COMPARISON OF OUTCOMES OF BI-FLANGED METAL STENT ALONE VERSUS BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WALLED-OFF PANCREATIC NECROSIS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Adverse evens rates associated with both the groups ( stent clogging and stent migration, bleeding).
研究概览
简要总结
Endoscopic ultrasound guided drainage of WON with metal stent is the mainstay of WON management.
But there are few complications related to BFMS , like bleeding due to vessel erosion, stent clogging , stent migration .
This study is to assess, whether placing an anchoring DPS through the BFMS will decrease adverse events or not.
There are only 2 retrospective studies till date ,comparing LAMS with coaxial stent vs LAMS alone.
one study showed no significant decrease in adverse events , one study showed decrease in adverse events when DPS with LAMS .
But there has been no prospective RCT to assess the utility of DPS to date
详细描述
Inclusion Criteria: -
- Symptomatic Walled-off pancreatic necrosis (WON)
- Eligible for EUS guided BFMS placement
- Signed informed consent .
- Age >18 Years
Exclusion Criteria: -
- Types of pancreatic collections other than WON .
- Drainage with stents other than BFMS
- Previous attempts at drainage of WON
- Coagulopathy (INR>1.5) or thrombocytopenia(plc <50000/cmm)- not correctable.
- Pregnancy
- Not willing to give informed consent
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic Walled-off pancreatic necrosis (WON)
- •Eligible for EUS guided BFMS placement
- •Signed informed consent .
- •Age >18 Years
排除标准
- •Types of pancreatic collections other than WON .
- •Drainage with stents other than BFMS
- •Previous attempts at drainage of WON
- •Coagulopathy (INR>1.5) or thrombocytopenia(plc <50000/cmm)- not correctable.
- •Not willing to give informed consent
研究组 & 干预措施
NAGI BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WOPN.
Endoscopic ultrasound guided drainage -Nagi Bi Flanged metal stent--16mm diameter 2cm long with co Axial double pig tail stent used for drainage of walled of necrosis. Intra and post prodecural complications will be noted, a plane CT screening abdomen will be performed with in 48 to 72 hours to document the size of collection.
干预措施: Endoscopic ultrasound guided drainage of walled off pancreatic necrosis (Procedure)
NAGI BI-FLANGED METAL STENT ALONE FOR DRAINAGE OF WOPN.
Endoscopic ultrasound guided drainage -Nagi Bi Flanged metal stent--16mm diameter 2cm long used for drainage of walled of necrosis. Intra and post prodecural complications will be noted, a plane CT screening abdomen will be performed with in 48 to 72 hours to document the size of collection.
干预措施: Endoscopic ultrasound guided drainage of walled off pancreatic necrosis (Procedure)
结局指标
主要结局
Adverse evens rates associated with both the groups ( stent clogging and stent migration, bleeding).
时间窗: 4 weeks
To monitor the adverse events like bleeding, stent clogging and stent migration.
次要结局
- re-intervention rates(4 weeks)
- Clinical success rate(4 weeks)
- Technical success rate(4 weeks)
研究者
Mohan Ramchandani
Doctor
Asian Institute of Gastroenterology, India