NCT02205307终止不适用
A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
Novadaq Technologies ULC, now a part of Stryker27 个研究点 分布在 1 个国家目标入组 347 人开始时间: 2015年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 347
- 试验地点
- 27
- 主要终点
- Anastomotic Leak Rate
研究概览
简要总结
This is a randomized, controlled, parallel, multicenter study to determine the difference in post-operative anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.
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
- None
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
- •Be 18 years of age or older.
- •Be undergoing open, or minimally invasive LAR for the treatment of a rectal or rectosigmoid neoplasm (Subjects with rectal or rectosigmoid neoplasm(s) may be treated with or without neoadjuvant therapy. Long-course neoadjuvant therapy must have been completed ≥6 weeks prior to LAR surgery (Day 0).
- •Have a planned low circular stapled or transanally hand sewn anastomosis ≤10 cm from the anal verge.
- •Have a colorectal or coloanal reconstruction with or without reservoir/pouch.
- •Subjects who are women of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at Day
- •Have signed an approved informed consent form for the study.
- •Be willing to comply with the protocol.
排除标准
- •Undergoing stapled anastomosis with the use of an experimental or non-FDA approved stapler.
- •Undergoing ileoanal reconstruction, total colectomy or proctocolectomy, abdominoperineal resection, Hartmann's procedure, Hartmann's reversal or multiple synchronous colon resections (e.g., LAR and concomitant right colectomy).
- •Has received and completed a course of pelvic radiotherapy ≥ 6 months prior to LAR surgery (Day 0).
- •Has previously undergone a left sided colon resection.
- •Has previously undergone a rectal resection.
- •Has recurrent rectal or rectosigmoid cancer.
- •Has a diagnosis of locally advanced rectal or rectosigmoid cancer undergoing extended en bloc operations.
- •Has a diagnosis of Stage IV rectal or rectosigmoid cancer with any multifocal metastases or single site metastasis with tumor size of > 2 cm (Intraoperative incidental finding or preoperative suspicion of Stage IV cancer with isolated (single site) metastasis (≤ 2 cm) or limited metastases (≤3), with largest lesion ≤ 2 cm in size, does not exclude the subject).
- •Has a diagnosis of inflammatory bowel disease (IBD). Subjects with rectal or rectosigmoid cancer neoplasms and IBD are excluded.
- •Has hepatic dysfunction defined as Model for End-Stage Liver Disease (MELD) Score >
- •Renal dysfunction defined as creatinine ≥ 2.0 mg/dL.
- •Has known allergy or history of adverse reaction to ICG, iodine or iodine dyes.
- •Has, in the Investigator's opinion, any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results.
- •Is actively participating in another investigational clinical study which, in the Investigator's or Sponsor's opinion, would interfere in this study.
结局指标
主要结局
Anastomotic Leak Rate
时间窗: Day 0 to Week 8 (+/- 2 weeks)
Anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT Endoscopic Fluorescence imaging or SPY Elite imaging as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.
次要结局
- Incidence of Post-Operative Abscess Requiring Surgical Management(Day 0 to Week 8 (+/- 2 weeks))
- Rate of SPY Visualization and Tissue Perfusion(Day 0 (Day of Surgery))
研究者
研究点 (27)
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