NCT05138094招募中不适用
LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection
Fondazione Poliambulanza Istituto Ospedaliero55 个研究点 分布在 10 个国家目标入组 82 人开始时间: 2021年8月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 55
- 主要终点
- Time to functional recovery
研究概览
简要总结
The LIVACOR - Trial is a European wide, randomized controlled, open-label, multicenter trial. Patients with synchronous colorectal liver metastases (CRLMs) and primary colorectal tumor are considered eligible and will be randomized between minimally invasive (MI) combined or staged colorectal resection (all colectomies, including high anterior resection) and liver resection of up to three segments.
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
- •≥ 18 years
- •Diagnosed with primary CRC with resectable synchronous CRLMs (with or without neoadjuvant chemotherapy)*
- •Elective indication for MI combined or staged colorectal resection (all colectomies, including high anterior resection) and liver resection of up to 3 segments with a maximum of 2 separate liver resections. The MI two-staged approach includes both the conventional strategy (first resection of primary colorectal tumor followed by liver resection for CRLMs) and liver-first strategy (first CRLMs resection followed by resection of colorectal primary tumor). Patients undergoing bilobar resections are eligible (if 3 or fewer segments are resected)
- •BMI between and including 18-35
- •Patients with American Society of Anesthesiologists (ASA) physical status I-III and the American College of Surgeons national surgical quality improvement project (ACS NSQIP) universal surgical risk score of ≤ 50% for serious complications
- •In case of neoadjuvant chemotherapy, time interval between last chemotherapy cycle and (first) surgery should be 4-6 weeks.
排除标准
- •Inability to give (written) informed consent.
- •Patients requiring a planned temporarily or permanent stoma after colorectal resection (all colectomies, including high anterior resection). Patients who will receive an unplanned stoma intraoperatively, will be analysed according to their initial treatment assignment.
- •Patients requiring multivisceral colorectal resection (all colectomies, including high anterior resection).
- •Indication for MI combined or staged low anterior resection, total mesorectal excision or abdominoperineal resection and liver resection of four or more segments (i.e., hemihepatectomy or more extensive resections).
- •Patients with peritoneal metastases.
- •Patients with ASA physical status IV-V and ACS NSQIP surgical risk score of > 50% for serious complications.
- •Repeat open hepatectomy
- •Surgical history of colorectal- or liver resection for neoplastic disease
- •Surgical history of major or complicated open abdominal surgery
- •Indication for concurrent thermal ablation
- •Medical history of thermal ablation of liver for malignancy
- •Unresectable extrahepatic metastases
- •Pre-operatively reconstruction of vessels/bile ducts is deemed necessary
结局指标
主要结局
Time to functional recovery
时间窗: Expected average of 4 to 12 days postoperatively
A patient is considered functionally recovered from a surgical procedure when several pre-specified criteria have been met.
次要结局
- Intraoperative blood loss(During the surgical procedure)
- R0 resection margin(30 days postoperatively)
- Length of hospital stay(30 days postoperatively)
- Activity tracking using Fitbit™(14 days pre-operatively and 60 days postoperatively)
- Reasons for delay of discharge after functional recovery(30 days postoperatively)
- Hospital and societal costs(1 year postoperatively)
- Three and five-year recurrence free survival(5 years postoperatively)
- Operative time(Operative time from incision until last suture)
- Morbidity(90-days postoperatively)
- Conversion to open surgery(During the surgical procedure)
- Readmission rate(90-days postoperatively)
- Health-Related Quality of Life(1 year postoperatively)
- Three and five-year overall survival(5 years postoperatively)
- Postoperative bile leakage(90-days postoperatively)
- Postoperative anastomotic leakage(90-days postoperatively)
研究者
研究点 (55)
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