Safety and Efficacy of Endoscopic Ultrasound-guided RadioFrequency Ablation for the Treatment of Functional and Non-functional Pancreatic NeuroEndocrine Neoplasms: A Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Incidence of adverse events (AEs) after EUS-guided radiofrequency ablation (RFA)
研究概览
简要总结
This study evaluates the possibility and the safety of performing local therapy for Pancreatic neuroendocrine neoplasms (PanNENs) using radiofrequency ablation of the tumor under ultrasonography (EUS) guidance.
详细描述
Pancreatic neuroendocrine neoplasms (PanNENs) are rare, but their incidence has significantly increased in the last decades. The mainstay treatment of PanNENs is surgery, which is associated with a significant benefit in term of survival but also with significant short- and long-term adverse events.
Based on the above data, less invasive alternative therapeutic interventions to avoid short- and long-term adverse events of surgery are needed.
In this context radiofrequency ablation has been reported to be effective in the treatment of these tumors in absence of major adverse events. However, the available studies on the matter are limited by small sample size and lack of standardized criteria for patient selection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For all patients
- •Age ≥18 years and <80 years
- •Signed written informed consent
- •Distance from the main pancreatic duct ≥2mm
- •Able to undergo endoscopic ultrasound examination
- •Homogeneous enhancement at contrast harmonic EUS (CH-EUS)
- •For patients with functional pancreatic neuroendocrine neoplasms (F-PanNENs), almost all insulinomas
- •Definitive diagnosis of a clinical syndrome related to excessive insulin secretion fasting test, insulin blood levels, C-peptide blood levels)
- •Single lesion visualized at CT, and/or MRI, and/or EUS
- •Size < 20mm
- •For patients with non functional pancreatic neuroendocrine neoplasms (NF-PanNENs)
- •EUS fine needle biopsy (FNB) proven NF-PanNENs
- •68Ga-DOTATATE PET/CT positive for a pancreatic lesion and negative for lymph nodes, liver, and other distant metastases
- •Hyper- or Iso-enhancing pattern at MRI and/or CT with negative lymph nodes, liver, and other distant metastases
- •G1 or G2 ≤ 5% on histological examination of EUS-guided biopsy samples utilizing EUS-FNB needles
- •Diameter between 15mm and 25mm,
- •Absence of symptoms
- •Absence of inner calcifications
排除标准
- •For all patients
- •Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP)
- •Use of anticoagulants that cannot be discontinued
- •INR >1.5 or platelet count <50.000
- •Previous inclusion in other studies
- •Pregnancy
- •Minimal distance from the main pancreatic duct <1mm
- •Inability to sign the informed consent
- •Heterogeneous enhancement at contrast harmonic EUS (CH-EUS)
- •For patients with F-PanNENs (almost all insulinomas)
- •Diagnosis work up negative excessive hormone secretion syndrome
- •Multiple lesions visualized at CT, and/or MRI, and/or EUS
- •Size > 20mm
- •For patients with NF-PanNENs
- •G2>5% or G3 on histological examination of EUS-guided biopsy samples
- •Diameter <15 mm and >25 mm
- •Presence of symptoms
- •Presence of calcifications
- •Hypo-enhancing pattern at MRI and/or CT
- •68Ga-DOTATATE PET/CT positive for lymph nodes, liver, and other distant metastasis
- •Diagnosis on multiple endocrine neoplasia type 1 (MEN1) syndrome or Von Hippel Lindau syndrome
- •Previous inclusion in other studies
结局指标
主要结局
Incidence of adverse events (AEs) after EUS-guided radiofrequency ablation (RFA)
时间窗: 1 year
AEs will be classified as procedural when they occur during the procedure; post-procedural when they will occur up to 14 days after the procedure; late when they will occur more than 14 days after the procedure. Minor AEs will be those that need no therapy and have no sequelae (A) or have minor therapy or consequence, including overnight admission (B). Major events include those that require major therapy or hospitalization (24- 48 hours) (C); major therapy, need unplanned increase in level of care, or hospitalization \>48 hours (D); or result in permanent adverse sequelae (E) and death (F).
次要结局
- Rates of secondary surgery(1 year)
研究者
Guido Costamagna
Professor
Catholic University of the Sacred Heart