Da Vinci Transoral Robotic-assisted Surgery of Pituitary Gland (ROBOPHYSE)

Fondation Ophtalmologique Adolphe de Rothschild

Status: Terminated

Conditions: Pituitary Neoplasms

Treatments: Device: da Vinci® Si™

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02743442

DCT-2015-043

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Transoral surgery

Experimental group

Treatment:

Device: da Vinci® Si™