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Prospective Study Assessing Thyroidectomy Using Robot (EVATAR)

Primary Purpose

Patients With Thyroid Cancer

Status

Unknown status

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Da Vinci Xi

About this trial

This is an interventional treatment trial for Patients With Thyroid Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Benign thyroid nodule or follicular or suspicious cytological (Bethesda classifications 2, 3, 4, or 5) requiring thyroid lobectomy or total thyroidectomy therapeutic or diagnostic
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
Patient with no cons-indication to thyroid surgery or without dissection
Patient general condition of WHO grade 0-1
Patient age > 18 years and able to comply with the protocol visits
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)
Patient Information or his legal representative and signed consent enlightened
Patient affiliated to a system of social security or beneficiary of such a scheme

Exclusion Criteria:

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

Sites / Locations

Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Da Vinci Xi

Arm Description

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02839655

First Posted

July 12, 2016

Last Updated

June 13, 2018

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

1. Study Identification

Unique Protocol Identification Number

NCT02839655

Brief Title

Prospective Study Assessing Thyroidectomy Using Robot

Acronym

EVATAR

Official Title

Prospective Study Assessing Thyroidectomy Using Robot

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Unknown status

Study Start Date

June 30, 2016 (Actual)

Primary Completion Date

May 15, 2018 (Actual)

Study Completion Date

August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patients With Thyroid Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Da Vinci Xi

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Da Vinci Xi

Primary Outcome Measure Information:

Title

Efficacy for benign tumor

Description

Time Frame

Assessed 3 months after surgery

Title

Efficacy for malignant tumor

Description

Time Frame

Assessed 12 months after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Benign thyroid nodule or follicular or suspicious cytological (Bethesda classifications 2, 3, 4, or 5) requiring thyroid lobectomy or total thyroidectomy therapeutic or diagnostic 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 Patient with no cons-indication to thyroid surgery or without dissection Patient general condition of WHO grade 0-1 Patient age > 18 years and able to comply with the protocol visits 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) Patient Information or his legal representative and signed consent enlightened Patient affiliated to a system of social security or beneficiary of such a scheme Exclusion Criteria: A history of cervical surgery or external beam radiation therapy Anomaly craniocervical hinge or symptomatic cervical spondylosis Congenital or acquired shoulder or ipsilateral upper limb surgery (for axillary ) paralysis preoperatively ( a laryngoscopic examination will be performed systematically preoperatively ) tumors with obvious extra- thyroid extension or suspected during preoperative ( cT3T4 ) metastatic cervical lymphadenopathy > 10 mm during the preoperative Pregnant women or during lactation patient already included in another clinical trial with a molecule experimental

Facility Information:

Facility Name

Gustave Roussy

City

Villejuif

State/Province

Val De Marne

ZIP/Postal Code

94805

Country

France

12. IPD Sharing Statement

Plan to Share IPD

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Prospective Study Assessing Thyroidectomy Using Robot

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