EUCTR2012-002623-15-IE进行中（未招募）1 期
GLiSten: Next generation intraoperative lymph node staging for stratified colon cancer surgery- Development Phase - GLiSten: 5-ALA in Bowel Cancer Surgery - Development Phase
niversity of Leeds0 个研究点目标入组 52 人开始时间: 2013年3月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Able to give informed consent and willing to follow trial protocol
- •2. Aged over 18
- •3. Patients with cancers of the right and sigmoid colon amenable to laparoscopic resection incorporating D3 lymphadenectomy, as agreed by MDT discussion following histopathological diagnosis and radiological staging. Where possible, the study population will be enriched with locally advanced colon cancers to obtain as much information as possible on 5-ALA FD for lymph node metastases.
- •4. Patients with distant metastatic disease will be eligible, provided laparoscopic resection of the cancer is part of routine clinical care.
- •5. Fit for standard laparoscopic resection
- •6. American Society of Anesthesiologists (ASA) classification = 3
- •7. Normal hepatic and renal function on most recent blood tests (to be within 30 days prior to surgery). For the purposes of the trial a normal hepatic renal function can be defined as:
- •i)Total bilirubin within normal institutional limits,
- •ii) AST/ALT < 2.5 X institutional upper limit of normal
- •ii)GFR > or = 60mls/min/1.73m2 or Creatinine within 10% of upper value for normal institutional limits.
- •Evaluation phase: a separate protocol and application will be submitted
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 26
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •1. Patients with cancers of the transverse and left colon (due to difficulty in defining D3 lymphadenectomy in these anatomical locations)
- •2. Past history of hypersensitivity reactions to 5-ALA or colorimetric dye.
- •3. Acute or chronic porphyria or a family history
- •4. Patients with synchronous colonic or rectal cancer (but not benign polyps)
- •5. Patients with co-existent inflammatory bowel disease, such as Crohn’s disease, ulcerative colitis or active diverticulitis, which may influence the lymphatic uptake of 5-ALA
- •6. Pregnant (positive pregnancy test) or breast feeding. 5-ALA has unknown teratogenic and abortifacient effects.
- •In women of childbearing potential (defined as any female who has experienced menarche and who is not postmenopausal or permanently sterilised e.g. tubal occlusion, hysterectomy, bilateral salpingectomy), a pregnancy test will be performed and evidence of a negative result will be required prior to entry into the study. In females of child bearing potential, or those patients with partners of child bearing potential, trial investigators will advise on appropriate contraception (e.g. barrier method) from the point of registration to 30 days postop.
- •7. Received an investigational medicinal product at any dose within 28 days before registration
- •8. Poorly controlled or serious medical or psychiatric illness that, in the Investigator’s opinion, is likely to interfere with participation and/or compliance in this clinical trial.
- •Where possible, the study population will be enriched with locally advanced colon cancers (CT findings of a T4 tumour, T3 tumours with and extramural depth of > 5mm, as per FOcTROT definition) to obtain as much information as possible on 5ALA for lymph node metastases.
- •Concerns regarding a patient's eligibility can be discussed with the St John's University Hospital Leeds' Research Fellow, or with the Chief Investigator.
- •[Evaluation phase: a separate protocol and application will be submitted]
研究者
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