Image-guided maxillectomy
Not Applicable
Completed
- Conditions
- Maxillary sinus malignanciesEar, Nose and Throat
- Registration Number
- ISRCTN14469511
- Lead Sponsor
- The Netherland Cancer Institute Antoni van Leeuwenhoek Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
1. Primary tumours of the maxilla (T1-T4a for non-melanomas and T3-T4a for melanomas), confirmed by biopsy. Recurrent cases are also eligible.
2. Any lymph node status
3. M0
4. Treatment plan approved by the multidisciplinary head and neck oncology meeting of the AvL
5. Aged over 18-years old
6. No contraindications to general anesthesia
7. Informed consent, written and signed
Exclusion Criteria
1. Unresectable tumours of the maxillary sinus
2. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
3. Pregnancy
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Feasibility of utilising CBCT as an imaging tool for intraoperative verification of maxillary malignant tumours is evaluated by comparing intraoperative assessment of surgical resections, based on quantitative comparison of preoperatively planned and actually resected bone volumes, with the pathology.<br> 2. Mean times of the procedure are measured as the complete surgical overhead caused by study-related steps (this includes sterile intraoperative cone-beam CT scan and quantitative evaluation of the results)<br> 3. The completeness of surgical resections are estimated based on remaining bonny anatomy of the maxilla visible in the intraoperative CBCT scan<br> 4. Preoperatively planned and actually performed surgical resections are quantitatively compared by calculating Sorensen-Dice coefficient” and the Hausdorff distance” between corresponding bony structures<br>
- Secondary Outcome Measures
Name Time Method There are no secondary outcome measures.