Randomized Trial Comparing Fully Covered, Self-Expanding Metal Stent and Plastic Stents for Endoscopic Ultrasound-guided Drainage of Walled-off Necrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AdventHealth
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- The number of interventions performed between metal and plastic stent groups to achieve treatment success
研究概览
简要总结
The research design is a randomized prospective clinical trial comparing Endoscopic ultrasound (EUS) guided drainage of WON using FCSEMS and plastic stents. The trial will be conducted at the Florida Hospital Center for Interventional Endoscopy, Orlando, Florida.
详细描述
The research design is a randomized prospective clinical trial comparing EUS-guided drainage of WON using FCSEMS and plastic stents. The trial will be conducted at the Florida Hospital Center for Interventional Endoscopy, Orlando, Florida.The sample size estimated for this study is 60 patients. All patients will undergo EUS-guided drainage of WON and be randomized to either FCSEM or plastic stents in a 1:1 ratio using a computer-generated randomized sequence. It will not be possible to blind the endoscopist to the stent type being inserted due to the differences in stent appearance. The statistician will be blinded to the stent type utilized.
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
- Single (Outcomes Assessor)
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
- •The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements.
- •The subject (or when applicable the subject's LAR) is able to understand and willing to sign an informed consent form prior to the initiation of any study procedures.
- •Males or females ≥ 18 years of age.
- •WON diagnosed on contrast-enhanced dual phase CT abdomen/pelvis (CECT) or MRI with gadolinium (seen as a fluid collection in the setting of documented pancreatic necrosis that contains necrotic material and encased within a well-defined tissue layer).
- •WON of any size with any quantity of solid/necrotic component and any no. of loculations, located within the pancreatic/peri-pancreatic space not requiring percutaneous drainage, within 2cm of the enteric wall
- •Suspected/confirmed infected WON (defined as temp ≥ 100.5°F, serum White Blood Cells ≥ 15x109/L, positive blood cultures or positive Gram stain/culture of aspirated necrotic material), and/or symptomatic WON (defined as abdominal pain, gastric/intestinal/biliary outlet obstruction resulting in nausea, vomiting, early satiety, jaundice, or persistent malaise) ≥ 4 weeks from attack of acute pancreatitis.
- •Documented history of acute or chronic pancreatitis:
- •i. Acute pancreatitis is diagnosed if 2 of the following 3 criteria are met:
- •Abdominal pain characteristic of acute pancreatitis
- •Serum lipase/amylase ≥ x3 upper limit of normal
- •Characteristic radiological findings of acute pancreatitis on CECT/MRI/US abdomen, such as homogeneous enhancement of pancreatic parenchyma, standing of peripancreatic fat ii. Chronic pancreatitis is diagnosed if characteristic radiological changes are seen on CT/MRI with Magnetic resonance cholangiopancreatography (MRCP) (such as pancreatic atrophy, dilated pancreatic duct, pancreatic calcification) or EUS (≥5/9 of Rosement criteria)
- •Able to undergo general anesthesia
排除标准
- •Females who are pregnant or lactating. Pregnancy for females of childbearing potential will be determined by routine preoperative urine or serum Human Chorionic Gonadotropin testing.
- •Irreversible coagulopathy (INR >1.5, thrombocytopenia with platelet count <50,000/mL)
- •Has surgically altered gastrointestinal anatomy such as but not limited to Billroth II, Roux-en-Y, gastric bypass
- •Age < 18 years
- •Unable to obtain consent for the procedure from either the patient or LAR
- •Use of anticoagulants that cannot be discontinued for the procedure
- •Unable to tolerate general anesthesia
- •WON that is not accessible for EUS-guided drainage
- •Percutaneous drainage of WON is required or performed prior to EUS-guided drainage
结局指标
主要结局
The number of interventions performed between metal and plastic stent groups to achieve treatment success
时间窗: 6 weeks
The primary objective of this study is to compare the number of interventions performed between metal and plastic stent groups to achieve treatment success at 6 week follow-up. Re-intervention is defined as the need for repeat EUS-guided drainage of WON using the same stent type and/or DEN and/or insertion of percutaneous catheter due to inadequate treatment response following initial WON drainage. As FCSEMS have larger diameter than plastic stents, the investigators hypothesize that the no. of re-interventions performed will be lower in the FCSEMS group compared to the plastic stent group.
次要结局
- Technical success(at index treatment Day 0)
- Cost Analysis (Inpatient and outpatient costs)(6 months)
- Duration of hospitalization(6 months)
- Treatment success(6 week)
- Treatment failure(6 months)
- Recurrence(6 months)
- Adverse events(6 months)
- Procedure duration (minutes)(at index treatment Day 0)