Percutaneous Endoscopic Gastrostomy Versus Percutaneous Endoscopic Gastrostomy With Jejunal Extension: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of Participants Who Developed Post-Procedure Pneumonia
研究概览
简要总结
The goal of this clinical trial is to learn if placing a feeding tube with a small bowel extension (called Percutaneous Endoscopic Gastrostomy With Jejunal Extension [PEG-J]) is better at preventing pneumonia than a standard feeding tube (called Percutaneous Endoscopic Gastrostomy [PEG]) in people who need long-term tube feeding. Researchers want to know if people who receive a PEG-J have fewer cases of pneumonia in the first 30 days compared to those who receive a standard PEG, and whether PEG-J tubes require more follow-up procedures to fix tube problems.
Researchers will compare two different types of feeding tubes: a standard feeding tube that goes into the stomach (PEG) versus a feeding tube that extends past the stomach into the small intestine (PEG-J). This will help determine which type of feeding tube is safer and works better for patients.
Participants will be randomly assigned to receive either a PEG or PEG-J feeding tube through a minimally invasive procedure. They will start receiving nutrition through the tube 24 hours after placement and be monitored for 30 days to check for problems like pneumonia or tube malfunction, while receiving regular medical care from their treating doctors.
The study is open to people who are 18 years or older and need a new feeding tube for long-term nutrition. People cannot take part if they have pneumonia, COVID-19, an existing feeding tube, previous stomach surgery, gastroparesis (a condition affecting stomach movement), digestive system blockage, are pregnant, or are in prison. All participants must understand English.
Participation is voluntary, and participants can leave the study at any time. The study team will carefully monitor all participants for any problems throughout the 30-day period
详细描述
This randomized clinical trial investigates the comparative efficacy of percutaneous endoscopic gastrostomy (PEG) versus percutaneous endoscopic gastrostomy with jejunal extension (PEGJ) for long-term enteral access. The study addresses a critical knowledge gap in the literature regarding the optimal approach for enteral feeding in patients at risk for aspiration.
Current evidence suggests that aspiration pneumonia occurs in up to 30% of patients following PEG placement, with some studies demonstrating aspiration in up to 38% of patients immediately after enteral feeding administration. This high rate is hypothesized to result from gastric reflux. While PEGJ has been proposed as a potential solution by advancing feeds beyond the pylorus, existing evidence consists primarily of small case series and retrospective studies, with reported aspiration pneumonia rates of approximately 10%. However, the methodological limitations of these studies and contradicting findings create uncertainty about the optimal approach.
A recent meta-analysis of enteral feeding in critically ill patients suggested potential benefits of post-pyloric feeding, but included moderate to low quality evidence and did not directly compare PEG versus PEGJ. Furthermore, some researchers argue that aspiration events may result from oropharyngeal dysphagia rather than gastric reflux, potentially limiting the benefit of jejunal extension.
The study employs a prospective, randomized design with 1:1 allocation using distance randomization via RedCap to ensure allocation concealment. Sample size calculation was based on detecting a 20% difference between groups in aspiration pneumonia rates, with power analysis accounting for a statistical power of 0.8 using chi-square test methodology.
The technical aspects of tube placement follow standardized protocols. For PEG placement, a 20-French pull-type tube is positioned using safe track technique with transillumination and 1:1 finger indentation, placing the tube midway between the greater and lesser curves of the stomach. The PEGJ procedure begins similarly but utilizes a 24-French pull-type PEG followed by advancement of a 12-French jejunal extension tube, which is secured to the small bowel wall with endoclips as indicated.
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
- 是
入选标准
- •Age 18 years or older
- •Requires feeding access as determined by treating provider
排除标准
- •Concurrent pneumonia at time of enrollment
- •Concurrent COVID-19 diagnosis
- •Prior feeding access (transabdominal feeding access)
- •Prior upper gastrointestinal surgery (previous gastric resection surgery)
- •Gastroparesis
- •Obstruction or pseudo-obstruction
- •Pregnancy
- •Contraindication to undergo upper endoscopy
- •Prisoners
- •Primary language is not English
研究组 & 干预措施
PEG arm: Patients receiving the 20-French pull-type PEG tube
PEG Arm:
Participants receive a 20-French pull-type percutaneous endoscopic gastrostomy tube placed into the stomach using standard safe track technique with transillumination and 1:1 finger indentation. The tube is positioned midway between the greater and lesser curves of the stomach. Continuous tube feeds begin 24 hours after placement. Follow-up period is 30 days.
干预措施: (Arm 1): PEG (Procedure)
PEG-J arm: Patients receiving the 24-French pull-type PEG with 12-French jejunal extension tube
Participants receive a 24-French pull-type percutaneous endoscopic gastrostomy tube with a 12-French jejunal extension. After standard PEG placement, the jejunal extension tube is advanced past the pylorus and secured to the small bowel wall with endoclips as indicated. Continuous tube feeds begin 24 hours after placement. Follow-up period is 30 days.
干预措施: (Arm 2): PEG-J (Procedure)
结局指标
主要结局
Number of Participants Who Developed Post-Procedure Pneumonia
时间窗: From day of procedure (day 0) through 30 days post-procedure
Diagnosis of pneumonia will be determined based on clinical judgment of the treating provider and must be explicitly documented as "pneumonia" in the medical record.
次要结局
- Number of Participants Requiring Additional Procedures Due to Tube Malfunction(From day of procedure (day 0) through 30 days post-procedure)
- Number of Participants with Post-Operative Complications(From day of procedure (day 0) through 30 days post-procedure)
- Total Procedure Time in Minutes from Start to Completion of Feeding Tube Placement(Day of procedure)
研究者
Jerry Dang
Associate Professor of Surgery
The Cleveland Clinic