NL-OMON56976尚未招募不适用
Sentinel node and organ sparing surgery in stage I colon carcinoma (SENTRY trial) - SENTRY
Meander Medisch Centrum0 个研究点目标入组 325 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 325
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Oral and written informed consent (IC)
- •- Aged 18 years and older
- •- Fit for both organ-sparing surgery and colectomy
- •- Pathologically confirmed high-risk T1 or low-risk T2 adenocarcinoma of the
- •colon after R0/R1/Rx endoscopic resection
- •- The resection scar after local excision is expected to be clearly recognized
- •at endoscopy, either by a tattoo or by detecting a scar in the colorectal
- •segment where no other polypectomies were performed
- •High-risk features for T1-T2 colorectal carcinoma are:
- •- Poor differentiation grade or undifferentiated (WHO classification of
- •tumours: exhibits glandular structures in <50%)
- •- Positive tumour budding (tumour budding grade 2-3)
- •- Presence of lymphovascular invasion (The presence of cancer cells within
- •endothelial-lined channels)
排除标准
- •- Lesion located <25cm from the anus based on endoscopic measurement
- •- Distant metastasis
- •- Mucinous or signet ring cell carcinoma
- •- Lynch syndrome
- •- Other primary malignancy treated within 5 years prior to diagnosis of colon
- •cancer, except for curatively treated prostate, breast, skin and cervical cancer
- •- Tumours that comprised >50% of the colon circumference before endoscopic
- •- Tumours involving the ileocaecal valve
- •- Pregnancy, lactation or a planned pregnancy during the course of the study
- •- Known allergy to any of the compounds used for SLN identification (ICG,
- •Iodine or Sodium iodide)
- •- Previous colonic surgery (excluding appendectomy).
- •- Contra-indication for laparoscopic or robotic surgery
- •- Severe kidney- or liver failure
- •- Hyperthyroidism or an autonomously functioning thyroid adenoma
研究者
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