TOETVA Technique Compared With Anterior Cervical Thyroidectomy (AC) in Terms of Efficacy and Safety

Официальное название

Prospective Randomized Multicenter Trial Comparing the Efficacy and Safety of the Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) Versus Anterior Cervical Thyroidectomy (AC)

Обзор

Nearly 50,000 thyroidectomies are performed in France each year for benign and malignant pathologies. Each one affects the life of the patient and represents, for some, suffering, symbolized by the stigma of the operation. The consequences of these scars vary according to the patient, their experience and their culture. For example, cervicotomies are particularly badly accepted in Asia since they are supposed to interrupt the fertility meridian. In France, increasing attention is being paid to the global management of a person with some disease. As a disease state may be transitory, the medical team must consider the situation "after the illness" and plan a return to normality. In particular, alternative approaches to cervicotomy have been developed, in which the scar is in a less visible location, at the cost of a more extensive dissection. These techniques include the transaxillary approach, the bi-areolar biaxillary approach and the retroauricular approach. Such procedures, initially developed as an endoscopic approach, have become progressively robotically assisted, to help with the ergonomics of the procedure. Even though robotic assistance initially helped to spread use of these techniques, it has, over time, limited them, first because of higher cost, and second because of the high learning curve (50 to 75 cases). Finally, the transaxillary approach, which is the most commonly performed, has an inherent problem due to the decreased visibility of the noble structures on the contralateral side, leading to frequent subtotal resection. Since 2014, the Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) has been developed as an alternative to these robot-assisted procedures. Because this technique offers the surgeon similar access to the anatomical structures on both sides of the trachea and makes it possible to identify the noble structures to be preserved, TOETVA is currently undergoing a more widespread use in France and worldwide and more candidates for are being offered the procedure. TOETVA reduces the need for dissection to reach the thyroid gland. Moreover, this procedure does not require any special equipment, even if robotic assistance has been used in transoral thyroidectomy. Just like the electric light was not developed from the continuous improvement of candles, entirely new approaches are sometimes necessary in surgery. The Scientific Committee of the French Association of Endocrine Surgery is convinced that TOETVA, will become more widely used in France, even if this technique is a major departure from the standard approach. However, it is technically more demanding and must, therefore, be evaluated and supervised. This will require a safety study and a comparison with the current reference procedure, the anterior cervical thyroidectomy (AC). The investigators assume, based on our initial experience, that the use of endoscopic equipment and its magnification will allow good visualization of the noble elements (recurrent nerve and parathyroid glands) and that the complication rate of TOETVA will not be higher than that of the reference approach. The investigators propose to evaluate, through a prospective randomized study, an innovative endocrine surgical technique that has started to be used worldwide. Although this study is in line with the objectives of an evaluation of the pertinence of care by the health authorities, it would be the first assessment of this innovative surgical technique in thyroid surgery. To our knowledge, after an extensive bibliographic search, no prospective multicenter randomized trial comparing TOETVA to AC has yet been performed, even if many cohorts of patients have been reported to have benefited from this approach6. In this trial, any change to the quality of life will be extensively evaluated. The use of validated scores to quantify pain and quality of life will provide objective information and make it possible to determine the impact of the presence or absence of a scar.

Вмешательства

• Процедура Transoral Endoscopic Thyroidectomy by Vestibular Approach
  Transoral Endoscopic Thyroidectomy by Vestibular Approach
• Процедура Anterior Cervical thyroidectomy
  Anterior Cervical thyroidectomy

Первичные конечные точки

• To demonstrate the non-inferiority of TOETVA compared to AC in terms of early postoperative complications (during the first 24 hours) in patients with a surgical indication for lobectomy or total thyroidectomy without associated lymph node procedure. [Срок оценки: during the first 24 hours]

Вторичные конечные точки (5)

• To compare, between the two surgical approaches (TOETVA vs. AC) in patients with a surgical indication for lobectomy or total thyroidectomy without associated lymph node procedure, the rate of mid-term postoperative complications [Срок оценки: within 30 days of surgery]
• To compare, between the two surgical approaches (TOETVA vs. AC) in patients with a surgical indication for lobectomy or total thyroidectomy without associated lymph node procedure, the quality of life at 1 month after surgery [Срок оценки: at 1 month after surgery]
• To compare, between the two surgical approaches (TOETVA vs. AC) in patients with a surgical indication for lobectomy or total thyroidectomy without associated lymph node procedure, the quality of life at 6 months after surgery [Срок оценки: at 6 months after surgery]
• To compare, between the two surgical approaches (TOETVA vs. AC) in patients with a surgical indication for lobectomy or total thyroidectomy without associated lymph node procedure, the evolution of pain at 1 month after surgery [Срок оценки: at 1 month after surgery]
• To compare, between the two surgical approaches (TOETVA vs. AC) in patients with a surgical indication for lobectomy or total thyroidectomy without associated lymph node procedure, the evolution of pain at 6 months after surgery [Срок оценки: at 6 months after surgery]

Критерии участия

Критерии включения

• Patients with a surgical indication for lobectomy or thyroidectomy
• Estimated thyroid volume measured by ultrasonography of less than 60 mL
• Nodules suspected to be malignant measuring less than 4 cm
• Patient aged between 18 and 65 years old
• Patient who has benefited from an endocrinological evaluation, with a favorable opinion for TOETVA or AC Patient who understands and accepts the need for follow-up
• Patient who agrees to be included in the study and who signs the informed consent form
• Patient affiliated to a healthcare insurance plan

Критерии исключения

• Patients refusing an alternative to AC or refusing AC
• History of cervical surgery
• Associated parathyroid surgery
• Identification of malignant lymph nodes
• Presence of a severe and evolutive life threatening pathology
• Patients with unstable psychiatric disorder, under supervision or guardianship
• Patient who does not understand French/ is unable to give consent
• Patient not affiliated to a French or European healthcare insurance
• Patient who has already been included in a trial which has a conflict of interests with the present study
• Pregnant or breast-feeding patient
• Patient incarcerated

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 10 центров

• AP-HP - Hôpital Avicennes — Bobigny
• Hôpital Franco-Britannique — Levallois-Perret
• CHU de Lille, Hôpital Huriez — Lille
• CHU Dupuytren — Limoges
• CHU de Nantes - Hôtel Dieu — Nantes
• AP-HP - Hôpital Cochin — Paris
• Hôpital Lyon Sud — Pierre-Bénite
• CHU de Poitiers — Poitiers
• … и ещё 2 центра

Идентификаторы

NCT: NCT07055191 · 2022_0509 · PHRC-21-0340 · 2022-A02301-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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