Clinical trial · Interventional
Transoral Robotic Surgery or Standard Surgery in Treating Patients With Benign or Malignant Tumors of the Larynx and Pharynx
A Pilot Study Assessing the Use of DA VINCI® Robotic Surgical System in Laryngeal and Pharyngeal Surgeries
- 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)
RATIONALE: Transoral robotic surgery may make it easier to find and remove benign or malignant tumors of the larynx and pharynx and cause less damage to normal tissue. It is not yet known whether transoral robotic surgery is more effective than standard surgery in diagnosing and treating larynx and pharynx tumors. PURPOSE: This phase I trial is studying how well transoral robotic surgery works compared with standard surgery in treating patients with benign or malignant tumors of the larynx or pharynx.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Perioperative/Postoperative Complications | — | UNRESOLVED | — |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| diagnostic endoscopic surgery | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
| therapeutic endoscopic surgery | Procedure | — | UNRESOLVED |
| transoral robotic surgery | Procedure | — | UNRESOLVED |
| video-assisted surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- daVinci® Robotic Surgical System
- description
- Participants will undergo a planned surgical procedures via the robotic approach.
- interventionNames
- Procedure: assessment of therapy complications
- Procedure: diagnostic endoscopic surgery
- Procedure: quality-of-life assessment
- Procedure: therapeutic conventional surgery
- Procedure: therapeutic endoscopic surgery
- Procedure: transoral robotic surgery
- Procedure: video-assisted surgery
Primary outcomes (1)
- measure
- Operative time that directly affects operative cost
- timeFrame
- post operative
Secondary outcomes (12)
- measure
- Blood loss
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Benign or malignant disease of the larynx or pharynx that requires surgical intervention for either diagnostic or therapeutic purposes
* Malignant disease must meet the following criteria:
* Histologically confirmed diagnosis of 1 of the following:
* Glottic cancer (T1, T2, and T3)
* Supraglottic cancer (T1, T2, and T3)
* Hypopharyngeal cancer (T1 and T2)
* Oropharyngeal cancer (T1, T2, and T3)
* Nasopharyngeal cancer (T1 and T2)
* Resectable involved lymph nodes
* No invasion of osseous and/or osseocartilaginous structures including the following:
* Mandibular bone
* Thyroid cartilage
* Hyoid bone
* Cricoid bone
* Vertebral body
* No pharyngeal wall or tongue-based involvement requiring resection of \> 50% of the posterior pharyngeal wall or tongue base
* No radiological confirmation of carotid artery involvement
* No fixation of tumor to the prevertebral fascia
* No bilateral arytenoid involvement
* No surgical defect requiring open approach for reconstruction
* No evidence of distant metastasis
PATIENT CHARACTERISTICS:
* Not pregnant
* No unexplained fever and/or untreated active infection
* No medical conditions contraindicating general anesthesia
* No inadequate jaw opening due to prior head and neck surgery, trauma, or radiotherapy
PRIOR CONCURRENT THERAPY:
* See Disease CharacteristicsReferences
Publications (0)
Data not yet available