Clinical trial NCT00925509: Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts
Official title: Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Upper Digestive Tract Cancer
Keywords: 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
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: French Academic Institution, Financial support: PHRC 2007
First posted: 2009-06-22
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: * 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

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of implants insertion, radio-surgical guidance.
timeFrame: 8 months after inclusion
Secondary outcomes:
measure: Accuracy of inserting implants
timeFrame: 16 months after inclusion
measure: Delay of mucous healing
timeFrame: 16 months after inclusion
measure: Estimation of the prosthetic function
timeFrame: 16 months after inclusion
measure: Osteonecrosis rate after radiation with traumatic etiology due to implantation
timeFrame: 16 months after inclusion
measure: Implant rate
timeFrame: 16 months after inclusion
measure: Post surgical therapeutic success after 1 year
timeFrame: after 1 year
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard Service de Chirurgie-Stomatologie
state: Cedex 08
city: Clermont-ferrand
country: France
facility: CHU Hôtel-Dieu Service d'Odontologie
city: Lyon
country: France
facility: Hospices Civils de Lyon Service de Consultations et Traitements Dentaires
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud Service de Stomatologie et Chirurgie Maxillo-Faciale
Study officials:
affiliation: Centre Leon Berard
name: Anne-Gaëlle BODARD, MD
role: PRINCIPAL_INVESTIGATOR
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