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


N/A
18 Years
N/A
Not Enrolling
Both
Upper Digestive Tract Cancer

Thank you

Trial Information

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


- 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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Accuracy of implants insertion, radio-surgical guidance.

Outcome Time Frame:

8 months after inclusion

Safety Issue:

No

Principal Investigator

Anne-Gaëlle BODARD, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Leon Berard

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

ET2006-032

NCT ID:

NCT00925509

Start Date:

September 2007

Completion Date:

December 2011

Related Keywords:

  • Upper Digestive Tract Cancer
  • 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

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