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

NCT ID: NCT01257633

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Laryngeal Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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The study population

Laryngeal cancer patients requiring surgical tumor resection.

Transoral robot-assisted tumor resection using the da Vinci robot

Intervention Type PROCEDURE

Transoral robot-assisted tumor resection using the da Vinci robot

Interventions

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Transoral robot-assisted tumor resection using the da Vinci robot

Transoral robot-assisted tumor resection using the da Vinci robot

Intervention Type PROCEDURE

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin Lallemant, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, France

Site Status

CHU de Montpellier - Hôpital Gui de Chauliac

Montpellier, , France

Site Status

CHRU de Toulouse - Hôpital de Rangueil

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 29032418 (View on PubMed)

Other Identifiers

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2010-A01190-39

Identifier Type: OTHER

Identifier Source: secondary_id

AOI/2010/BL-01

Identifier Type: -

Identifier Source: org_study_id

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