Da Vinci Transoral Robotic-assisted Surgery of Pituitary Gland
Phase: NA
Conditions: Pituitary Neoplasms
Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

 
 
 
DA VINCI TRANSORAL ROBOTIC-ASSISTED SURGERY  
OF PITUITARY GLAND 
 
ACRONYM: ROBOPHYSE 
 
BIOMEDICAL RESEARCH RELATING TO A MEDICAL DEVICE 
 
NCT 02743442  
DCT-2015-043  
IDRCB: 2015-A01597-42 
February 01, 2019 
 
 
 
 
 
Introduction 
In recent years, pituitary surgery has been enriched with endoscopic techniques. However, the 
latter still have some problems: endonasal complications, tightness of the focus, limited 
instrument handling, 2D vision. Many surgical specialties have adopted the da Vinci system 
(urology, oto rhino laryngology, gynecology, etc.) to improve their interventions with the 
following advantages: 3D vision, instrument maneuverability, abolition of physiological tremor. 
 
Hypotheses 
Following our published cadaveric work (Chauvet et al., Neurosurgical Review 2014), we propose a 
new minimally invasive technique of pituitary surgery, transoral, assisted by the da Vinci robot. 
 
Primary Objective 
To confirm the feasibility of a new minimally invasive technique of pituitary surgery, transoral, 
assisted by the da Vinci robot 
 
Secondary Objectives 
- To improve post-operative outcomes and comorbidities related to this surgery 
- To improve average lengths of stay 
 
Main Evaluation Criterion 
Feasibility of tumor (pituitary adenomas) resection 
 
Secondary Evaluation Criteria  
1) Accessibility of the sella turcica 
2) Occurrence of adverse events attributable to surgery 
3) Duration of postoperative hospital stay 
 

 
Methodology 
This is a biomedical research on a group of patients with pituitary adenoma. 
This work seeks to test a new robot surgical technique - already used in other surgical specialties - in 
neurosurgery for pituitary tumors. 
The operative indications will be set according to the usual criteria and confirmed during collegial 
meetings in the Department of Neurosurgery of the Ophthalmological Foundation A. de Rothschild 
(Paris, France). 
The surgical procedure will be performed in the operating room of the Otorhinolaryngology and 
Head and Neck Surgery Department of the European Hospital Georges Pompidou (Public Assistance 
of Paris Hospitals, France), which already uses the da Vinci robot. An intraoperative radiography 
system will be used during the guiding procedure. At any time during surgery, a conversion for a 
conventional endoscopic pathway will be feasible to overcome any technical problems related to the 
robot (never reported during cadaveric work). 
The postoperative follow-up will be done in the Neurosurgery Department of the Ophthalmological 
Foundation A. de Rothschild (Paris) according to the standard protocols. 
 
Inclusion Criteria 
1) Pituitary adenoma with an indication for surgery: visual compression and chiasmatic 
syndrome, HTIC, hormonal syndrome (hypopituitarism and hypersecretion), failure of drug 
treatments for prolactinoma 
2) Absence of pituitary apoplexy requiring emergency surgery; 
3) Spontaneous mouth opening greater than 35 mm 
4)  Patient affiliated to a social security scheme (or benefiting from the “Couverture Médicale 
Universelle”); 
5) Patient having signed a prior, free and informed consent. 
 
Non-inclusion Criteria 
1) Insufficient mouth opening 
2) Intercurrent pathology (such as infection) of the oropharyngeal sphere and cavum 
3) Complicated forms of pituitary adenoma with invasive pituitary adenoma type 
4) Haemostatic disorders (thrombocytopenia <75,000 platelets / mm3, TP <60%, INR> 1.5, 
ongoing antiplatelet or anticoagulant therapy) 
5) Phlebitis or active pulmonary embolism 
6) Patient under judicial protection 
7) Pregnant or lactating woman 
 
Statistical Analysis Plan 
The statistical analyzes will be exclusively descriptive. 
Continuous variables will be described using the usual position and dispersion statistics, namely 
mean, median, variance, minimum, maximum and quartiles. The modalities of the qualitative 
variables will be described using numbers and proportions. 
 
Number of subjects needed: 8 
Total duration of study: 31 months 
Inclusion period: 24 months 
Duration of participation for a patient: approximately 7 months   
Number of participating centers: 1 
Average number of inclusions per month per center: 1