Ultrasound for Evaluation of Percutaneous G-tube Position

Accuracy of Ultrasound for the Evaluation of Percutaneous Gastrostomy Tube Position and Leakage

The goal of this clinical trial is to compare using ultrasound imaging to look at the position of the gastrostomy tube (GT) against fluoroscopic imaging in pediatric patients who had a recent GT tube replacement.

The main questions it aims to answer are:

• If ultrasound is just as accurate as fluoroscopy to assess the GT position.
• If ultrasound takes less time than fluoroscopy to assessing the GT position.

Participants will be imaging using ultrasound to assess GT positioning before their standard of care fluoroscopic imaging.

Study Overview

• Status: Recruiting
• Conditions: Gastrostomy
• Intervention / Treatment: Device: Ultrasound Imaging

Detailed Description

This clinical trial will address the validity of using ultrasound to evaluate the position of the gastrostomy tube (GT) retention balloon against the clinical gold standard of fluoroscopic tube injection to assess for potential larger studies and the implementation in clinical practice. This study will address the ability to visualize the retention balloon within the gastric lumen, the ability to assess for leakage from the GT within the abdomen, and the relative length of each study to perform.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannah P Mignosa-Martin; Phone Number: 9198431670; Email: hannah_mignosa@med.unc.edu
• Study Contact Backup: Name: Desma Jones; Phone Number: 9198439463; Email: desma_jones@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina at Chapel Hill
      • Contact: Markeela Lipscomb; Phone Number: 919-843-3670; Email: markeela_lipscomb@med.unc.edu
      • Contact: Desma Jones; Phone Number: 9198439463; Email: desma_jones@med.unc.edu
      • Principal Investigator: William Pryor, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

An individual who presents with a dislodged GT and meets one of the following minor criteria:

• Surgical GT placement less than 90 days from presentation
• Traumatic GT dislodgement/removal
• Recent stoma dilation
• Clinician uncertainty about position of GT placement

Exclusion Criteria:

• An individual >18 years of age
• Acutely ill patients defined as hemodynamically unstable defined as any child who has abnormal vital signs or disruption of vital functions (i.e. airway, breathing, circulation, mental function). Vital signs are based on patient age. Initial assessment of clinical patient stability will be provided by the ordering/referring provider.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Ultrasound Imaging; This study consists of one group/ All participants will receive ultrasound imaging prior to the standard of care fluoroscopic imaging.	Device: Ultrasound Imaging; Participant will receive ultrasound imaging to evaluate the replaced G-tube placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Ultrasound that Agree with Fluoroscopy with Respect to Identifying the GT Location	Proportional accuracy of ultrasound in identifying the gastrostomy tube (GT) balloon location based on the readers' (radiologists) ability to use the ultrasound to locate the GT balloon in comparison with the gold standard (fluoroscopic tube injection).	Upon completion of all study image data collection for all participants [approximately 1 year]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of ultrasound (US) to determine the visualization of GT leakage	Sensitivity of ultrasound to determine the visualization of the GT leakage is defined as the ability of readers (radiologists) to use the ultrasound to determine the presence or absence of injected saline leakage under ultrasound using fluoroscopic tube injection as the gold standard.	Upon completion of all study image data collection for all participants [approximately 1 year]
Specificity of ultrasound (US) to determine the visualization of GT leakage	Specificity of ultrasound to determine the visualization of the GT leakage is defined as the ability of readers (radiologists) to use the ultrasound to determine the presence or absence of injected saline leakage under ultrasound using fluoroscopic tube injection as the gold standard.	Upon completion of all study image data collection for all participants [approximately 1 year]
Duration of ultrasound (US) to complete evaluation of GT position	Duration of ultrasound to complete the evaluation of the GT position is defined as the length of time necessary to complete a research US evaluation of the GT position using fluoroscopic tube injection as the gold standard.	Upon completion of all study image data collection for all participants [approximately 1 year]

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: William Pryor, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: ultrasound; fluoroscopy; gastrostomy tube
• Other Study ID Numbers: 23-3115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: 9 to 36 months following publication.
• IPD Sharing Access Criteria: The investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No