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
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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
Primary
- Evaluate the potential benefits of using the transoral robotic surgical approach against the conventional open and transoral approaches in patients with benign or malignant disease involving the larynx and pharynx.
Secondary
- Determine the proportion of laryngeal and pharyngeal surgical procedures where the surgical exposure is adequate to allow the successful completion of the surgical resection using the transoral robotic surgical approach.
OUTLINE: Patients are assigned to transoral robotic surgery or standard therapy consisting of conventional transoral endoscopic or open approach according to their preference.
Patients undergo planned surgical procedures (either diagnostic or therapeutic) appropriate for their disease in the larynx or pharynx via the transoral robotic surgical approach or the conventional transoral endoscopic or open approach.
Patients complete the Functional Assessment of Cancer Therapy Head and Neck Scale, the Performance Status Scale for Head and Neck Cancer Patients, and the University of Washington Quality of Life Scale at baseline and at 3 and 6 months. Patients also undergo voice analysis by acoustic analyses, and speech and swallow pathology evaluation by videostroboscopy and modified barium swallow.
After completion of study procedure, patients are followed at 3 and 6 months.
PROJECTED ACCRUAL: A total of 80 patients will be accrued to the control group (standard conventional surgery) and 30 patients will be accrued to the robotic surgery group.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
Michigan
-
Detroit, Michigan, Förenta staterna, 48201-1379
- Barbara Ann Karmanos Cancer Institute
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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 Characteristics
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: daVinci® Robotic Surgical System
Participants will undergo a planned surgical procedures via the robotic approach.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Operative time that directly affects operative cost
Tidsram: post operative
|
post operative
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Blodförlust
Tidsram: Under operation
|
Under operation
|
|
Intra-operative and post-operative complications
Tidsram: during the operation and post operative
|
during the operation and post operative
|
|
Need for reconstruction
Tidsram: post operative
|
post operative
|
|
Margins status
Tidsram: post operative
|
post operative
|
|
Length of hospital stay
Tidsram: during time as inpatient
|
during time as inpatient
|
|
Tracheostomy and PEG dependence
Tidsram: post operative
|
post operative
|
|
Days to oral intake
Tidsram: post operative
|
post operative
|
|
Time to locoregional recurrence
Tidsram: post operative
|
post operative
|
|
Speech intelligibility
Tidsram: post operative
|
post operative
|
|
Quality of life
Tidsram: 3 months and 6 month following completion of surgery
|
3 months and 6 month following completion of surgery
|
|
Postoperative pain
Tidsram: post operative
|
post operative
|
|
Proportion of robotic surgical cases where adequate surgical exposure allowed for successful operation completion
Tidsram: post operative
|
post operative
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Ho-Sheng Lin, MD, Barbara Ann Karmanos Cancer Institute
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
- stadium III skivepitelcancer i orofarynx
- stadium III lymfepitelom i orofarynx
- stadium III skivepitelcancer i nasofarynx
- stadium III lymfepitelom i nasofarynx
- stadium III skivepitelcancer i hypofarynx
- stadium III skivepitelcancer i struphuvudet
- stadium III verrucous karcinom i struphuvudet
- precanceröst tillstånd
- stadium I skivepitelcancer i hypofarynx
- stadium I skivepitelcancer i struphuvudet
- stadium I skivepitelcancer i nasofarynx
- stadium I skivepitelcancer i orofarynx
- stadium II skivepitelcancer i hypofarynx
- stadium II skivepitelcancer i struphuvudet
- stadium II skivepitelcancer i nasofarynx
- stadium II skivepitelcancer i orofarynx
- perioperativa/postoperativa komplikationer
- stadium I verrucous karcinom i struphuvudet
- stadium II verruköst karcinom i struphuvudet
- stadium I lymfepitelom i nasofarynx
- stadium II lymfepitelom i nasofarynx
- stadium I lymfepitelom i orofarynx
- stadium II lymfepitelom i orofarynx
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CDR0000642940
- P30CA022453 (U.S.S. NIH-anslag/kontrakt)
- WSU-2008-022
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