Feeding Tubes for Pneumonia Prevention

Overseen by Jerry Dang, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Jerry Dang

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

Jerry Dang, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

This trial is for adults needing a new long-term feeding tube but don't have pneumonia, COVID-19, an existing feeding tube, past stomach surgery, gastroparesis, digestive blockages, aren't pregnant or incarcerated. They must understand English.

Inclusion Criteria

I need a feeding tube as advised by my doctor.

I am 18 years old or older.

Exclusion Criteria

I do not have pneumonia right now.

Pregnancy

I cannot have an upper endoscopy due to health reasons.

Treatment Details

Interventions

• PEG (Procedure)
• PEG-J (Procedure)

Trial Overview The study compares two types of feeding tubes: the standard PEG that goes into the stomach and PEG-J which extends into the small intestine. It aims to see if PEG-J reduces pneumonia cases within 30 days without increasing follow-up procedures.

Participant Groups

Group I: PEG arm: Patients receiving the 20-French pull-type PEG tube Active Control 1 Intervention

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.

Group II: PEG-J arm: Patients receiving the 24-French pull-type PEG with 12-French jejunal extension tube Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Jerry Dang

Lead Sponsor

Trials

1

Recruited

160+