Image-guided maxillectomy

Intraoperative verification of maxillary malignancy resection with cone-beam computed tomography

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN14469511

Enrollment

Registered

2018-02-13

Start date

2017-01-01

Completion date

Unknown

Last updated

2019-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary sinus malignancies Ear, Nose and Throat Maxillary sinus malignancies

Interventions

This is a prospective study which has the character of an exploratory pilot study, establishing the implementation of CBCT in patients undergoing maxillectomy for malignant tumours. Patients with maxi

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 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) 3. The completeness of surgical resections are estimated based on remaining bonny anatomy of the maxilla visible in the intraoperative CBCT scan 4. Preoperatively planned and actually performed surgical resections are quantitatively compared by calculating “Sorensen-Dice coefficient” and the “Hausdorff distance” between corresponding bony structures	—

Measure

Time frame

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. 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) 3. The completeness of surgical resections are estimated based on remaining bonny anatomy of the maxilla visible in the intraoperative CBCT scan 4. Preoperatively planned and actually performed surgical resections are quantitatively compared by calculating “Sorensen-Dice coefficient” and the “Hausdorff distance” between corresponding bony structures

—

Secondary

Measure	Time frame
There are no secondary outcome measures.	—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026