JPRN-jRCTs061200016已完成1 期
Study of endoscopic ultrasonography-guided ethanol injection therapy for patients with pancreaticneuroendocrine neoplasm
Kato Hironari0 个研究点目标入组 25 人开始时间: 2020年9月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
The usefulness of endoscopic ultrasound-guided ethanol injection therapy for pancreatic neuroendocrine tumors was evaluated in this study.Composite endpoint was defined including efficacy (complete ablation of the tumor) and safety (avoidance of pancreatic leakage and diabetic complications), and was compared with historical data from surgery. The rate of achieving composite endopoint was 76%, and it was significant compared with surgical treatment (P=0.0083).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1. 20 to 75 years old of age
- •2. Patient who have been fully informed consent.
- •3. PNEN of which grade was G1 confirmed pathologically by EUS-FNA specimen(WHO 2017 classification)
- •4. Not less than 15 mm of tumor size and well enhanced tumor at the arterial phase on CE-CT
- •5. non-functionnal PNEN or insulinoma
排除标准
- •1. Allergy for contrast media or ethanol
- •2. Within 2 mm of the distance between tumor and main pancreatic duct on radiographic images
- •3. Suspect of lymph node metastasis or distant metastasis on CE-CT.
- •4. Less than 50% of PT or less than 1.5 of INR
- •5. Less than 50,000/ L of PLT
- •6. Less than 30 mL/min of eGFR
- •7. Administeration of more than 2 antithrombotic agents
- •8. Not less than 2 of performance status
- •9. Being pregnant or possibly pregnant
- •10. Less than 5 years of estimated prognosis
- •11. Patients judged as inappropriate candidate by the chief medical examiner
研究者
相似试验
Unknown
不适用
EUS-guided Ethanol-lipiodol Ablation of Pancreatic Neuroendocrine Tumor: a Prospective StudyEfficacySafetyFeasibilityNCT01902238Asan Medical Center34
Unknown
不适用
EUS-guided Ethanol Ablation of an InsulinomaInsulinomaNCT02121366Guangxi Medical University50
已完成
不适用
Endoscopic Ultrasound-guided RadioFrequency Ablation for the Treatment Pancreatic NeuroEndocrine NeoplasmsNeuroendocrine TumorsNeuroendocrine CarcinomaPancreas NeoplasmNeuroendocrine Tumor Gastrointestinal, Hormone-SecretingNCT03834701Catholic University of the Sacred Heart60
已完成
不适用
Pancreatic Endotherapy for Refractory Chronic PancreatitisPancreatic Duct StonePancreatic Duct StricturePancreatic Duct DilatationNCT04232670Oregon Health and Science University14
招募中
不适用
EUS-CPN With and Without BupivacainePancreatic CancerNCT04951804Centre hospitalier de l'Université de Montréal (CHUM)180