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

NCT01257633 | Completed

• 2 other identifiers: AOI/2010/BL-012010-A01190-39
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Laryngeal Neoplasms

Keywords

da Vinci surgical robot; laryngeal cancer

Outcome Measures

Primary Outcomes (1)

• The presence/absence of cancerous tissue in the surgical margins of the resectioned tumors

  1 day

Secondary Outcomes (7)

• Time to prepare the surgical setting (min)

  1 day

• Time necessary to dock the robot (min)

  1 day

• Total surgical time (console time) (min)

  1 day

• Intervention time taking into account cervical ganglions (min)

  1 day

• Was a tracheotomy necessary? yes/no

  1 day

Study Arms (1)

The study population

Laryngeal cancer patients requiring surgical tumor resection.

Procedure: Transoral robot-assisted tumor resection using the da Vinci robot

Interventions

Transoral robot-assisted tumor resection using the da Vinci robot PROCEDURE

Transoral robot-assisted tumor resection using the da Vinci robot

The study population

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (3)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

Location

CHU de Montpellier - Hôpital Gui de Chauliac

Montpellier, 34295, France

Location

CHRU de Toulouse - Hôpital de Rangueil

Toulouse, 31059, France

Location

Related Publications (1)

• Lallemant B, Moriniere S, Ceruse P, Lebalch M, Aubry K, Hans S, Dolivet G, Malard O, Bonduelle Q, Vergez S. Transoral robotic surgery for squamous cell carcinomas of the posterior pharyngeal wall. Eur Arch Otorhinolaryngol. 2017 Dec;274(12):4211-4216. doi: 10.1007/s00405-017-4771-9. Epub 2017 Oct 14.

  PMID: 29032418 RESULT

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Study Officials

• Benjamin Lallemant, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 10, 2010
• Study Start: April 1, 2011
• Primary Completion: September 30, 2014
• Study Completion: September 30, 2014
• Last Updated: November 17, 2025

Record last verified: 2015-03

Locations

FR (3)