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Surgical Treatment of Early Stage Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance

This study is currently recruiting participants.
Verified March 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01257633
First received: December 9, 2010
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
  Purpose

The main objective of this study is to determine the rate of healthy surgical margins after tumor resection in transoral robot-assisted surgery for glottic and/or supraglottic early stage (T1-T2) laryngeal cancer.


Condition Intervention
Laryngeal Neoplasms
 Procedure: Transoral robot-assisted tumor resection using the da Vinci robot

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study on Surgical Treatment of Early Stage (T1-T2) Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • The presence/absence of cancerous tissue in the surgical margins of the resectioned tumors [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to prepare the surgical setting (min) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Time necessary to dock the robot (min) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Total surgical time (console time) (min) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Intervention time taking into account cervical ganglions (min) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Was a tracheotomy necessary? yes/no [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Presence / absence of bleeding complications [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
  • Was a conversion to an open procedure necessary? yes/no [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: April 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
The study population
Laryngeal cancer patients requiring surgical tumor resection.
 Procedure: Transoral robot-assisted tumor resection using the da Vinci robot
Transoral robot-assisted tumor resection using the da Vinci robot

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This study is aimed at all patients with early stage (T1 or T2) glottic and / or supraglottic squamous cell carcinoma of the larynx, whatever their status and cervical lymph nodes without distant metastases (M0) and for whom endoscopic surgical treatment with robotic assistance is indicated following a multidisciplinary meeting.

Criteria

Inclusion Criteria:

  • The subject has signed consent
  • The subject must be a member or beneficiary of a health insurance plan
  • The patient is available for 12 months of follow-up
  • The subject has a cancer of the larynx:
  • classified T1 or T2 in the TNM
  • glottic localization and / or supraglottic regardless of node status
  • with or without a history of head and neck cancer
  • The subject does not have distant metastasis (M0)
  • A decision for endoscopic robot-assisted surgery is retained in multidisciplinary meeting

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257633

Contacts
Contact: Benjamin M Lallemant, MD +33.4.66.68.32.73 benjamin.lallemant@chu-nimes.fr
Contact: Carey M Suehs 3466686788 carey.suehs@chu-nimes.fr

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes, Gard, France, 30029
Principal Investigator: Benjamin Lallemant, MD            
Sub-Investigator: Guillaume Chambon, MD            
Sub-Investigator: Jean-Gabriel Lallemant, MD PhD            
CHU de Montpellier - Hôpital Gui de Chauliac Recruiting
Montpellier, France, 34295
Sub-Investigator: Renaud Garrell, MD            
Sub-Investigator: César Cartier, MD            
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Benjamin Lallemant, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01257633     History of Changes
Other Study ID Numbers: AOI/2010/BL-01
Study First Received: December 9, 2010
Last Updated: March 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
da Vinci surgical robot
laryngeal cancer

Additional relevant MeSH terms:
Neoplasms
Laryngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
 Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on June 17, 2013