Image guided endoscopic sinus surgery

Intraoperative verification of paranasal sinus malignancy resection with cone-beam computed tomography

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON20396

Enrollment

Registered

2017-07-06

Start date

2017-08-31

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

paranasal sinus malignancy, sinus cancer

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: • Primary tumours of the paranasal sinus (T1-T4a for non-melanomas and T3-T4a for melanomas), confirmed by biopsy. Recurrent cases are also eligible. • Any lymph node status • M0 • Treatment plan approved by the multidisciplinary head and neck oncology board of the AvL. • Age over 18-years old • No contraindications to general anesthesia • Informed consent, written and signed

Exclusion criteria

Exclusion criteria: • Unresectable tumours of the paranasal sinus • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol • Pregnancy

Design outcomes

Primary

Measure	Time frame
The main parameter of this pilot study is the technical success of implementing CBCT during endoscopic sinus surgery as an additional tool for the control of the resection. Operating time will be recorded and the mean duration of the procedure will be calculated. Assessment of the possible residual tumour volume will be also performed based on the intraoperative CBCT, as well as comparison to the planned resection volume as calculated in the preoperative imaging planning. The quality of CBCT and MRI scan matching will also be evaluated. No correlation to clinicopathological parameters will be established in this study.	—

Measure

Time frame

The main parameter of this pilot study is the technical success of implementing CBCT during endoscopic sinus surgery as an additional tool for the control of the resection. Operating time will be recorded and the mean duration of the procedure will be calculated. Assessment of the possible residual tumour volume will be also performed based on the intraoperative CBCT, as well as comparison to the planned resection volume as calculated in the preoperative imaging planning. The quality of CBCT and MRI scan matching will also be evaluated. No correlation to clinicopathological parameters will be established in this study.

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Contacts

Public ContactBaris Karakullukçu

Department of Head and Neck Oncology and Surgery

b.karakullukcu@nki.nl020-5122550

Outcome results