EUS Guided Pseudocyst drainage: Prospective evaluation of short term placement of fully covered self expanding metal stents followed by pancreatic ductal stenting (The BIDS Protocol)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- 1.To determine the safety and efficacy of short duration FCSEMS placement for symptomatic pancreatic fliud collection.
研究概览
简要总结
This was a single-center prospective evaluation. All patients with symptomatic pancreatic fluid collection with a well-defined wall will be included in the study for placement of SEMS into the pancreatic pseudocyst followed by pancreatic ductal stenting via ERCP if MRCP demonstrates pancreatic ductal leak.
The patient will be kept under observation for 72 hours. Oral liquids will be allowed after 4 hours if the patient was asymptomatic. Intravenous antibiotics will be continued for 72 hours. Ultrasound for assessment will be done at 24 hr followed by Gastroscopy after 72 hours for necrosectomy. Cyst cavity will be cleaned of any debris by lavage (100 ml normal saline, 10 ml Hydrogen peroxide 6% and povidone-iodine 10% w/v), necrosectomy and suction if debris is present. Follow-up: Patients will be followed-up at 3 monthly intervals with clinical examination and abdominal ultrasonography for one year. Definitions Technical success will defined as successful stent placement. Functional success will be defined as a residual cyst size of <2 cm on abdominal USG 24 hours after the procedure. The Lexicon criteria7 will be used to grade the adverse events. Recurrence will be defined as symptomatic recurrent fluid collection after complete resolution, in the same location as prior pseudocyst on follow-up abdominal ultrasonography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Willing and able to comply with the study procedures and provide written informed consent to participate in the study Symptomatic pancreatic fluid collection.
排除标准
- •Pancreatic fluid collection > 1 cm away from stomach wall 2)Previous history of ERP and PD stenting.
- •Patients for whom endoscopic techniques are contraindicated 4)Participation in another investigational trial within 180 days 5)Pregnancy.
结局指标
主要结局
1.To determine the safety and efficacy of short duration FCSEMS placement for symptomatic pancreatic fliud collection.
时间窗: 3 month follow up
2.For formation of algorithm for management pancreatic fluid collection.
时间窗: 3 month follow up
次要结局
- To study the technical & clinical success and immediate complications of pancreatic fluid collection drainage by FCSEMS.(3 months)
