Randomized Trial Comparing Immediate Endoscopic Necrosectomy vs. Step-up Endoscopic Interventions in Necrotizing Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Total number of reinterventions required for treatment success
研究概览
简要总结
This is a randomized trial comparing immediate endoscopic necrosectomy vs. step-up endoscopic interventions in patients with necrotizing pancreatitis.
详细描述
In patients with necrotizing pancreatitis, there has been a recent shift away from surgical debridement (surgical necrosectomy) towards minimally invasive endoscopic treatment. Endoscopic management involves the creation of a fistula (tract) between the gastric or duodenal wall and the necrotic collection, under the guidance of endoscopic ultrasound (EUS) with subsequent placement of a stent. In addition, performing endoscopic necrosectomy, which involves extraction of necrotic material under direct endoscopic visualization has increased rates of treatment success to greater than 80%.
However to date, there are currently scant data on the optimal timing of endoscopic necrosectomy. The aim of this randomized trial is therefore to compare the clinical outcomes between patients undergoing immediate endoscopic necrosectomy compared to step-up endoscopic interventions in patients undergoing endoscopic therapy for necrotizing pancreatitis.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patient undergoing procedure and research coordinator assessing outcome measures during follow-up will be blinded to the treatment group to which the patients are randomized.
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 or over
- •Symptomatic necrotic collection (that is suspected or confirmed to be infected), diagnosed on MRI or CT abdomen/pelvis (seen as a fluid collection in the setting of documented pancreatic necrosis that contains necrotic material and encased within a partial or complete wall)
- •Necrotic collection of any size with extent to necrosis of ≥ 33% and any number of loculations, located within the pancreatic/peri-pancreatic space
- •Necrotic collection visualized on EUS and amenable to EUS-guided drainage
排除标准
- •Age < 18 years
- •Females who are pregnant
- •Necrotic collection that is not amenable for EUS-guided drainage
- •Irreversible coagulopathy (defined as INR >1.5, thrombocytopenia with platelet count < 50,000/mL)
- •Use of anticoagulants that cannot be discontinued for the procedure
- •Unable to obtain consent for the procedure from either the patient or LAR
结局指标
主要结局
Total number of reinterventions required for treatment success
时间窗: 6 months
Treatment success is defined as the resolution of necrotic collection on CT scan in association with clinical resolution of symptoms at 6-month follow-up (6 months from index intervention)
次要结局
- Rate of treatment success(6 months)
- Total number of readmissions due to disease-related symptoms or procedure-related events(6 months)
- Rate of technical success for EUS-guided cystogastrostomy(24 hours)
- Rate of technical success for endoscopic necrosectomy(24 hours)
- Rate of exocrine pancreatic insufficiency(6 months)
- Rate of new onset diabetes(6 months)
- Post-procedure length of intensive care unit (ICU) stay(6 months)
- Total length of hospital stay(6 months)
- Overall treatment costs measured in US dollars(6 months)
- Rate of resolution of pre-intervention systemic inflammatory response syndrome (SIRS)(72 hours)
- Rate of resolution of at least 1 pre-intervention organ failure at 72 hours post index intervention(72 hours)
- Rate of procedure-related adverse events(6 months)
- Rate of disease-related adverse events(6 months)