跳至主要内容
临床试验/NCT03442959
NCT03442959招募中不适用

Resection of the Primary Tumor vs no Resection in Asymptomatic Patients With Unresectable Synchronous Liver Metastases From siNEN

CHU de Reims1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年7月3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
CHU de Reims
入组人数
50
试验地点
1
主要终点
Death

研究概览

简要总结

Small Intestinal neuroendocrine Tumors (SiNETs) incidence is rising. Most of siNETs primaries are localized in jejunum/ileum. At the diagnosis, 50-70% of them present either lymph node (LN) and/or liver metastases (LM). It is admitted that almost 30% of the patients present or will present primary complications. Primary complications include endoluminal obstruction and/or LN-fibrotic mesenteritis with occlusive symptoms, and less frequently haemorrhage and/or intestinal ischemia.However, it is not clear weather this affects patient with or without multiple liver metastases (LM). In this regard, many centres propose to perform primary resection even in patients presenting unresectable LM. Thus, systemic reviews suggest a possible benefit of the primary midgut siNETs resection even in patients with unresectable LM, there is no prospective randomized trial showing the benefit of primary resection in such patients especially those who are totally asymptomatic. Indeed, all retrospective published series have several limitations and the results should be therefore considered with caution.

Theoretical impact of "preventive" resection of midgut primaries in patients with unresectable LM and totally free of occlusive symptoms is controversial. Firstly, it is to avoid primary mechanical complications, and secondly to allow targeting therapeutics to the liver compartment. In this regard, in patients with synchronous unresectable LM from siNENs, ENETS, UKINETS, NANETS guidelines propose, in "a case-by-case" selective approach, the resection of the primary, while NCCN guidelines advocate to do not propose primary resection in such patient if they are free of symptoms with low tumor burden.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years old
  • Patient with Si-NET and liver metastases considered as non-resectable
  • Primary-related "asymptomatic" patient at diagnosis
  • Diagnosed during the past 6 months
  • No symptoms in relation with the primary or with mesenteric lesions
  • Symptoms related to carcinoid syndrome allowed

排除标准

  • 未提供

结局指标

主要结局

Death

时间窗: 5 years

Death due to Small Intestinal neuroendocrine Tumor

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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