Randomized Trial of EUS Neurolysis in Pancreas Cancer

EUS 神经溶解术治疗胰腺癌的随机试验

• 批准号: 6969073
• 负责人: MICHAEL Bradley WALLACE
• 金额: $ 14.14万
• 依托单位: MAYO CLINIC JACKSONVILLE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-08-20 至 2007-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6969073
• 关键词: analgesia; biopsy; clinical research; clinical trials; drug administration rate /duration; drug adverse effect; endoscopy; human subject; human therapy evaluation; image guided surgery /therapy; narcotics; neoplasm /cancer classification /staging; pancreas neoplasms; patient oriented research; quality of life; ultrasound

DESCRIPTION (provided by applicant): This a randomized, double-blind, sham-controlled trial to determine the effectiveness of celiac plexus neurolysis (CRN) as an adjunct to standard medical therapy for pain control in patients with unresectable pancreatic cancer and moderate to severe pain. Nearly 100% of patients with pancreatic cancer experience pain. Despite the availability of narcotic analgesics, up to 50% of patients have poorly controlled pain. A 1993 randomized placebo-controlled trial of surgical CRN, performed at the time of exploratory laparotomy, demonstrated CRN to be safe and effective. Recent advances in imaging methods (CT, MRI, EUS) have allowed better pre-operative identification of patients with unresectable disease, such that patients rarely require exploratory laparotomy. For this reason a minimally invasive method of pain control in pancreatic cancer which could be performed in conjunction with staging and tissue confirmation, would be a major clinical advance. Endoscopic ultrasound is a widely used, minimally invasive, highly accurate and safe method of staging, and tissue biopsy of pancreatic cancer. Phase II, uncontrolled trials suggest that EUS is also capable of delivering effective celiac plexus neurolysis (EUS-CPN). To date, there are no published controlled trials or EUS-CPN. This study will enroll patients who are undergoing diagnostic EUS-FNA procedures for staging of pancreatic cancer. Those found to be unresectable would be randomized "intra-op" to either sham or real EUS-CPN. Outcomes will include pain scores, quality of life, narcotic use and survival. The primary outcome will be a reduction in pain at 1 month. Secondary outcomes will include the durability of pain control, quality of life, narcotic use and narcotic side effects.

描述（由申请人提供）：这是一项随机、双盲、假对照试验，旨在确定腹腔神经丛神经松解术 (CRN) 作为标准药物治疗的辅助疗法对不可切除的胰腺癌和中度至重度疼痛患者的疼痛控制的有效性。近 100% 的胰腺癌患者都会经历疼痛。尽管有麻醉镇痛药，但高达 50% 的患者疼痛控制不佳。 1993 年在剖腹探查时进行的一项手术 CRN 随机安慰剂对照试验证明 CRN 安全有效。影像学方法（CT、MRI、EUS）的最新进展使得能够在术前更好地识别患有不可切除疾病的患者，因此患者很少需要剖腹探查术。因此，可以与分期和组织确认结合进行的胰腺癌疼痛控制的微创方法将是一项重大的临床进步。超声内镜是一种广泛使用的、微创的、高度准确且安全的胰腺癌分期和组织活检方法。 II 期非对照试验表明 EUS 还能够提供有效的腹腔神经丛神经松解术 (EUS-CPN)。迄今为止，还没有已发表的对照试验或 EUS-CPN。这项研究将招募正在接受诊断性 EUS-FNA 手术以进行胰腺癌分期的患者。那些被发现无法切除的患者将在“术中”随机分配到假手术或真正的 EUS-CPN。结果将包括疼痛评分、生活质量、麻醉品使用和生存。主要结果是 1 个月时疼痛减轻。次要结果包括疼痛控制的持久性、生活质量、麻醉品使用和麻醉品副作用。