Assessing the da Vinci® Robotic Surgical System for Surgery of the Upper Aerodigestive Tract

Head and Neck Cancers Clinical Trial

Official title:

A Pilot Study Assessing Transoral Robotic Surgery (TORS) For Oral And Laryngopharyngeal Benign And Malignant Lesions Using The da Vinci® Robotic Surgical System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00721539
• Other study ID #: ENT0026
• Secondary ID: SU-07152008-1258
• Status: Terminated
• Phase: N/A
• First received: July 22, 2008
• Last updated: November 2, 2016
• Start date: September 2010
• Est. completion date: September 2012

Study information

• Verified date: November 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To assess the use of the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) in transoral surgeries in patients with benign and malignant lesions of the oral cavity and laryngopharynx.

Description:

In the past two decades the interest in minimally invasive techniques for transoral treatment of head and neck benign and malignant lesions has been growing due to the decreased morbidity of transoral approaches, and some surgeons have been moving away from traditional open resections. Transoral resection of neoplasms of the upper aerodigestive, by its minimally invasive nature, may afford a shorter hospitalization and recovery time for patients when compared to those patients who undergo traditional "open" surgery. In surgery of the oropharynx, hypopharynx, and larynx, transoral endoscopic surgery can provide similar outcomes in terms of local control of disease when compared to open procedures, while improving time to restoration of oral intake and shortening time to tracheostomy decannulation. Therefore, in select patients, a transoral surgical approach may afford clear advantages over traditional open approaches. Current techniques, however, are limited by the inability to attain direct line of site exposure of the lesion. Use of robot-assisted technology as a means to overcome surgical limitations, to provide surgeons with improved dexterity and precision, and to couple advanced imaging techniques with three-dimensional depth perception, may allow for the completion of transoral surgical approaches in patients for whom conventional technology has been suboptimal.

The da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) is FDA-approved for use in a variety of laparoscopic, thoracoscopic, cardiac, and urologic surgical procedures. This protocol will assess the use of the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) in transoral surgeries in patients with benign and malignant lesions of the oral cavity and laryngopharynx. Traditional endoscopic removal of tumors of the oropharynx and laryngopharynx is usually preferred to traditional open resection because of the decrease in morbidity and improved functional outcomes experienced by patients. The limiting step in these procedures has been exposure of, visualization of, and access to candidate tumors. The da Vinci surgical system offers the possibility of significant improvements in exposure, visualization and access to these candidate tumors with no added risk to patients. Overall this may significantly increase the number of patients who are candidates for endoscopic surgery. Alternative procedures will include traditional open surgical removal of tumors as well as traditional endoscopic removal of tumors using the microscope and CO2 laser. Open surgical approaches are reserved for patients who have large tumors unsuitable for endoscopic removal or in whom endoscopic visualization of the tumor is inadequate or impossible. The da Vinci surgical system would offer improved visualization of tumors that might otherwise be inaccessible to a traditional endoscopic approach.

Candidate patients will present with a neoplasm of the oropharynx, hypopharynx or larynx. Those patients assessed preoperatively to be candidates for transoral surgery (eg, Mallampati class I or II, normal range of neck motion, no trismus) will undergo surgery via a transoral approach to resect the tumor. This will require general anesthesia and may require postoperative hospitalization. If the tumor can be accessed, resection will proceed using the da Vinci robot. In whom the tumor cannot be accessed, resection will proceed via the conventional open approach. Pre and postoperative care will not be affected by this protocol, as it deals strictly with the manner in which the tumor is removed. Postoperative care and visits are standardized as to the nature of the tumor (eg, malignant tumors usually require follow-up visits every four to six weeks to monitor for tumor recurrence). Complications, blood loss, operative time, length of hospitalization, time to resumption of oral intake, time to decannulation, and overall local control rates will be assessed in the postoperative period.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient or volunteer is 18 years of age or older

• Patients must have indication for diagnosis and/or therapy of diseases of the oropharynx, hypopharynx, and/or larynx.

Exclusion Criteria:

• unexplained fever and/or untreated

• active infection

• pregnancy

• anatomic parameters which preclude transoral surgery, such as:

1. trismus

2. limited range of neck motion

3. poor dentition

4. redundant hypopharyngeal or supraglottic tissue which would prevent adequate visualization of the tumor

• participation in a research protocol which precludes participation in other protocols

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Head and Neck Cancers
• Head and Neck Neoplasms
• Hypopharyngeal Neoplasms
• Laryngeal Neoplasms
• Neoplasms

Intervention

Device:
• da Vinci Surgical Robot Platform
daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.

Procedure:
• Transoral Robotic Surgery
Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Complication Rate (Intraoperative and Postoperative)	Complications encountered intraoperatively or up to six weeks postoperatively. This would include injury to patient, hemorrhage, lacerations, and readmission following surgery.	Six weeks	No
Secondary	Feasibility Defined as Ability to Perform the Planned Diagnostic or Therapeutic Procedure		Six weeks	No
Secondary	Average Blood Loss	Blood lost during procedure	Duration of procedure up to two hours	No
Secondary	Average Operative Time	Average operative time in minutes	Up to four hours (240 minutes)	No