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

Léon Bérard Center

Status

Terminated

Conditions

Upper Digestive Tract Cancer

Treatments

Procedure: Therapeutic assessment -Radio-surgical guidance.

Study type

Interventional

Funder types

Other

Identifiers

NCT00925509

ET2006-032

CPP 07/033 [UBET83]

Details and patient eligibility

About

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.

Full description

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

Enrollment

53 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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