EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent for the Management of Pancreato-biliary Diseases: a Multi-national, Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Clinical success for pancreatic fluid collections
研究概览
简要总结
To evaluate clinical efficacy and safety of a novel lumen-apposing FCSEMS for EUS-guided transenteric drainage of PFC or of biliary tree including GB
详细描述
Patients with the following conditions would be recruited for drainage under EUS guidance with the new lumen apposing FCSEMS
- Symptomatic or infected pancreatic pseudocyst or walled-off necrosis (WON) (SPAXUS 16 or 10 mm)
- Acute cholecystitis by inoperable malignant diseases (SPAXUS 10 mm)
- Acute cholecystitis by benign conditions with high-risk for operation (SPAXUS 10 mm)
- Long-term cholecystostomy at high-risk for operation (SPAXUS 10 mm)
- Symptomatic malignant obstruction of the distal CBD with unsuccessful transpapillary approach (the diameter of the CBD > 10 mm) (SPAXUS 8 or 10 mm)
Outcome paramaters include technical and clinical success, adverse events.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must meet all of the following inclusion criteria to be eligible for enrollment into the study.
- •Pancreatobiliary diseases that are eligible for EUS-guided transenteric drainage
- •The patient who aged from 20 to 80 years. Legally acceptable representative must be capable of giving written informed consent prior to participation in this study
- •Target lesion that is accessible through the transenteric approach
- •The woman of child-bearing age must be negative from the pregnancy test in order to participate in this study
- •The patient who is willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures
- •The patients should not have any unacceptable conditions (e.g., physiological, familyism, social, geographical) for medical follow-up and adaptation of the study.
排除标准
- •Patient presenting with any of the following will not be included in the study.
- •Inaccessible to EUS-guided approach
- •Bleeding tendency: International normalized ratio (INR) of prothrombin time < 1.5 or platelet conunt < 60,000/mm3
- •Patients with Disseminated Intravascular Coagulation syndrome(DIC)
- •Patients who have been taking medicines that can cause hemorrhage (e.g., Aspirin, Wafarin etc.)
- •Patients with other serious disease or medical condition
- •Patients with past medical history of significant neurologic or Psychiatric disorders such as dementia or seizure
- •Unstable heart disease despite of treatment, recent myocardial infarction within 6 month (Even though MI was diagnosed within 6 months, if it becomes stable presently, the patient can be possible to participate).
结局指标
主要结局
Clinical success for pancreatic fluid collections
时间窗: 8 hrs
① Clinical success of pancreatic fluid collections * Peudocyst: resolution more than 50% in the initial size of cyst. * Walled-off necrosis: resolution of PFC without the need for additional interventions after endoscopic interventions.
Clinical success for obstructive jaundice
时间窗: 2 weeks
- A decrease in total bilirubin to \< 50 % of the pre-stenting value within 2 weeks.
Clinical success for acute cholecystitis
时间窗: 8hrs
- Afebrile for 8 hours, tolerating diet, absence of abdominal sign, or 20% decrease in white cell count.
次要结局
- Techincal success(1 day)
- Adverse events(30 day)
研究者
Anthony Teoh
Associate Professor
Chinese University of Hong Kong