Thyroidectomy for Graves' Disease or Amiodarone-induced Thyrotoxicosis: Is it Still Necessary to Achieve a Preoperative Euthyroid State? - A Prospective Observational Multicenter European Study (GRATES)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 486
- 试验地点
- 15
- 主要终点
- Complications
研究概览
简要总结
The goal of this observational study is to learn about the potential differences in morbidity of thyroidectomy (removal of the thyroid gland) depending on the preoperative hormonal status. The main question it aims to answer is:
Do patients undergoing thyroidectomy for thyreotoxicosis (thyroid hyperfunction) due to Graves' disease or Amiodarone induced thyreotoxicosis have comparable complication rates depending on their thyroid metabolic status prior or during the procedure.
The data from participants undergoing a thyroidectomy at one of the study sites will be prospectively registered in the EUROCRINE registry, including an add-on module for additional study specific routine data. The operation itself, the preoperative or postoperative treatments are not altered in any way.
详细描述
Background:
Thyrotoxicosis is the clinical condition associated with excessive thyroid hormone activity, usually due to inappropriately high levels of circulating thyroid hormones. The clinical presentation is variable, ranging from asymptomatic to life-threatening 'thyroid storm'. Symptoms include weight loss, heat intolerance and palpitations. Thyrotoxicosis can result from diffuse alterations of the thyroid gland, such as Graves' disease and Amiodarone-induced thyrotoxicosis (AIT). This poses a considerable challenge across multiple medical specialties, spanning endocrinology, cardiology, and anesthesiology.
Graves' disease is a widespread endocrine disorder that affects approximately 1% of the population. Treatment strategies vary based on clinical presentation and patient preferences, with options ranging from medical management to thyroidectomy. Amiodarone is a class III antiarrhythmic drug used to treat supraventricular and ventricular arrhythmias, and to maintain sinus rhythms after cardioversion of atrial fibrillation. Its prescription has become more common in recent decades. However, the medication comes with the risk of precipitating severe thyrotoxicosis, which, if left untreated, can be fatal. Discontinuing the medication may not always be feasible.
Under medical treatment for thyrotoxicosis (using thionamides or glucocorticoids), attaining euthyroidism can frequently be challenging to achieve, prompting consideration of definitive treatment through thyroidectomy.
Thyroidectomy for Graves' disease or AIT presents unique disease-specific challenges, potentially resulting in elevated perioperative complication rates when compared to other indications. According to current guidelines, it is recommended to attain a euthyroid state prior to surgery to mitigate perioperative risks, despite the inconclusive evidence supporting this approach. Nevertheless, data from retrospective studies show that between 21-51% of patients undergo surgery when euthyroidism is not stable or cannot be achieved.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥ 18 years of age) undergoing surgical treatment for Graves' disease or Amiodarone-induced thyrotoxicosis (AIT) with biochemically confirmed hyperthyroidism or on specific medication for the treatment of Graves' disease or AIT.
- •Patients providing signed informed consent.
排除标准
- •Children and minors (<18 years).
- •Pregnant women.
- •Patients unable or unwilling to provide informed consent due to language barriers or intellectual limitations.
- •Patients undergoing concurrent parathyroidectomy for primary or secondary hyperparathyroidism, lymph node clearance, or redo surgery.
- •Surgical procedures performed for other reasons than Graves' disease or AIT
结局指标
主要结局
Complications
时间窗: Day 0= intraoperative until last follow-up postoperatively (e.g. for the recovery from a nerve palsy)= through study completion, an average of 2 years
transient and permanent nerve palsy, transient and permanent hypoparathyroidism, reoperation for postoperative hemorrhage, occurrence of a "thyroid storm"
次要结局
- Duration of Surgery(through study completion, an average of 2 years)
- Estimated Blood Loss(During procedure)
- Intraoperative Tachycardia(During the procedure)
- Angiofluorescence(During the procedure)
- Neuromonitoring(During the procedure)
- Preoperative Calcium or Vitamin D supplementation(Preoperative Study Period)
- Clinic Volume(Baseline)
- Other complications(From day 0= intraoperatively until last follow-up postoperatively (= through study completion, an average of 2 years))
- Lenght of Hospital Stay(From day 0= intraoperatively until last follow-up postoperatively (= through study completion, an average of 2 years))
- ICU monitoring(From day 0= intraoperatively until last follow-up postoperatively (= through study completion, an average of 2 years))
- Preoperative Medications(From day 0= intraoperatively and prior records (after study inclusion=baseline))
- Autofluorescence(During the procedure)
研究者
Andrea Goldmann
Fellow of the European Board of Surgery (FEBS) - Endocrine Surgery, Schwerpunkt Viszeralchirurgie, FMH Chirurgie, Kantonsspital Winterthur Klinik für Viszeral- und Thoraxchirurgie Stv. Chefärztin und Stv. Klinikleiterin, Teamleiterin Endokrine Chirurgie
Kantonsspital Winterthur KSW