NCT01144507: PUSH

Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis

Completed Last updated 11 April 2025

What this trial tests

trial testing Abdominal Ultrasound in Cystic Fibrosis in 774 participants. Completed in 14 June 2023.

Timeline

12 January 2010

Primary endpoint
26 February 2021

14 June 2023

Quick facts

Lead sponsor	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	774
Start date	12 January 2010
Primary completion	26 February 2021
Estimated completion	14 June 2023
Sites	11 locations across Canada, United States

Drugs / interventions tested

• Abdominal Ultrasound
• Sample collection procedures

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →
• Pancreatic Insufficiency — all drugs for Pancreatic Insufficiency →

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who can join

Adults 3 to 12, any sex, with Cystic Fibrosis or Pancreatic Insufficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The specific aims for this study are:

1. To determine if sonographic findings predict the risk of progression of liver disease to cirrhosis by comparing cystic fibrosis subjects with heterogeneous echogenicity pattern on ultrasound to those with normal echogenicity pattern on ultrasound
2. To develop a database and biorepository of serum, plasma, urine and DNA to aid the investigations in ascertaining the mechanisms, consequences, genetic risk factors and biomarkers for the development of cirrhosis
3. To determine if there are differences in health related quality of life, pulmonary or nutritional status in children with cystic fibrosis who have a heterogeneous echo pattern on ultrasound compared to those who have a normal echo pattern on ultrasound
4. To determine if Doppler velocity measurements of hepatic and splenic vessels predict an increased risk for the development of cirrhosis.
5. To determine if cirrhosis on ultrasound progresses to portal hypertension during the study period
6. To determine if homogeneous liver progresses to either cirrhosis or heterogeneous liver.
7. To determine the frequency of complications of portal hypertension during follow up in those identified with cirrhosis by year 6 of the study

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Baseline Ultrasound and Clinical Correlates in Children with Cystic Fibrosis.
   Leung DH, Ye W, Molleston JP, Weymann A, et al · · 2015 · cited 29× · PMID 26254836 · DOI 10.1016/j.jpeds.2015.06.062
2. Unmet needs in cystic fibrosis: the next steps in improving outcomes.
   West NE, Flume PA. · · 2018 · cited 13× · PMID 29855230 · DOI 10.1080/17476348.2018.1483723
3. Association Between Transient Elastography and Controlled Attenuated Parameter and Liver Ultrasound in Children With Cystic Fibrosis.
   Ye W, Leung DH, Molleston JP, Ling SC, et al · · 2021 · cited 12× · PMID 34430781 · DOI 10.1002/hep4.1719
4. Poster Session Abstracts.
   · 2016 · cited 7× · PMID 27653516 · DOI 10.1002/ppul.23576
5. Health-related Quality of Life in a Prospective Study of Ultrasound to Detect Cystic Fibrosis-related Liver Disease in Children.
   Schwarzenberg SJ, Palermo JJ, Ye W, Huang S, et al · · 2022 · cited 2× · PMID 36070552 · DOI 10.1097/mpg.0000000000003605