Da Vinci Transoral Robotic-assisted Surgery of Pituitary Gland

NCT02743442 | Terminated Results

• 1 other identifier: DCT-2015-043
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pituitary Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Duration of Surgery

  3 hours

• Number of Severe Adverse Events

  6 months

• Duration of Hospitalization

  1 month

Study Arms (1)

Transoral surgery

EXPERIMENTAL

Device: da Vinci® Si™

Interventions

da Vinci® Si™ DEVICE

Transoral surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr Amélie Yavchitz (deputy head of the clinical research unit)
• Organization: Fondation Ophtalmologique A. de Rothschild

ayavchitz@for.paris

+33148036454

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 19, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: September 1, 2018
• Last Updated: March 29, 2021
• Results First Posted: March 29, 2021

Record last verified: 2021-03

Locations

FR (1)