Prospective Study Assessing Thyroidectomy Using Robot (EVATAR)

The robot-assisted surgery for benign and malignant thyroid tumors was widely developed in Asia and begins to spread in Western countries. The main advantage of the technique is to avoid a scar in the neck by placing it either in the axilla or at the hairline behind the ear to improve esthetic consequences and body image. It is not surgery minimally invasive but rather a way of remote access surgery.

Data from the literature including cohort studies and meta-analyzes attest the security of the procedure in comparison with classic thyroid surgery (which remains the "gold standard"). However there is few data on the effectiveness of the technique in terms of the completeness of the surgery, according to the routine standard criteria used in endocrinology and endocrine cancer, and no French medico-economic study has been performed.

Study Overview

• Status: Unknown
• Conditions: Patients With Thyroid Cancer
• Intervention / Treatment: Device: Da Vinci Xi

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Val De Marne
    • Villejuif, Val De Marne, France, 94805
      • Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Benign thyroid nodule or follicular or suspicious cytological (Bethesda classifications 2, 3, 4, or 5) requiring thyroid lobectomy or total thyroidectomy therapeutic or diagnostic
2. Differentiated thyroid cancers - CN0 (no suspicious lymph node in the central or lateral compartments on preoperative ultrasound - CN1A / b with lymph node metastases <or = 10 mm in areas VI, III and / or IV, detected on preoperative ultrasound - For which the indication of a lobectomy or total thyroidectomy, with or without dissection of the central compartment and / or lateral neck was put in multidisciplinary meeting
3. Patient with no cons-indication to thyroid surgery or without dissection
4. Patient general condition of WHO grade 0-1
5. Patient age > 18 years and able to comply with the protocol visits
6. Patient agreeing to undergo robot-assisted surgery, the incision being at patient choice, depending on the wishes concerning the location of the scar (Axillary or behind the ear channel)
7. Patient Information or his legal representative and signed consent enlightened
8. Patient affiliated to a system of social security or beneficiary of such a scheme

Exclusion Criteria:

1. A history of cervical surgery or external beam radiation therapy
2. Anomaly craniocervical hinge or symptomatic cervical spondylosis
3. Congenital or acquired shoulder or ipsilateral upper limb surgery (for axillary )
4. paralysis preoperatively ( a laryngoscopic examination will be performed systematically preoperatively )
5. tumors with obvious extra- thyroid extension or suspected during preoperative ( cT3T4 )
6. metastatic cervical lymphadenopathy > 10 mm during the preoperative
7. Pregnant women or during lactation
8. patient already included in another clinical trial with a molecule experimental

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Da Vinci Xi	Device: Da Vinci Xi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy for benign tumor	If total thyroidectomy : rate of patients with thyroglobulin (Tg) under non- suppressive treatment with L-thyroxine ( LT4 ) <2 ng / ml to 3 months with a target value TSH between 0.5 and 2 ng / mL If lobectomy : size of the remaining thyroid ipsilateral to the surgery evaluated sonographically <11 mm ( larger diameter ) to 3 months	Assessed 3 months after surgery
Efficacy for malignant tumor	Rate of patients in complete remission at 12 months, remission defined as no biological or radiological anomaly: Tg / LT4 < 2 ng / ml in the absence of treatment with 131I ( in the absence of anti Tg antibodies) or Tg / LT4 <0.2 ng / mL in patients treated with 131I (absent anti Tg antibody ); Normal cervical ultrasound; Normal SPECT -CT if treatment with 131I; If realized : CT and / or normal 18 FDG - PET	Assessed 12 months after surgery

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2016
• Primary Completion (Actual): May 15, 2018
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: July 12, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (Estimate): July 21, 2016

Study Record Updates

• Last Update Posted (Actual): June 15, 2018
• Last Update Submitted That Met QC Criteria: June 13, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Thyroid Diseases; Head and Neck Neoplasms; Thyroid Neoplasms
• Other Study ID Numbers: 2015-A00989-40; 2015/2273 (Other Identifier: CSET Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO