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临床试验/NCT00765791
NCT00765791已完成不适用

2B or Not 2B? Shoulder Function After Level 2B Neck Dissection: A Randomized Controlled

University of Alberta2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Change in Neck Dissection Impairment Index (NDII) score from pre- to post-op.

研究概览

简要总结

Many types of head and neck cancers will have local spread to the neck. As such selective neck dissection is performed as part of the treatment. The neck is divided into various levels. Selective neck dissection targets areas that are most likely to harbor cancer cells for specific types of head and neck cancers. Level IIB has been particularly controversial in the last few years, as the rate of cancer spread to this area has been shown to be quite low (0-8%). Moreover, because the spinal accessory nerve (involved in shoulder function) runs through this area, there is theoretical risk of causing post-operative shoulder weakness. As such, the question of whether removing level IIB, knowing that there is low chance of it containing disease spread, is worth risking decreased shoulder function. Some would argue that all potential diseased sites should be removed at all costs. While other advocate that a balance between disease cure and function should be maintained. However, what needs to be determined is just what impact does dissecting IIB have on shoulder function. At our institution, the rate of poor shoulder function associated with selective neck dissection has been perceived as being quite low. This study is designed to test this observation.

Hypothesis: Neck dissection including level IIb in head and neck cancer patients will not lead to worse shoulder function and quality of life than when level IIb is preserved.

详细描述

The lymphatic fluid of upper aerodigestive tract (UADT) drains into various levels of the neck. When cancer occurs in the UADT, the potential for local metastatic spread to the neck exists, thus necessitating treatment of the neck. Ideally all potential neck structures, which could harbor cancer cells or provide a dock for recurrence, would be eradicated. Unfortunately, such radical treatments have shown to cause extreme rates of morbidity with little extra oncologic benefit. Thus, head and neck oncologists have strived to create treatment paradigms, which maximize cure rates while minimizing morbidity. Finding this intricate balance has translated to selective neck dissection (SND) and post-operative RT.1

Increased understanding of lymphatic drainage patterns in the head and neck has lead to widespread use of SND. Through removal of lymphatics in neck levels with the highest risk of harboring cancer cells, based on primary tumor site, important neck structures may be preserved. As such, the treatment remains oncologically sound and avoids the morbidity associated with its predecessor, the radical neck dissection. 1

One of the structures preserved in the SND is the spinal accessory nerve (SAN), which is responsible for providing motor innervation to the sternocleidomastoid (SCM) and trapezius muscles. Thus, it is intricately involved in shoulder function. The nerve exists the skull base at the jugular foramen and obliquely passes through neck level II. It then passes posterior to the SCM and eventually enters the trapezius muscles. Through this trajectory, it divides level II into IIa (anterior to the SAN) and IIb (posterior to the SAN).

It is known that shoulder function significantly deteriorates when level V is dissected.2 This is likely due to traction and devascularization injury of the longest portion of the SAN in the neck. As such, practice has become such that level V is left intact in cases where it does not harbor detectable disease or when occult disease incidence is very low. Due to the intimate relationship of IIb with the SAN, there is also potential for injury to the nerve in this area.2 As such, debate has arisen to the necessity of including IIb in the neck dissection specimen. Studies have shown that the prevalence of occult nodal disease in IIb ranges from 0-8.7.5% depending on the overall n stage of the neck.3-5 These figures have lead head and neck surgeons to weigh the benefits of not excising lymphatic tissue with low nodal metastatic rates versus excising the area and decreasing post-operative shoulder function.6

Because the incidence of occult metastases in IIb is low3-5, it has become standard of care in many centers to spare IIb, if it is oncologically feasible, in SND to preserve shoulder function. Because these patients receive post-operative RT it is thought that the RT will address any occult disease. Unfortunately, relying on RT poses two problems:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Head and neck cancer to be treated with primary surgical resection, SND and post-operative radiation therapy (RT).
  • N0 neck disease on side of the dominant hand
  • Willingness to participate in post-operative physiotherapy

排除标准

  • IIb positive disease found on clinical exam, CT Scan or intraoperatively (gross appearance or positive margins of frozen section of level IIa)
  • Previous neck RT
  • Previous chemotherapy
  • Invasion of spinal accessory nerve (SAN) by neck malignancy (evident on physical exam, CT scan or intraoperatively (gross appearance).
  • Previous neck dissection
  • Previous SAN injury or dysfunction
  • Preoperative signs or formal diagnosis of myopathy or neuropathy
  • Previous shoulder injury (muscular or bony)
  • Level V neck dissection
  • Recognized intraoperative sectioning of the SAN
  • Unable to provide informed consent
  • Cardiac pacemaker (contra-indication to EMG/Nerve conduction)
  • Radial forearm free flap on dominant arm

结局指标

主要结局

Change in Neck Dissection Impairment Index (NDII) score from pre- to post-op.

时间窗: 6 months per patient

次要结局

  • Shoulder strength, range of motion and electromyographic (EMG)/nerve conduction testing(6 months per patients)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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