Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts (ATIM)
|Upper Digestive Tract Cancer||Procedure: Therapeutic assessment -Radio-surgical guidance.|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts|
- Accuracy of implants insertion, radio-surgical guidance. [ Time Frame: 8 months after inclusion ]
- Accuracy of inserting implants [ Time Frame: 16 months after inclusion ]
- Delay of mucous healing [ Time Frame: 16 months after inclusion ]
- Estimation of the prosthetic function [ Time Frame: 16 months after inclusion ]
- Osteonecrosis rate after radiation with traumatic etiology due to implantation [ Time Frame: 16 months after inclusion ]
- Implant rate [ Time Frame: 16 months after inclusion ]
- Post surgical therapeutic success after 1 year [ Time Frame: after 1 year ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925509
|Centre Léon Bérard Service de Chirurgie-Stomatologie|
|Lyon, Cedex 08, France, 69373|
|CHU Hôtel-Dieu Service d'Odontologie|
|Clermont-ferrand, France, 63 000|
|Hospices Civils de Lyon Service de Consultations et Traitements Dentaires|
|Lyon, France, 69007|
|Centre Hospitalier Lyon Sud Service de Stomatologie et Chirurgie Maxillo-Faciale|
|Pierre Benite, France, 69495|
|Principal Investigator:||Anne-Gaëlle BODARD, MD||Centre Leon Berard|