A Randomized Control Trial of Plastic Stents vs. NAGI Bi-flanged Metal Stent for Endoscopic Ultrasound Guided Drainage of Walled-off Necrosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- Number of patient achieving Clinical Success
研究概览
简要总结
Introduction:
Walled off necrosis (WON) is defined as a well circumscribed pancreatic and/or peri pancreatic necrosis containing a variable amount of necrotic tissue. WON usually occurs >4 weeks after onset of necrotizing pancreatitis. It is associated with significant morbidity and mortality especially if infected. Symptomatic WON should be drained either percutaneously, endoscopically or surgically. Minimal invasive approaches are being increasingly used for effective management of WON as it is associated with less adverse events. Various recent studies have shown that endoscopic approach have improved clinical outcome, less hospital stay and lower cost compared to surgical approach.
Endoscopic ultrasound guided drainage of WON with either plastic stents or lumen apposing metal stents (LAMS) is mainstay of WON management. A systemic review based on retrospective comparative studies showed no difference regarding treatment success for WON by plastic or metal stents6. However, metal stent had shorter procedure time. A Single center RCT from USA comparing LAMS vs multiple plastic stents for WON has shown that except shorter procedure duration, there was no significant difference in treatment outcomes. To minimize LAMS related adverse events, it should be removed within 3 weeks. However, in the same study 25.8% patients of LAMS group and 55.2% patients of plastic stent group underwent additional intervention within 72 hours for persistent symptoms.
Larger diameter, specific stent designs to reduce adverse events should have better outcome with LAMS as compared to plastic stents. Primary outcome of this single center randomized controlled trial is to examine whether dedicated NAGI bi-flanged metal stents (BFMS) are superior to plastic stent in terms of short term and long term success.
Aims and Hypothesis:
The aim of the current study is to study whether NAGI BFMS are superior to plastic stent in terms of short term and long term success in the EUS guided drainage of WON.
The investigators hypothesize that the clinical success with NAGI BFMS would be better than plastic stents in the EUS guided drainage of WON.
详细描述
1.1 Patient recruitment Patients would be recruited from the in-patient or outpatient department prior to their scheduled endoscopic intervention.
1.2 Study design This is a single center randomized controlled study with two parallel groups without masking with a 1:1 allocation ratio
1.3. Study intervention - stent placement The procedures would be performed by experienced endoscopists. All procedures will be performed with the patient in the left lateral position under propofol sedation after administration of intravenous antibiotics (third generation cephalosporins) A therapeutic linear echo-endoscope (UCT-180; Olympus Ltd, Tokyo, Japan) will be used; the PFC assessed for size, wall maturity, thickness, interposing collaterals and percentage of solid debris.
NAGI BFMS - The WON will be punctured using a standard 19-gauge FNA needle and the aspirate was sent for biochemical and microbial analysis. A 0.025-inch (Visiglide; Olympus Corporation, Tokyo, Japan) or 0.035-inch stiff guidewire (Jag Wire; Boston Scientific) passed through the needle into the cyst cavity to form at least 1 to 2 loops under fluoroscopic guidance. A 6F cystotome (Endo-flex GmbH Dusseldorf, Germany) will be passed over the guidewire for creating a fistula. Subsequently, a 6-mm balloon dilator (Hurricane; Boston Scientific Corporation or Titan balloon, Wilson Cook) will be used to further dilate the fistula tract. After this, the stent delivery catheter is advanced over the guidewire across the PFC wall and the BFMS (Nagi; Taewoong Medical, Gyeonggi-do, South Korea) deployed using sonographic, fluoroscopic and endoscopic visualization.
Plastic stents - Double-pigtail plastic stents will be used. A minimum of one 10Fr pigtail plastic stent will be placed. After initial EUS-guided access, the ostomy will be dilated first, using a cystotome, and secondly with a balloon dilation. The plastic stent will be inserted and delivered following the routine technique of each interventional endoscopist. The number of the plastic stents and the size of the balloon used to dilate the ostomy will depend on the WON size and content.
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
- •Adult >18 years,
- •Patient with symptomatic WON
- •Debris <50% (based on cross sectional imaging)
- •Written informed consent
排除标准
- •Pregnancy or breast feeding,
- •Severe coagulopathy INR >1.5 which is not correctable and/or platelets <50000/mm3
- •Endoscopic drainage is technically not feasible
- •Fluid collections other than WON
- •Patient who is unable to understand study protocol or not willing for follow-up requirements
结局指标
主要结局
Number of patient achieving Clinical Success
时间窗: 4 weeks
Clinical success at 4 weeks determined by the reduction of the collection (\<50% or \<5 cm in size) along with resolution of symptoms.
次要结局
- Number of patients developing Adverse events(24 weeks)
- Number of patients achieving Long term success(24 weeks)
- Re-Interventions(4 weeks)