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

Centre Leon Berard53 enrolled

Overview

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.

* 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

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Upper Digestive Tract Cancer

Interventions

Therapeutic assessment -Radio-surgical guidance.PROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Centre Léon Bérard Service de Chirurgie-Stomatologie

Lyon, Cedex 08, France

CHU Hôtel-Dieu Service d'Odontologie

Clermont-Ferrand, France

Hospices Civils de Lyon Service de Consultations et Traitements Dentaires

Lyon, France

Centre Hospitalier Lyon Sud Service de Stomatologie et Chirurgie Maxillo-Faciale

Pierre-Bénite, France

Outcomes

Primary Outcomes

Accuracy of implants insertion, radio-surgical guidance.

Time frame: 8 months after inclusion