The Value of Objective Perfusion Rate Assessment by Near-infrared Fluorescence During Restorative Ileal Pouch Formation and Ileal-pouch-anal Anastomosis
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- anastomotic leak
研究概览
简要总结
In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at three time points during ileal pouch reconstruction. Postoperatively, a detailed software-based assessment of each pouch recording is performed to determine the objective ICG-NIRF perfusion rate, which is then correlated with the 30 day postoperative clinical outcome including occurrence of anastomotic leak of the pouch.
详细描述
Near-infrared-fluorescence by indocyanine green (ICG-NIRF) utilises the fluorescent property of intravenously injected indocyanine green (ICG) as an intravascular indicator of tissue and bowel perfusion.
The investigators hypothesise that ICG-NIRF is a suitable, reliable and precise method of visualisation of the blood supply and bowel perfusion in the area of ileal pouch formation and the ileal pouch-anal anastomosis.
In this prospective, non-randomized cohort study, restorative proctocolectomy with ileal pouch reconstruction and ileal pouch-anal anastomosis is performed according to standard of care for medically-refractory ulcerative colitis (UC), UC-associated neoplasia, medically-refractory Crohn´s colitis, colorectal carcinoma or familial adenomatous polyposis (FAP) in open or laparoscopic surgery, according to the surgeon's choice.
Written informed consent for participation and ICG-administration is obtained one day before surgery.
Intraoperatively, Indocyanine Green (ICG, VerDye, Diagnostic Green GmbH, Aschheim Germany, 25 mg vials) is dissolved in 5 mL sterile water to yield a 5 mg/mL concentration. It will then be administered intravenously at three consecutive time points as a bolus of 2 ml per time point at the most. The overall dose of ICG will amount to no more than 30mg of ICG per patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •capability of signing the informed consent
- •diagnosis of therapy resistent ulcerative colitis, colorectal cancer, Crohn's disease, familial adenomatous polyposis
- •restorative proctocolectomy (RPC) with reconstruction through ileal pouch formation and ileal pouch-anal anastomosis (IPAA) is possible and medically indicated
- •ASA (American Society of Anesthesiologists) Physical Status Classification System score ≤ 3
排除标准
- •coexistent malignant tumor of a different ethology
- •liver disfunction (MELD score > 10)
- •ICG (indocyanine green) specific exclusion criteria as per literature (intolerance to indocyanine green or sodium iodide, iodine allergy, hyperthyroidism, autonomous thyroid adenoma, focal or diffuse autonomies of the thyroid, previously badly tolerated injection of ICG)
- •pregnancy or breastfeeding
结局指标
主要结局
anastomotic leak
时间窗: 30 days
occurence anastomotic leak within 30 days of operation
次要结局
- Length of post-operative hospital stay(100 days)
- Operative and post-operative complications(30 days)
研究者
Benjamin Weixler
Attending Physician, Assistant Professor
Charite University, Berlin, Germany