Central Neck Dissection in Patients with Clinical Node Negative Thyroid Cancer

临床淋巴结阴性甲状腺癌患者的中央颈清扫术

• 批准号: 8631519
• 负责人: NADINE P CONNOR
• 金额: $ 37.81万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-01-01 至 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8631519
• 关键词: Address; Adopted; Adoption; Affect; American; Benefits and Risks; Calcium; Cervical lymph node group; Climacteric; Clinical; Clinical Trials; Complication; Consensus; Counseling; Data; Deglutition; Disease; Disease-Free Survival; Dissection; Distant; Evaluation; Evidence based practice; Excision; Expert Opinion; Frequencies; Fright; Future; Guidelines; Head and Neck Cancer; Health; Hormones; Hydration status; Hypocalcemia result; Hypoparathyroidism; Image; Incidence; Intervention; Interview; Investigation; Ipsilateral; Lead; Level of Evidence; Life; Lymph Node Involvement; Malignant Neoplasms; Malignant neoplasm of thyroid; Measures; Monitor; Morbidity - disease rate; Muscle Cramp; Neck; Neck Dissection; Neoplasm Metastasis; Operative Surgical Procedures; Outcome; Papillary thyroid carcinoma; Parathyroid gland; Paresthesia; Patient Care; Patients; Pharmaceutical Preparations; Postoperative Period; Practice Guidelines; Probability; Procedures; Prospective Studies; Quality of life; Randomized; Randomized Clinical Trials; Recommendation; Recurrence; Recurrent disease; Reporting; Research; Rest; Risk; Role; Series; Serum; Solid; Surrogate Markers; Surveys; Symptoms; Testing; Thyroglobulin; Thyroid Diseases; Thyroid Gland; Thyroidectomy; Time; Ultrasonography; United States; Vitamin D; Voice; Work; base; calcium intake; cancer recurrence; clinical care; evidence base; health related quality of life; instrument; knowledge base; lymph nodes; nutrition; prophylactic; prospective; public health relevance; risk benefit ratio; standard care

DESCRIPTION (provided by applicant): The mainstay of therapy for papillary thyroid cancer (PTC) is surgical excision, consisting of total thyroidectomy. Lymph node recurrence following thyroidectomy is a substantial clinical problem. In an attempt to decrease recurrence, prophylactic central neck dissection is often performed along with total thyroidectomy. Based only on expert opinion, current American Thyroid Association (ATA) practice guidelines recommend prophylactic central neck dissection. However, addition of a prophylactic central neck dissection may not be necessary for the majority of patients and may substantially increase postsurgical morbidities of hypocalcemia and deficits in swallowing, communicative function and health-related quality of life (HR-QOL). The probability and extent of these morbidities are currently unknown. Before routine central neck dissection can be adopted as a standard treatment it is important that the true risks and benefits of this procedure are systematically examined. The fact that only expert opinion guides this recommendation argues for the need for a prospective clinical trial to fully evaluate this common and potentially morbid clinical problem. Our hypothesis is that total thyroidectomy with prophylactic central neck dissection results in an increased rate of complications in comparison with total thyroidectomy alone for PTC without an associated benefit to the patient. We will test this hypothesis with a randomized clinical trial in which 140 patients undergoing total thyroidectomy for PTC with no preoperative evidence of distant or cervical lymph node metastasis will be randomized into one of two groups: prophylactic central neck dissection or no central neck dissection. This work has four specific aims in which patients with PTC undergoing total thyroidectomy with central neck dissection will be contrasted with those undergoing total thyroidectomy alone: (1) To determine the rate of transient and persistent hypocalcemia; (2) To determine the rate of voice and swallowing problems; (3) To determine the degree to which HR-QOL is compromised; and, (4) To determine clinical recurrence rates. The results of the proposed research will lead to an increased understanding of the manner in which prophylactic central neck dissection affects critical functions of the head and neck and cancer recurrence in patients with PTC. Due to the potentially serious and pervasive problems encountered in communicative function and swallowing in patients with PTC, it is of great importance to add to this knowledge base, to test interventions, and to lay the groundwork for evidence-based practice, particularly for untested surgical interventions in current use. Our findings have a high likelihood of yielding meaningful findings and solid evidence related to an important clinical issue.

描述（由申请人提供）：乳头状甲状腺癌（PTC）治疗的主要是手术切除，包括全部甲状腺切除术。甲状腺切除术后淋巴结复发是一个重大的临床问题。为了减少复发性，预防性中央颈部解剖通常与总甲状腺切除术一起进行。仅基于专家意见，美国当前的甲状腺协会（ATA）实践指南建议预防中央颈部解剖。但是，对于大多数患者而言，加入预防性中央颈部的剖析可能不需要，并且可能会大大增加吞咽，沟通功能和与健康相关的生活质量（HR-QOL）的低钙血症和缺陷（HR-QOL）。这些病因的概率和程度目前尚不清楚。在常规的中央颈部剖析作为标准治疗之前，必须系统地检查该程序的真正风险和好处。只有专家意见引导该建议的事实证明，需要进行前瞻性临床试验来充分评估这一常见且潜在的病态临床问题。我们的假设是，与单独的甲状腺切除术相比，PTC的总甲状腺切除术和预防性中央颈部解剖会增加并发症的率，而没有对患者的相关益处。我们将通过一项随机临床试验检验这一假设，其中140例接受甲状腺全切除术的患者对PTC进行了PTC，而没有术前或宫颈淋巴结转移的术前证据将被随机分为两组之一：预防性中央颈部颈部剖腹乳头或中央颈部剖腹。这项工作具有四个特定的目的，其中PTC患者接受甲状腺全切除术的全部甲状腺剖分术将与仅接受总甲状腺切除术的患者形成鲜明对比：（1）确定短暂性和持续性低钙症的速度； （2）确定语音和吞咽问题的速度； （3）确定HR-QOL损害的程度；和（4）确定临床复发率。拟议研究的结果将导致人们对预防性中央颈部解剖影响头颈部关键功能以及PTC患者的癌症复发的关键功能的方式增加理解。由于PTC患者在交流功能和吞咽中遇到的潜在严重和普遍的问题，添加此知识库，测试干预措施并为基于证据的实践奠定基础，特别是对于未经测试的手术干预措施，非常重要。我们的发现很有可能产生有意义的发现和与重要临床问题有关的可靠证据。