Superficial pharyngeal neoplasms
Conditions
Interventions
None listed
Sponsors
NTT Medical Center Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection | — |
Secondary
| Measure | Time frame |
|---|---|
| En bloc resection rate / Procedure time / Submucosal dissection speed / Intraoperative adverse events / Postoperative adverse events | — |
Countries
Japan
Contacts
Public ContactHiroshi Yamazaki
NTT Medical Center Tokyo Department of Gastrointestinal Endoscopy
Outcome results
None listed