Utility of Point Shear-wave Elastography to Assess for Hepatic & Pancreatic Fibrosis in Pediatric CF Patients

NCT03264950 | Unknown

• 1 other identifier: B2017:077
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Diagnosis of hepatic fibrosis is challenging as specific tests for detection of fibrosis in pediatric Cystic Fibrosis associated liver disease (CFALD) have not been developed and existing investigations do not correlate well with presence or severity of disease. Using a Liver biopsy it is difficult to diagnose this condition because of the patchy nature of the disease. Investigators intend to identify hepatic and pancreatic fibrosis in Cystic Fibrosis patients using Elastography and correlate this with their biochemical markers as well as histological findings of patients who have undergone liver biopsy for diagnosis of CFALD.

Conditions

Cystic Fibrosis; Cystic Fibrosis Liver Disease; Pancreatic Insufficiency Due to Cystic Fibrosis of Pancreas

Outcome Measures

Primary Outcomes (1)

• Evaluate the diagnostic properties of Shear wave Elastography

  To evaluate the diagnostic properties of Shear wave Elastography (ElastPQ) in children with CF for detection of liver fibrosis. Investigators will look at the values of shearwave elastography and see how it correlates with the fibrosis values obtained on liver biopsy as well as with AST/platelet ratio index

  6 months

Secondary Outcomes (2)

• To compare findings/fibrosis of Transient Elastography vs ElastPQ

  6 months

• To compare the pancreatic insufficiency/ fecal elastase and transient elastography from pancreas.

  6 months

Study Arms (1)

SIngle Arm

OTHER

All patients undergo Elastography. This is a single arm study

Diagnostic Test: Elastography

Interventions

Elastography DIAGNOSTIC_TEST

an ultrasound exam after selecting the best acoustic window, a region of interest (ROI) is placed in an area of the liver perpendicular to the liver capsule, taking care not to include large vasculature or biliary structures. Similarly an acoustic window will be selected for the pancreas as well

SIngle Arm

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age \<18 years
• Confirmed diagnosis of cystic fibrosis attending Pediatric cystic fibrosis (CF) Clinic at Children's Hospital, Winnipeg.

You may not qualify if:

• Children with age \>18 years

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Winnipeg Children's Hospital

Winnipeg, Manitoba, R3A 1S1, Canada

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Quais Mujawar

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quais Mujawar

CONTACT

204-787-4950; qmujawar@exchange.hsc.mb.ca

Vini Deora

CONTACT

204-787-4956; vdeora@exchange.hsc.mb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Gastroenterologist

Model Details: Patients (\<18 years) will be recruited from from the Children's Hospital Winnipeg CF clinic. Charts will be reviewed for demographic and clinical data including blood work. Each patient will undergo shear wave elastography by a trained operator.

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: August 29, 2017
• Study Start: October 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: January 31, 2018
• Last Updated: August 31, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)