Endoscopic Ultrasound-guided RAdiofrequency Ablation Versus Surgical Resection for the Treatment of Pancreatic INsulinoma: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rate of adverse events
研究概览
简要总结
The goal of this muticentre randomized controlled trial is to compare endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) with surgery for treatment of pancreatic insulinoma. The main questions it aims to answer are: 1) What is the safest treatment? 2) Is efficacy comparable? Patients will be randomized to undergo EUS-RFA or surgical resection. Researchers will compare the rate of adverse events and the clinical efficacy after the two treatments to see if EUS-RFA result safer and effective compare with surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Diagnosis of pancreatic insulinoma (38) (e.g., fasting test, insulin blood levels, C-peptide blood levels)
- •Presence of a visible single pancreatic nodule on imaging (computed tomography, and/or magnetic resonance imaging, and/or endoscopic ultrasound).
- •No evidence of distant localizations visualized at computed tomography, and/or magnetic resonance imaging, and/or endoscopic ultrasound
- •Tumor ≤ 2cm
- •Informed consent provided by the patient or closest relative.
排除标准
- •G2 with Ki-67 >5% on histological examination at EUS-guided biopsy samples (if performed)
- •Distance between lesion and main pancreatic duct ≤ 1mm or upstream dilation of the main pancreatic duct
- •Metastatic tumor at the time of diagnosis
- •Multiple pancreatic nodules
- •Diagnosis of multiple endocrine neoplasia type 1 according to guidelines
- •Unfit for surgery or high-risk surgical patients
- •Endoscopic ultrasound not feasible for surgical altered anatomy
- •Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma
- •Use of anticoagulants that cannot be discontinued
- •International normalized ratio >1.5 or platelet count <50.000
- •Pregnancy or breast feeding
- •Failure to sign the patient's or closest relative's informed consent
研究组 & 干预措施
Endoscopic ultrasound-guided radiofrequency ablation
Endoscopic ultrasound-guided radiofrequency ablation will be performed using the "EUSRA" system (Taewoong, Seoul, Korea). The system consists of a 19-gauge needle electrode (140-cm long), a radiofrequency current generator (VIVA RF generator; Taewoong), and an inner cooling system that circulates chilled saline solution during the radiofrequency ablation procedure. The inner metal part is insulated over its entire length, with the exception of the terminal 5 to 20mm for energy delivery. The needle electrode is attached to the radiofrequency current generator and to a cooling pump. The generator, in addition to providing radiofrequency current, allows the control of physical power and impedance parameters.
干预措施: Endoscopic ultrasound-guided radio frequency ablation (Procedure)
Surgery
Surgical resection will be performed in an inpatient setting. The type and extension of surgical resection, as well as need for lymphadenectomy, will be decided by the treating surgeons according to the tumor position, distance from the main pancreatic duct, and local expertise.
干预措施: Surgery (Procedure)
结局指标
主要结局
Rate of adverse events
时间窗: Up to 72 months
Rate of overall and severe adverse events will be recorded
次要结局
- Recurrence(Up to 72 months)
- Pancreatic insufficiency(Up to 72 months)
- Clinical effectiveness(Up to 72 months)
- Length of hospital stay(Up to 72 months)
- Evaluation of quality of life by questionnaire(Up to 72 months)
- Reintervention(Up to 72 months)
研究者
Stefano Francesco Crinò, MD
Doctor
Azienda Ospedaliera Universitaria Integrata Verona