2024-518783-13-00招募中2 期
Indocyanine green to assess vascularity of ileal conduit anastomosis and regulate ureteral resection margins during pelvic exenteration for recurrent/persistent gynecological cancer. A pilot study
Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年11月25日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- the overall rate of benign uretero-enteric stricture
研究概览
简要总结
to assess the vascularity of ileal conduit UD in patients undergoing ICG perfusion-modulated resection of ureters undergoing ileal conduit
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, and < 75 years
- •Cervical/vulvar/vaginal/endometrial cancer recurrence/progression or persistence suitable for pelvic exenteration histologically confirmed
- •Estimated life expectancy of at least 4 weeks
- •Signed written informed consent
排除标准
- •Hypersensitivity to indocyanine green, to sodium iodide or to iodine
- •Subjects who are employed by or otherwise dependent on the sponsor or the investigator may not be enrolled in the study
- •Patients affected by hyperthyroidism, or with autoimmune thyroid adenomas
- •Severe kidney failure (eGFR <30ml/min/1,73m2)
- •Patients undergoing only posterior pelvic exenteration
- •Patients undergoing ureterostomy
- •Patients who underwent previous ureteral surgery (open, endoscopic or minimally invasive)
- •Refusal to sign written informed consent
- •Any clinical condition, which in the opinion of the investigator, places the subject at risk, prevents the subject from fully participating in the trial procedures, or potentially impairs the quality of the trial data
- •Participation in a clinical study in which an investigational drug was administered within 30 days or 5 half-lives before the ICG administration, whichever is longer
结局指标
主要结局
the overall rate of benign uretero-enteric stricture
the overall rate of benign uretero-enteric stricture
次要结局
- Rate of Clavien Dindo grade three and four post-operative complications, both early (within 30 days after surgery) and late (from day 31 to day 180 after surgery)
- To assess the overall rate of ureteric leak in the study sample
- To assess the differences in eGFR (i.e., renal function) over time (baseline, 1, 3 and 6 months) according to fluorescence levels
- To assess 12-months overall survival (OS) and progression free survival (PFS)
研究者
Nicolò Bizzarri
Scientific
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
研究点 (1)
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