Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts
NCT ID: NCT00925509
Last Updated: 2011-06-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
53 participants
Study Classification
INTERVENTIONAL
Study Start Date
2007-09-30
Study Completion Date
2011-12-31
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.
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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
* 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
Conditions
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Upper Digestive Tract Cancer
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Interventions
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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.
Intervention Type
PROCEDURE
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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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French Academic Institution, Financial support: PHRC 2007
UNKNOWN
Sponsor Role
collaborator
Centre Leon Berard
OTHER
Sponsor Role
lead
Responsible Party
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Unité de Biostatistiques et Evaluation des Thérapeutiques
Principal Investigators
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Anne-Gaëlle BODARD, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
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Centre Léon Bérard Service de Chirurgie-Stomatologie
Lyon, Cedex 08, France
Site Status
CHU Hôtel-Dieu Service d'Odontologie
Clermont-Ferrand, , France
Site Status
Hospices Civils de Lyon Service de Consultations et Traitements Dentaires
Lyon, , France
Site Status
Centre Hospitalier Lyon Sud Service de Stomatologie et Chirurgie Maxillo-Faciale
Pierre-Bénite, , France
Site Status
Countries
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France
References
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Other Identifiers
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CPP 07/033 [UBET83]
Identifier Type: -
Identifier Source: secondary_id
ET2006-032
Identifier Type: -
Identifier Source: org_study_id
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