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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01257633
First received: December 9, 2010
Last updated: March 3, 2014
Last verified: March 2014
  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:


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 ]

Enrollment: 54
Study Start Date: April 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, Gard, France, 30029
CHU de Montpellier - Hôpital Gui de Chauliac
Montpellier, France, 34295
CHRU de Toulouse - Hôpital de Rangueil
Toulouse Cedex 9, France, 31059
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 3, 2014
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:
Laryngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on October 01, 2014