Comparison Outcomes and Complications of Self-Propelled vs. Standard Percutaneous Endoscopic Gastrojejunostomy (PEG-J); a Randomized Single Blind Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Number of Participants With PEG-J Tube Migration
研究概览
简要总结
Our main hypothesis is that self-propelled Percutaneous Endoscopic Gastrojejunostomy tube (PEG-J) that has a balloon on it's tip is associated with lower J-tube retrograde migration rate, and lower rates of short- and long-term complications when compared to standard PEGJ feeding tubes.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive adult patients (18-80 years of age) with need for post-pyloric feeding (patients unable to eat due to stroke, intubated patients with respiratory failure, patients with acute pancreatitis, etc).
- •Ability to give informed consent.
排除标准
- •Unable to give informed consent
- •Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing)
- •Acute gastrointestinal bleeding
- •Coagulopathy defined by prothrombin time < 50% of control; PTT > 50 sec, or INR > 1.5), on chronic anticoagulation, or platelet count <50,000
- •Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy
- •Cirrhosis with portal hypertension, varices, and/or ascites
- •Allergy to egg
研究组 & 干预措施
Self-propelled PEGJ feeding tube
Patients in this arm will receive self-propelled balloon PEGJ tube.
干预措施: PEG-J placement (Device)
Standard PEGJ feeding tube
Patients in this arm will receive the standard commercially availabel PEGJ tube.
干预措施: PEG-J placement (Device)
结局指标
主要结局
Number of Participants With PEG-J Tube Migration
时间窗: From date of placement up to 4 weeks
Number of participants in whom migration was assessed by X-ray at 4 weeks post-intervention.
次要结局
- Patency of Feeding Tube(2 years)
- Technical Success(Intra-procedural)
- Intervention Time(Intra-procedural)
- Time to Repeat Endoscopy for Tube Replacement(2 years)
- Long-term Complications(2 years)
- Repeat Endoscopy for Feeding Tube Placement Due to Retrograde Tube Migration(4 weeks)
- Difficulty of the Procedure(Inra-procedural)
- Gastrointestinal Quality of Life Index (GIQLI) Score(3 month)
- Short-term Complications(One week)
- Direct Cost(2 years)
研究者
Mouen Khashab
Assistant Professor of Medicine; Director of Therapeutic Endoscopy
Johns Hopkins University