Evaluation of the Contribution of Transoral Robotic-assisted Surgery Using Da Vinci Xi for Head and Neck Tumors

NCT ID: NCT02517125

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2025-04-30

Brief Summary

Head and Neck cancers are treated either with surgical resection followed by adjuvant radiotherapy, or with organ preservation strategies using definitive radiotherapy with or without concomitant chemotherapy. These treatments have long-time functional side effects and consequences on the quality of life. Transoral robotic surgery has been developing since 2006 by Weinstein and O'Malley in alternative to open surgery, to decrease the morbidity of the large surgical approach. The da Vinci device had the FDA approval and the CE mark in 2009 for transoral surgery of head and neck cancers, using previous generations of da Vinci. The last generation da Vinci Xi has received the FDA approval for laparoscopic surgery in april 2014 and the CE mark in june 2014 but has not been evaluated yet in transoral surgery. The objective of our study is therefore to study the feasibility of this transoral robotic surgery for head and neck cancers, using the da Vinci Xi.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with head and neck cancer

Group Type: EXPERIMENTAL

Transoral robotic-assisted surgery with Da Vinci Xi

Intervention Type: DEVICE

Interventions

Transoral robotic-assisted surgery with Da Vinci Xi

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patient >/= 18

2. WHO Status 0-2

3. ENT cancer or solid tumor histologically proven regardless histology

4. All maps of the head and neck and any stage

5. surgically resectable according to clinical examination and preoperative investigations, confirmed in multidisciplinary meeting

6. Treatment:

• First-line
• Or after induction chemotherapy
• Or local recurrence regardless of the previous treatment
• Or second location in irradiated

7. Transoral exposition of tumor, assessed preoperatively during endoscopy during the balance of extension of the lesion

8. The patient must have accepted the possibility of surgical conversion open surgery

9. The patient must have been clearly informed of the study and have formulated his non-opposition to participate

Exclusion Criteria

1. Metastasis (s) clinical or radiological remote, inaccessible (s) to a local curative treatment

2. post-treatment tumor progression and / or early recurrence < 3 months

3. Unresectable tumor by robotic transorally: bone infiltration, deep infiltration of soft tissues, unresectable lymphadenopathy

4. Contraindications to the suspension for transoral tumor Exposure: Dental fragility against-indication for cervical extension

5. Pathology against intercurrent-indicating cancer surgery

6. Pregnancy

7. Inability to submit to medical monitoring study for geographical, social or psychological.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val De Marne, France

Countries

France

Other Identifiers

2015/2235

Identifier Type: OTHER

Identifier Source: secondary_id

2015-A00173-46

Identifier Type: -

Identifier Source: org_study_id