Comparing two types of feeding tubes for preventing pneumonia
Percutaneous Endoscopic Gastrostomy Versus Percutaneous Endoscopic Gastrostomy With Jejunal Extension: A Randomized Clinical Trial
This study tests whether a standard feeding tube or a special feeding tube can help prevent pneumonia in patients who need long-term tube feeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 155 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06717321 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two feeding tube types: a standard percutaneous endoscopic gastrostomy (PEG) and a PEG with jejunal extension (PEG-J) in preventing aspiration pneumonia in patients requiring long-term tube feeding. Participants will be randomly assigned to receive either type of feeding tube through a minimally invasive procedure. The study will assess the incidence of pneumonia within the first 30 days post-procedure and evaluate the need for follow-up interventions for tube-related issues. This research addresses a significant gap in understanding the optimal feeding approach for patients at risk of aspiration.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 years or older who require feeding access as determined by their healthcare provider.
Not a fit: Patients with concurrent pneumonia, COVID-19, or prior feeding access may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved feeding tube options that reduce the risk of pneumonia for patients requiring long-term enteral feeding.
How similar studies have performed: While some studies have suggested benefits of jejunal feeding, this trial is among the first to directly compare PEG and PEG-J in a randomized manner.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Requires feeding access as determined by treating provider Exclusion Criteria: * 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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Jerry Dang, MD — The Cleveland Clinic
- Study coordinator: Melissa V Wills, MD
- Email: willsm@ccf.org
- Phone: 216-513-6321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.