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

November 14, 2025 updated by: Centre Hospitalier Universitaire de Nīmes

Observational Study on Surgical Treatment of Early Stage (T1-T2) Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • CHU de Montpellier - Hôpital Gui de Chauliac
      • Toulouse, France, 31059
        • CHRU de Toulouse - Hôpital de Rangueil
    • Gard
      • Nîmes, Gard, France, 30029
        • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

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.

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The presence/absence of cancerous tissue in the surgical margins of the resectioned tumors
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to prepare the surgical setting (min)
Time Frame: 1 day
1 day
Time necessary to dock the robot (min)
Time Frame: 1 day
1 day
Total surgical time (console time) (min)
Time Frame: 1 day
1 day
Intervention time taking into account cervical ganglions (min)
Time Frame: 1 day
1 day
Was a tracheotomy necessary? yes/no
Time Frame: 1 day
1 day
Presence / absence of bleeding complications
Time Frame: 1 day
1 day
Was a conversion to an open procedure necessary? yes/no
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Benjamin Lallemant, MD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

September 30, 2014

Study Completion (Actual)

September 30, 2014

Study Registration Dates

First Submitted

December 9, 2010

First Submitted That Met QC Criteria

December 9, 2010

First Posted (Estimated)

December 10, 2010

Study Record Updates

Last Update Posted (Estimated)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOI/2010/BL-01
  • 2010-A01190-39 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Laryngeal Neoplasms

Clinical Trials on Transoral robot-assisted tumor resection using the da Vinci robot

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe