagia at each time point (assessed using the Functional Outcome Swallowing Scale [FOSS] and Common Terminology Criteria for Adverse Events [CTCAE, JCOG version])
Degree of pharyngeal pain (assessed using the Numerical Rating Scale [NRS])
Presence or absence of gastrostomy
Duration of fasting
Introduction of swallowing rehabilitation (yes/no)
Incidence of postoperative pneumonia
Proportion of cases in which a standard endoscope could not pass through the esophagus
Residual ulcer rate and incidence of scar contracture at 4, 12, and 24 weeks after ESD, ELPS, or TORS
Incidence of adverse events
Incidence of serious adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
An appropriate amount of the peptide-based absorbable topical hemostatic agent (PURESTAT) will be evenly applied to the ulcer base following ESD, ELPS, or TORS for pharyngeal tumors, with a maximum volume of 20 mL.
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Diagnosed with primary pharyngeal squamous cell carcinoma including high-grade dysplasia HGD or basaloid carcinoma by endoscopy or histopathology
2 Tumor is endoscopically confined to the epithelial EP or subepithelial SEP layer
3 No lymph node or distant metastasis on contrast-enhanced CT slice <=10 mm from neck to abdomen or PET-CT cN0M0 UICC TNM 8th ed Non-contrast CT allowed if renal dysfunction contrast allergy or asthma
4 ESD ELPS or TORS is planned for a lesion meeting at least one of the following
Expected resected specimen >=35 mm
Lesion developed after cervical radiotherapy
Residual or recurrent lesion post-RT or CRT for pharyngeal cancer
5 Single lesion in pharynx or esophagus or all other lesions <10 mm
6 Age 18 to 85 at informed consent
7 ECOG performance status 0 to 1
8 No prior surgery for laryngeal pharyngeal or esophageal cancer
9 CTCAE JCOG dysphagia grade <=2
10 Lab values within 90 days before registration
WBC >=2000 and <=12000 per mm3
Hemoglobin >=8.0 g per dL
Platelets >=100000 per mm3
Total bilirubin <=2.0 mg per dL
AST <=150 IU per L
ALT <=150 IU per L
Creatinine <=2.0 mg per dL
11 Written informed consent obtained
Secondary screening
12 Target lesion confined to pharynx completely resected by ESD ELPS or TORS and meets at least one of the following
Resected specimen >=35 mm
Lesion developed after cervical radiotherapy
Residual or recurrent lesion post-RT or CRT for pharyngeal cancer
Key exclusion criteria
1 Active multiple cancers including synchronous or metachronous cancers with disease-free interval less than 1 year
Exceptions include superficial pharyngeal cancer stage 0 esophageal cancer or completely resected cancers in the following stages
Gastric colon or rectal adenocarcinoma stage 0 to I
Breast cancer DCIS LCIS stage 0 IDC ILC Paget stage 0 to IIA
Endometrial adenocarcinoma stage I
Prostate cancer stage I to II
Cervical SCC stage 0
Thyroid cancer papillary or follicular stage I to III
Renal cell carcinoma clear cell or chromophobe type stage I
2 Lesion involving larynx
3 Systemic infection requiring treatment
4 Fever 38.0C or higher at axilla at provisional registration
5 Female patients who are pregnant possibly pregnant within 28 days postpartum or breastfeeding
6 Psychiatric illness or symptoms that make study participation difficult
7 Receiving continuous systemic corticosteroids or immunosuppressants oral or IV
8 Receiving inhaled corticosteroid therapy
9 Uncontrolled hypertension
10 Unstable angina within 3 weeks or history of myocardial infarction within 6 months
11 Respiratory disease requiring continuous oxygen therapy
12 History of allergy to peptide-based or protein-based agents
Target sample size
30
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
734-0037
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5537
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
734-0037
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5139
Homepage URL
beyan13@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
3-D Matrix, Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Clinical Research Support, Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
Tel
082-257-5555
yhiyama@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 | 05 | Month | 10 | 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
| 2025 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 08 | Day |
Last modified on
| 2025 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066064
