C06.9 C10.9
Conditions
Interventions
Group 1: Cytological tumor swab in an outpatient setting
if cytology shows a positive finding (tumor cells), a panendoscopy + rapid section histology will be performed
if rapid section histology is positive, a transoral tumor resection in the same operation will be performed (intervention arm)
Group 2: Confirmation of clinical diagnosis by panendoscopy + biopsy
transoral tumor resection in a second operation if histology is positive (control arm)
Sponsors
Universitätsklinikum des SaarlandesKlinik für HNO-Heilkunde
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: cT1-2 squamous cell carcinoma of the oral cavity or the oropharynx (tonsil, base of tongue, soft palate); swab cytology feasible in an outpatient setting; planned surgical treatment; no necessarity of a plastic defect coverage by a free or pedicled flap transplant; signed informed consent; Age of 18 years or higher and unlimited legal capacity
Exclusion criteria
Exclusion criteria: Primary tumor in a region outside of the oral cavity or oropharynx; cT3 or higher staged Tumors; no clinical evidence for a malignant disease; swab cytology not feasible in an outpatient setting; no planned surgical treatment; necessarity of a plastic defect coverage with a free or pedicled flap transplant; lack of signed informed consent; age < 18 years or limited legal capacity; pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time span between clinical diagnosis and definitive surgical treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, progression free survival (5 years follow-up), whole time span of treament, diagnostic sensitivity of liquid-based cytology for the diagnosis of HNSCC | — |
Countries
Germany, Luxembourg
Contacts
Public ContactMaximilian Linxweiler
Universitätsklinikum des SaarlandesKlinik für HNO-Heilkunde
Outcome results
None listed