superficial pharyngeal carcinoma
Conditions
Interventions
Peptide-derived absorbent hemostatic material (PureStat) is applied evenly and appropriately to the ulcer base immediately after ESD/ELPS/TORS for superficial cancer of the pharynx, with an upper limi
Sponsors
Oka Shiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Endoscopically or histologically diagnosed primary squamous cell carcinoma (including HGD) or basal cell carcinoma of the pharynx. 2. Endoscopic diagnosis of tumor wall depth as either intraepithelial (EP) or subepithelial (SEP). 3. No evidence of lymph node or distant metastasis on cervical to abdominal contrast-enhanced CT or PET-CT. Simple CT is acceptable in the presence of renal dysfunction, contrast allergy, or bronchial asthma. 4. ESD, ELPS, or TORS is planned for one or more of the following lesions - The lesion is expected to have a resected specimen with a diameter greater than or equal to 35 mm. - Lesions with a history of cervical irradiation and arising from the background mucosa. - Recurrent lesions after RT/CRT for pharyngeal carcinoma 5. Through the pharynx and esophagus, "single lesion" or "multiple lesions, but all secondary lesions are less than 10 mm except one lesion (main lesion) to be treated". 6. Age on the date consent is obtained is at least 18 years old and less than 85 years old. 7. Performance status (PS) is 0-1 according to ECOG criteria. 8. No previous surgery for cancer of the pharynx or esophagus. 9. CTCAE JCOG dysphagia =2,000/mm3 and =8.0 g/dL (3) Platelet count >=1,0000 / mm3 (4) Total bilirubin <=2.0 mg/dL (5) AST(GOT) <=150 IU/L (6) ALT(GPT) <=150 IU/L (7) Serum creatinine <=2.0 mg/dL 11. Written consent to participate in this study has been obtained from the patient. 12. The lesion is confined to the pharynx, and resection of the lesion has been completed by ESD, ELPS, or TORS, and one or more of the following apply - The long diameter of the resected specimen is more than 35 mm - Lesions arising from a mucosal background with a history of neck radiation have been resected - Recurrent lesions that occurred after RT/CRT for pharyngeal cancer were resected
Exclusion criteria
Exclusion criteria: 1. Active overlapping cancers. 2. The distribution of the lesion extends into the larynx. 3. Infections requiring systemic treatment. 4. Fever of 38 degrees or higher at axillary temperature at the time of provisional registration. 5. Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding. 6. Patients with psychiatric disorders or psychiatric symptoms that make it difficult for them to participate in the study. 7. Receiving continuous systemic administration of steroids or other immunosuppressive agents. 8. Receiving a steroid combination inhaler. 9. Complicated by poorly controlled hypertension. 10. Complicated unstable angina (angina with onset or worsening attacks within the last 3 weeks) or history of myocardial infarction within 6 months. 11. Complicated respiratory disease requiring continuous oxygen administration. 12. History of hypersensitivity to peptide or protein preparations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degree of dysphagia at 24 weeks after ESD/ELPS/TORS (FOSS) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Degree of dysphagia at 12 weeks after ESD/ELPS/TORS (FOSS) - Degree of dysphagia at each time point (FOSS, CTCAE JCOG) - Degree of sore throat (Numerical Rating Scale; NRS) - Gastrostomy - Duration of fasting - Swallowing rehabilitation - Incidence of postoperative pneumonia - Rate of cases in which a conventional scope cannot be passed through the esophagus - Rate of residual ulceration and scar contracture at 4, 12, and 24 weeks after ESD/ELPS/TORS - Incidence of adverse events - Incidence of serious adverse events | — |
Contacts
Public ContactYuji Urabe
Hiroshima University Hospital
Outcome results
None listed