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A Pilot Study Assessing the Use of DA VINCIĀ® Robotic Surgical System in Laryngeal and Pharyngeal Surgeries


Phase 1
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Perioperative/Postoperative Complications, Precancerous Condition

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Trial Information

A Pilot Study Assessing the Use of DA VINCIĀ® Robotic Surgical System in Laryngeal and Pharyngeal Surgeries


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Operative time that directly affects operative cost

Safety Issue:

No

Principal Investigator

Ho-Sheng Lin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000642940

NCT ID:

NCT00918762

Start Date:

May 2009

Completion Date:

October 2010

Related Keywords:

  • Head and Neck Cancer
  • Perioperative/Postoperative Complications
  • Precancerous Condition
  • perioperative/postoperative complications
  • precancerous condition
  • stage I squamous cell carcinoma of the hypopharynx
  • stage II squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage I squamous cell carcinoma of the larynx
  • stage I verrucous carcinoma of the larynx
  • stage II squamous cell carcinoma of the larynx
  • stage II verrucous carcinoma of the larynx
  • stage III squamous cell carcinoma of the larynx
  • stage III verrucous carcinoma of the larynx
  • stage I lymphoepithelioma of the nasopharynx
  • stage I squamous cell carcinoma of the nasopharynx
  • stage II lymphoepithelioma of the nasopharynx
  • stage II squamous cell carcinoma of the nasopharynx
  • stage III lymphoepithelioma of the nasopharynx
  • stage III squamous cell carcinoma of the nasopharynx
  • stage I lymphoepithelioma of the oropharynx
  • stage I squamous cell carcinoma of the oropharynx
  • stage II lymphoepithelioma of the oropharynx
  • stage II squamous cell carcinoma of the oropharynx
  • stage III lymphoepithelioma of the oropharynx
  • stage III squamous cell carcinoma of the oropharynx
  • Head and Neck Neoplasms
  • Postoperative Complications
  • Precancerous Conditions

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201