Transient Elastography (TE) for evaluation of liver disease in pediatric patients with intestinal failure

K
Kanika Puri, MD

Primary Investigator

Enrolling By Invitation
18 years and younger
All
Phase N/A
30 participants needed
1 Location

Brief description of study

We are investigating the use of a painless ultrasound technology called Transient Elastography (TE) to measure changes in the liver that indicate the amount of scar tissue in the liver. Ultrasound technology works by placing a probe on the outside of your body, which uses sound waves to create a picture of the inside your body. We will analyze these results along with other medical information about you. Our hope is to use these measurements of changes in the liver, lab tests, and other medical information to better understand why some patients with intestinal failure or short gut syndrome develop liver problems.

Detailed description of study

Participants in this study will have the measurement done at a regular clinic visit. Participants will undergo an ultrasound exam utilizing the TE machine.  Trained staff will apply a water-based gel to the right chest wall and move a small probe over the area to look at the liver. After the exam, the gel will be removed with a soft cloth. The exam will take between 15 and 30 minutes. Researchers will look at things like medical records, lab results and other changes with how the intestines are working and repeat the ultrasound exam with the TE machine at follow up year 1 and 2.  Participants can request the results of the examination. This technology has mainly been used in adults and we want to better understand how it works for kids. Researchers will review medical records to obtain information about medical diagnoses and results of laboratory tests.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: intestinal failure, Riley
  • Age: - 18 Years
  • Gender: All

Inclusion Criteria:
  • Children under the ages of 18 years with intestinal failure
Exclusion Criteria:
  • Presence of significant ascites
  • Open wound near sensor application site 
  • Pregnancy
  • Unable or unwilling to give informed consent or assent
  • Patient unable or unwilling to tolerate the TE measurement procedure
  • Unable or unwilling to sign consent

Updated on 13 Sep 2024. Study ID: 11197, PGI-IIR-TE
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