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

Upper Digestive Tract Cancer Clinical Trial

— ATIM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00925509
• Other study ID #: ET2006-032
• Secondary ID: CPP 07/033 [UBET
• Status: Terminated
• Phase: N/A
• First received: June 2, 2009
• Last updated: June 21, 2011
• Start date: September 2007
• Est. completion date: December 2011

Study information

• Verified date: June 2011
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Upper Digestive Tract Cancer

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	CHU Hôtel-Dieu Service d'Odontologie	Clermont-ferrand
France	Centre Léon Bérard Service de Chirurgie-Stomatologie	Lyon	Cedex 08
France	Hospices Civils de Lyon Service de Consultations et Traitements Dentaires	Lyon
France	Centre Hospitalier Lyon Sud Service de Stomatologie et Chirurgie Maxillo-Faciale	Pierre Benite

Sponsors (2)

Lead Sponsor	Collaborator
Centre Leon Berard	French Academic Institution, Financial support: PHRC 2007

Country where clinical trial is conducted

France, 

References & Publications (38)

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of implants insertion, radio-surgical guidance.		8 months after inclusion	No
Secondary	Accuracy of inserting implants		16 months after inclusion	No
Secondary	Delay of mucous healing		16 months after inclusion	No
Secondary	Estimation of the prosthetic function		16 months after inclusion	No
Secondary	Osteonecrosis rate after radiation with traumatic etiology due to implantation		16 months after inclusion	No
Secondary	Implant rate		16 months after inclusion	No
Secondary	Post surgical therapeutic success after 1 year		after 1 year	No