Nasojejunal Feeding Versus Oral Feeding Following Endoscopic Drainage of Walled Off Pancreatic Necrosis: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Nutritional failure
研究概览
简要总结
The goal of this randomized control trial is to assess whether nasojejunal feed is better than oral nutrition in patients who are undergoing endoscopic cystogastrostomy of walled off necrosis following acute pancreatitis. It will also try to answer, the incidence of infections and feed tolerance.
The main question it tries to answer is
- whether nasojejunl feed is better than oral feed in patients undergoing endoscopic cystogastrostomy in walled off necrosis following acute pancreatitis
- How much infections they develop, whether they are able to tolerate the feed, weight gain and reintervention rates in each group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of acute pancreatitis (AP) with 18-75 years of age
- •Patients with symptomatic WON requiring EUS guided transluminal drainage
- •Provision of written informed consent
排除标准
- •Patients with collection not amenable for EUS guided drainage (distance of WON >1 cm from the gastrointestinal lumen)
- •Known malignancy or immunocompromised state
- •Previous upper gastrointestinal(GI) surgery interfering with absorption
- •Active GI bleeding
- •GI obstruction, ileus or persistent vomiting
- •Patients moribund to undergo endoscopic procedure (Glasgow coma scale <8 or patients on ventilatory support)
- •Patients with irreversible coagulopathy like platelets <50,000/mm3 and/or INR>1.5
- •Pregnant or lactating female
研究组 & 干预措施
Nasojejunal feeding arm
干预措施: endoscopic ultrasonography guided cystogastrostomy (Procedure)
Oral feeding
干预措施: endoscopic ultrasonography guided cystogastrostomy (Procedure)
结局指标
主要结局
Nutritional failure
时间窗: 14 days
To compare the rate of nutritional failure at Day 14 between Nasojejunal and oral feeding post endoscopic transmural drainage of WON
次要结局
- Infection and new onset organ failure(14 days)
- Re-intervention needs(14 days)
- Change in weight(14 days)
- Inflammatory markers(14 days)
研究者
Saurabh Kumar Singh
Senior Resident, Department of Gastroenterology
Post Graduate Institute of Medical Education and Research, Chandigarh