TERMINATED

Percutaneous Endoscopic Gastrostomy Versus Percutaneous Endoscopic Gastrostomy With Jejunal Extension

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Percutaneous Endoscopic Gastrostomy Versus Percutaneous Endoscopic Gastrostomy With Jejunal Extension: A Randomized Clinical Trial

Quick Facts

Study Start:2025-02-27
Study Completion:2025-06-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT06717321

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older
  2. * Requires feeding access as determined by treating provider
  1. * Concurrent pneumonia at time of enrollment
  2. * Concurrent COVID-19 diagnosis
  3. * Prior feeding access (transabdominal feeding access)
  4. * Prior upper gastrointestinal surgery (previous gastric resection surgery)
  5. * Gastroparesis
  6. * Obstruction or pseudo-obstruction
  7. * Pregnancy
  8. * Contraindication to undergo upper endoscopy
  9. * Prisoners
  10. * Primary language is not English

Contacts and Locations

Principal Investigator

Jerry Dang, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Jerry Dang

  • Jerry Dang, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-27
Study Completion Date2025-06-10

Study Record Updates

Study Start Date2025-02-27
Study Completion Date2025-06-10

Terms related to this study

Keywords Provided by Researchers

  • tube feeds
  • aspiration pneumonia
  • peg
  • peg-J
  • enteral feeding

Additional Relevant MeSH Terms

  • Aspiration Pneumonias
  • Tube Feeding
  • Enteral Feeds