Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts

Study Overview
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Brief Summary
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Aero digestive Cancer patients treated by external head and neck radiotherapy and/or by curie-therapy and/or mandible reconstruction by microanastomosed fibula flaps. The purpose of the study is to Investigate the accuracy of implants insertion in the anteroposterior way, using radiosurgical guidance.

Detailed Description
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Investigate the accuracy of inserting implants in the vertical way and in angulation, on irradiated native mandible or on microanastomosed fibula flaps Investigate the accuracy of inserting implants in the anteroposterior way, in the vertical way and in angulation for all the involved patients (meaning on irradiated native mandible or on microanastomosed fibula flaps) Investigate the delay of mucous healing Estimate the prosthetic function Evaluate the osteonecrosis rate after radiation with traumatic etiology due to implantation Estimate the implant rate due to minimally invasive flaps Estimate the implant rate due to pure trans mucosa way Estimate the post surgical therapeutic success after 1 year

Official Title
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Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts

Conditions
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Upper Digestive Tract Cancer

Intervention / Treatment
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* Procedure: Therapeutic assessment -Radio-surgical guidance.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 18 Performance status over 70 Histological evidence of upper digestive tract cancer History of cranial / facial radiotherapy or brachytherapy and/or microvascular fibula transfer. Bone volume sufficient to support an implant. Mandatory affiliation with a social security system Written, voluntary, informed consent Exclusion Criteria: Patient with evolutive malignant disease Contraindication to general anesthesia Concurrent disease contra-indicating implant surgery (risk of infectious endocarditis, uncontrolled diabetes, HIV, evolutive neoplasia…) Patient enrolled in another clinical trial including chemotherapy Pregnant or lactating woman Anticipation of an impossible follow-up Patient deprived of freedom

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Therapeutic assessment -Radio-surgical guidance.|The first steps of the procedure include the production of a radiosurgical guide and the preparation of a mask in order to allow precise, non invasive repositioning of the guide. Secondarily, the patient undergoes a CT-scan with the mask on and the radiosurgical guide in place. This provisional scan is used for preimplantation evaluation and drilling of the guide hole. Under general anaesthesia, the mask is placed on the patient and the guide is fixed to the mask. A hole is drilled with a burr in the mandible through the hole in the guide. Implants are placed and the guide and mask are removed. A second, post-implantation CT-scan is planned 3 months after implantation. Comparison of pre- and post-implantation CT-scans allows to evaluate the precision of the placement.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of implants insertion, radio-surgical guidance. |  | 8 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of inserting implants |  | 16 months after inclusion | 
| Delay of mucous healing |  | 16 months after inclusion | 
| Estimation of the prosthetic function |  | 16 months after inclusion | 
| Osteonecrosis rate after radiation with traumatic etiology due to implantation |  | 16 months after inclusion | 
| Implant rate |  | 16 months after inclusion | 
| Post surgical therapeutic success after 1 year |  | after 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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upper digestive tract cancer, implants, implants insertion, radio-surgical guidance, accuracy of implants insertion, cranial/facial radiotherapy or brachytherapy and/or microvascular fibula transfer., Bone volume sufficient to support an implant