Resection of the Primary Tumor vs. Systemic Treatment Alone for Patients With Small Intestinal Neuroendocrine Tumors and Unresectable Metastases: a Retrospective, Europe-wide, Pooled Cohort Study (ENETS-SurgSmInt)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,200
- 试验地点
- 1
- 主要终点
- To evaluate the 10-year overall survival of non-curative metastatic siNET with or without primary tumor resection at initial diagnosis in asymptomatic patients.
研究概览
简要总结
When possible, surgery to completely remove small intestinal neuroendocrine tumors (siNETs) is always recommended. However, in cases where the tumor has spread and cannot be cured completely, it is unclear whether a surgical removal of the primary tumor only is reasonable. In this situation, current guidelines from the European Neuroendocrine Tumor Society (ENETS) recommend surgery only for patients who have symptoms like intestinal blockage or bleeding, or are at risk of such complications. For patients without symptoms, it is still unclear whether removing the main tumor improves overall outcomes and prevents future problems.
Studies evaluating this type of surgery on survival show conflicting results. These studies often do not separate patients with symptoms from those without, and they overlook other important factors like the amount of cancer in the liver and nearby tissues. Due to these uncertainties, the rarity of siNETs and many factors that can affect outcomes, like age, overall health, or other current treatments, conducting a high-quality study to answer this question is challenging. To address this, the present Europe-wide study is being planned.
This study aims to determine if resecting the main tumor improves the 10-year overall survival and reduces risks like intestinal blockages or blood flow issues compared to no surgery in patients without symptoms. The study will also assess other outcomes, such as how long patients stay free from disease progression, the risks of surgery, and prognostic factors for long-term survival. This international collaboration among neuroendocrine tumor referral centers will provide robust evidence to guide clinical practice and update treatment guidelines for siNETs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- All patients with siNET and non-curative metastatic disease between 01.01.2005 and 31.12.2021 will be included.
排除标准
- •- All patients with siNET G3, resectable metastatic disease and/or non-resectable primary tumor at initial diagnosis will be excluded. Furthermore, symptomatic patients (small intestinal obstruction, bleeding) or when imaging suggests that obstruction will probably occur (bowel dilatation, mesenteric fibrosis) at initial diagnosis will be excluded. Patients with diarrhea, flushing, or abdominal pain will not be excluded.
- •Patients with a documented rejection for a further use of their data for scientific purposes will also be excluded.
研究组 & 干预措施
Histopathological review
The patients will be grouped according to whether a primary tumor resection within 6 months after initial diagnosis was performed (yes vs. no).
干预措施: Histopathological review (Other)
结局指标
主要结局
To evaluate the 10-year overall survival of non-curative metastatic siNET with or without primary tumor resection at initial diagnosis in asymptomatic patients.
时间窗: 10 years follow-up
For the survival analysis, Kaplan-Meier method will be used to estimate overall survival at 10 years for patients with and without primary tumor resection.
次要结局
- To evaluate the progression-free survival of non-curative metastatic siNET with or without primary tumor resection at initial diagnosis in asymptomatic patients.(10 years follow-up)
- To examine the risk of small intestinal obstruction with or without palliative primary tumor resection(10 years follow-up)
- To examine the risk of small intestinal hypoperfusion with or without palliative primary tumor resection(10 years follow-up)
- To evaluate the morbidity of palliative primary tumor resection(10 years follow-up)
- To evaluate the mortality of palliative primary tumor resection(10 years follow-up)
- To assess prognostic factors for long-term survival(10 years follow-up)