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

NCT00925509 | Terminated

• 2 other identifiers: ET2006-032CPP 07/033 [UBET83]
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (1)

• Accuracy of implants insertion, radio-surgical guidance.

  8 months after inclusion

Secondary Outcomes (6)

• Accuracy of inserting implants

  16 months after inclusion

• Delay of mucous healing

  16 months after inclusion

• Estimation of the prosthetic function

  16 months after inclusion

• Osteonecrosis rate after radiation with traumatic etiology due to implantation

  16 months after inclusion

• Implant rate

  16 months after inclusion

Interventions

Therapeutic assessment -Radio-surgical guidance. PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Leon Berard: lead
• French Academic Institution, Financial support: PHRC 2007: collaborator

Study Sites (4)

Centre Léon Bérard Service de Chirurgie-Stomatologie

Lyon, Cedex 08, 69373, France

Location

CHU Hôtel-Dieu Service d'Odontologie

Clermont-Ferrand, 63 000, France

Location

Hospices Civils de Lyon Service de Consultations et Traitements Dentaires

Lyon, 69007, France

Location

Centre Hospitalier Lyon Sud Service de Stomatologie et Chirurgie Maxillo-Faciale

Pierre-Bénite, 69495, France

Location

Related Publications (38)

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Study Officials

• Anne-Gaëlle BODARD, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 22, 2009
• Study Start: September 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 22, 2011

Record last verified: 2011-06

Locations

FR (4)