NCT03100578已完成不适用
Randomized Multicenter Study Comparing Plastic Stents and Self-expanding Metallic Stents Used in the Eus-guided Transmural Drainage of Walled-off Pancreatic Necrosis.
Hospital Universitari de Bellvitge16 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2017年6月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 16
- 主要终点
- RADIOLOGICAL SUCCESS
研究概览
简要总结
Randomized multicenter study comparing plastic stents and self-expanding metallic stents in the eus-guided transmural drainage of walled-off pancreatic necrosis.
Spanish centers partners of the spanish society of digestive endoscopy.
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
- •Age greater than or equal to 18 years
- •Patient with indication (ASGE, Jacobson BC, GIE2005;) of pancreatic collection drainage type WALLED-OFF PANCREATIC NECROSIS * as a local complication of previous acute pancreatitis.
- •Patient trained to understand and / or sign informed consent
- •Patient who understands the type of study and will comply with all follow-up of complementary tests during its duration
排除标准
- •Pregnancy or breastfeeding
- •Severe coagulation disorder: INR> 1.5 not correctable with plasma and / or platelet administration <50,000 / mm3
- •Asymptomatic patients, with no clinical indication of drainage, except for those with vascular involvement due to compression (eg stenosis, splenic vessels with collateral circulation, and risk of bleeding)
- •Non-identification of solid content during the Endoscopic Ultrasound of the procedure
- •No informed consent
- •In the case of patients with mental retardation, without the ability to understand the nature and possible consequences of the study, except for the existence of a legal representative
- •Patients unable to maintain posterior follow-up (lack of adherence)
- •Situations that do not allow the practice of a high digestive endoscopy (eg, stenosis)
结局指标
主要结局
RADIOLOGICAL SUCCESS
时间窗: 4 weeks
Radiological success at 4 weeks after the interventional procedure: reduction size of the wopn at least 50%.
次要结局
- CLINICAL SUCCESS(4 month)
- TECHNICAL ASPECTS(1st day)
- INCIDENCE OF TREATMENT-EMERGENT ADVERSE EVENTS [SAFETY AND TOLERABILITY](1st day, 24h, 7 days, 4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month)
- RECURRENCES(4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month)
- COSTS ANALYSIS(12 month)
研究者
Joan B Gornals
Principal Investigator
Hospital Universitari de Bellvitge
研究点 (16)
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