Clinical trial · Observational
Surgical Treatment of Early Stage Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance
Observational Study on Surgical Treatment of Early Stage (T1-T2) Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance
NCT01257633CI-TRIAL-00097297completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Laryngeal Neoplasms | Laryngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transoral robot-assisted tumor resection using the da Vinci robot | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- The study population
- description
- Laryngeal cancer patients requiring surgical tumor resection.
- interventionNames
- Procedure: Transoral robot-assisted tumor resection using the da Vinci robot
Primary outcomes (1)
- measure
- The presence/absence of cancerous tissue in the surgical margins of the resectioned tumors
- timeFrame
- 1 day
Secondary outcomes (7)
- measure
- Time to prepare the surgical setting (min)
- timeFrame
- 1 day
- measure
- Time necessary to dock the robot (min)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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: \-
References
Publications (1)
- RESULTLallemant 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