Device to Improve Treatment of Colorectal Cancer Using O2 Dependent Phosphorescen

使用 O2 依赖性磷光改善结直肠癌治疗的装置

• 批准号: 8062992
• 负责人: Jason Matthew Zand
• 金额: $ 22.85万
• 依托单位: SURGISENSE CORPORATION
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-13 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8062992
• 关键词: Abdominal Cavity; Abscess; Alternative Therapies; Anastomosis - action; Animals; Anterior; Blood; Blood flow; Cessation of life; Characteristics; Clinical; Clinical Research; Colon; Colorectal Cancer; Coupling; Custom; Data; Defecation; Devices; Disadvantaged; Drainage procedure; Economic Burden; Ensure; Evaluation; Excision; Extravasation; Failure; Family suidae; Feedback; Fluorescence; Fright; Gastrointestinal Surgical Procedures; Grant; Health Care Costs; Healthcare Systems; Injectable; Injection of therapeutic agent; Intestines; Ischemia; Measurement; Measures; Methods; Miniaturization; Modality; Monitor; Morbidity - disease rate; Multi-Institutional Clinical Trial; Multicenter Studies; Observational Study; Operative Surgical Procedures; Ostomy; Outcome; Oxygen; Oxygen Consumption; Oxygen saturation measurement; Pain; Patients; Performance; Perfusion; Phase; Procedures; Property; Reaction Time; Rectal Cancer; Recurrence; Reporting; Research; Risk; Sepsis; Series; Side; Site; Standardization; Stomas; Surface; Surgeon; Surgical Staplers; Surgical Staples; Surgical Stapling; System; Techniques; Testing; Time; Tissue Sample; Tissue Viability; Tissues; Validation; Venous; Work; abdominal wall; abstracting; base; commercialization; cost; design; dosage; improved; in vivo; instrument; interest; luminescence; miniaturize; mortality; multimodality; phase 1 study; phosphorescence; preclinical evaluation; pressure; prevent; sensor; time use; tissue oxygenation; tumor

DESCRIPTION (provided by applicant): Anastomotic failure is one of the most feared complications of gastrointestinal surgery due to the resultant morbidity and mortality. Failure of an anastomosis, or intestinal junction, can cause a spectrum of morbidities to the patient including local abscess formation - requiring procedural drainage, tumor recurrence, debilitating pain, dysfunctional defecation, and overwhelming bacterial sepsis resulting in death. Despite improvements in surgical technique, and the widely accepted use of surgical staplers, anastomotic failure in the form of leakage or stricture occurs at unacceptable high levels given the severe consequences. In the performance of a low anterior resection (LAR) for excision of rectal cancer, anastomotic failure has been reported to occur in up to 30% of cases. One large multicenter, observational study of 2729 patients reported a leak rate of 14.3%. These anastomotic failures cause a significant and avoidable economic burden on the healthcare system, as well as an incalculable amount of pain, suffering, and hardship for the patients in which the failure occurs. As a precaution many surgeons will tunnel a proximal segment of the bowel through the abdominal wall to form a diverting stoma. The rationale of this maneuver is to prevent the leakage of fecal matter into the abdominal cavity from a potential failure at the newly formed anastomotic site. Many times the surgeons will perform another procedure to reverse the stoma months after the initial procedure. In the same multicenter study 881 patients were given a temporary diverting stoma to mitigate the risk of an anastomotic leak, however, within this group only 128 patients developed a leak. Thus up to 85% of those patients underwent an additional surgical procedure to reverse the stoma that provided questionable benefit. The arbitrary creation of a temporary diverting stoma, and the eventual reversing procedure presents a significant and avoidable economic burden on the healthcare system, as well as exposes numerous patients to arguably unnecessary surgical risk. Presently, there is neither a clinically practical method nor device available for predicting anastomotic failure, nor objective criteria by which the operative team can decide when a diverting stoma is indicated. Our objective is to create a clinically transparent device that reduces anastomotic failures through analysis of target tissues before, during, and after creation of an anastomosis. If the tissues are deemed unsuitable for reliable formation of an anastomosis, the device alerts the operative team to take corrective action. Our approach is to design a device that: integrates into the surgical workflow by coupling to a commercially available, off-the-shelf surgical stapling instrument, employs an array of multimodality sensors to assess the viability of the tissues at the staple line, and wirelessly transmits sensor data to a base station where the real-time feedback is displayed to the operative team. Phase I of this study will focus on the evaluation of in-vivo oxygen dependent quenching of phosphorescence as the primary modality capable of assessing tissue viability, while maintaining clinical and commercial feasibility. PUBLIC HEALTH RELEVANCE: The proposed research is the first step to realizing a clinically transparent device capable of providing real-time assessment of anastomotic viability not currently available to the operative team; the operative team will be able to take appropriate measures to reduce anastomotic failures by ensuring adequate tissue perfusion. The proposed device will assist the operative team by objectively determining the optimal staple gap, minimizing tension across the anastomosis, and indicating when the creation of a diverting ostomy or the provision of an alternative therapy is in the best interest of the patient. The proposed device could significantly reduce patient suffering, while saving $2 billion dollars annually in excess healthcare costs.

描述（申请人提供）：吻合口失败是胃肠道手术中最可怕的并发症之一，其发病率和死亡率都很高。吻合或肠结的失败可引起患者的一系列疾病，包括局部脓肿形成（需要手术引流）、肿瘤复发、衰弱性疼痛、排便功能障碍和导致死亡的压倒性细菌性败血症。尽管手术技术有了进步，外科吻合器的使用也得到了广泛的接受，但由于严重的后果，吻合口瘘或狭窄的发生率很高，令人无法接受。在低位前切除术（LAR）切除直肠癌的执行中，据报道在高达30%的病例中发生吻合口衰竭。一项涉及2729例患者的大型多中心观察性研究报告了14.3%的泄漏率。这些吻合失败给医疗保健系统造成了重大的、可避免的经济负担，同时也给发生吻合失败的患者带来了无法估量的痛苦、折磨和困难。作为预防措施，许多外科医生将肠的近端段穿过腹壁形成一个转移口。这种操作的基本原理是为了防止由于新形成的吻合口的潜在失败而导致粪便渗漏到腹腔。很多时候，外科医生会在初次手术几个月后进行另一次手术来逆转造口。在同一项多中心研究中，881例患者接受临时转移造口以减轻吻合口漏的风险，然而，在该组中只有128例患者发生了吻合口漏。因此，高达85%的患者接受了额外的外科手术来逆转成形术，但效果尚存疑问。临时转移造口的任意创建，以及最终的逆转手术对医疗保健系统造成了重大而可避免的经济负担，并使许多患者面临不必要的手术风险。目前，临床上既没有一种实用的方法和设备来预测吻合口衰竭，也没有客观的标准来决定手术团队何时需要转移造口。我们的目标是创造一种临床透明的设备，通过在吻合之前，期间和之后对目标组织的分析来减少吻合失败。如果组织被认为不适合可靠地形成吻合，该装置会提醒手术小组采取纠正措施。我们的方法是设计一种设备：通过与市售的、现成的外科吻合器耦合，将其集成到手术工作流程中，采用一系列多模态传感器来评估钉线处组织的生存能力，并将传感器数据无线传输到基站，在基站上实时反馈给手术团队。本研究的第一阶段将重点评估体内氧依赖性磷光猝灭作为评估组织活力的主要方式，同时保持临床和商业可行性。