Percutaneous Endoscopic Gastrostomy Versus Percutaneous Endoscopic Gastrostomy With Jejunal Extension

August 1, 2025 updated by: Jerry Dang

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Both groups will receive continuous feeding rather than bolus feeding to standardize the feeding methodology. The study design accounts for potential confounding factors by excluding patients with conditions that might independently affect aspiration risk or tube function, such as gastroparesis or prior upper gastrointestinal surgery.

The research addresses both clinical efficacy and practical considerations, as PEGJ tubes have reported malfunction rates of up to 50%, potentially requiring additional interventions. This prospective investigation will provide high-quality evidence to guide clinical decision-making, balancing the potential benefits of aspiration reduction against the risks of tube dysfunction and need for reintervention.

Statistical analysis will be conducted by an internal biostatistician using appropriate methodologies for both continuous and categorical variables, with adjustments for non-normal distributions when necessary. The study's 30-day follow-up period was selected based on typical timeframes for post-procedure complications and tube-related adverse events.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: (Arm 1): PEG
A 20-French pull type percutaneous endoscopic feeding tube placed into the stomach using endoscopic guidance
Active Comparator: 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.
Procedure: (Arm 2): PEG-J
24-French pull type percutaneous endoscopic feeding tube placed into the stomach with a 12-French jejunal extension tube advanced through the PEG and positioned post-pyloric in the small bowel using endoscopic guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Developed Post-Procedure Pneumonia
Time Frame: 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.
From day of procedure (day 0) through 30 days post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Requiring Additional Procedures Due to Tube Malfunction
Time Frame: From day of procedure (day 0) through 30 days post-procedure
A tube malfunction is defined as any issue requiring an additional procedure to maintain tube function.
From day of procedure (day 0) through 30 days post-procedure
Number of Participants with Post-Operative Complications
Time Frame: From day of procedure (day 0) through 30 days post-procedure
Any documented post-operative complication will be counted, including but not limited to bleeding, infection, and injury to organs or structures
From day of procedure (day 0) through 30 days post-procedure
Total Procedure Time in Minutes from Start to Completion of Feeding Tube Placement
Time Frame: Day of procedure
Measurement of total operative time from the start of the endoscopic procedure until completion of feeding tube placement and final endoscopic verification of proper positioning. Time will be measured in minutes.
Day of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jerry Dang

Investigators

  • Principal Investigator: Jerry Dang, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

February 27, 2025

Primary Completion (Actual)

June 10, 2025

Study Completion (Actual)

June 10, 2025

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Actual)

December 5, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

August 1, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-170 (VA Health Services Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Based on the protocol's data collection and privacy sections, individual participant data (IPD) that underlie the results reported in published articles will not be shared. The IRB-approved protocol specifies that data access is restricted to the research team and regulatory instances at Cleveland Clinic. As per protocol's privacy and confidentiality section, data will be safeguarded in REDCap with access limited to authorized study personnel, and data retention is specified for 5 years after study completion. These limitations on data sharing are in place to maintain participant confidentiality and comply with the privacy protections promised during the informed consent process.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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