Da Vinci Transoral Robotic-assisted Surgery of Pituitary Gland

Pituitary Neoplasms Clinical Trial

— ROBOPHYSE  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02743442
• Other study ID #: DCT-2015-043
• Status: Terminated
• Phase: N/A
• Start date: March 2016
• Est. completion date: September 2018

Study information

• Verified date: March 2021
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Over the past 30 years, endoscopic transnasal techniques have gained a major interest, and anatomic limits have been widened in order to extend neurosurgical applications. For many years, robotic-assisted surgery using the da Vinci system (Intuitive Surgical Inc, Sunnyvale, California, USA) has been greatly developed, especially in urology and gynecology. Robotic-assisted surgery has been performed for pharyngeal and laryngeal cancers in a minimally invasive perspective. A robot-assisted preliminary series demonstrated the ability to approach the sella via oral approach without traumatic injury of nasal or oral cavity. Transoral approach avoids the complications of the endonasal resection: synechia, rhinitis sicca anterior, primary and secondary atrophican rhinitis, and empty nose syndrome. The investigators recently published a cadaveric study of transoral robotic-assisted skull base surgery to approach the sella turcica (Neurosurgical Rev. 2014; 37:609-17). In this study, the investigators will propose a new minimally invasive technique of pituitary surgery by transoral approach assisted by the da Vinci robot in patients with pituitary adenoma.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: September 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pituitary adenoma with a surgical indication : visual compression and chiasmal syndrome, intracranial hypertension , hormonal syndrome (hypopituitarism and hypersecretion ) , failure of medicamentous treatments for prolactinoma
• No pituitary apoplexy (requiring emergency surgery)
• Spontaneous oral opening greater than 35 mm

Exclusion Criteria:

• Insufficient buccal opening
• Intercurrent pathology of oropharyngeal and nasopharyngeal
• Complicated forms of adenoma pituitary adenoma (invasive adenoma)
• Hemostasis disorder
• Phlebitis or active pulmonary embolism

Related Conditions & MeSH terms

• Pituitary Diseases
• Pituitary Neoplasms

Intervention

Device:
• da Vinci® Si™

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Operated Via da Vinci Robot	Number of patients in which the entire sella turcica (including its anterior face) is seen during surgery and reached by the robotic arms	1 day
Secondary	Duration of Surgery	Total duration of surgery: installation, mucosal time, sphenoidal time, resection and closure	3 hours
Secondary	Number of Severe Adverse Events	An adverse event occurring after the procedure is serious if it causes death, endangers the life of the person who is suitable for research, requires or prolongs hospitalization, causes a significant handicap, results in a congenital malformation, or is considered medically significant.	6 months
Secondary	Duration of Hospitalization	Duration of hospitalization after surgery	1 month