Using Ultrasound Elastography to Predict Development of SOS

Sinusoidal Obstruction Syndrome Clinical Trial

Official title:

Using Ultrasound Elastography to Predict Development of Sinusoidal Obstruction Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02483481
• Other study ID #: IRB # 15060244
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: December 2018

Study information

• Verified date: January 2024
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sinusoidal obstruction syndrome (SOS) is a potentially fatal hepatic veno-occlusive disease-affecting children following bone marrow transplantation (BMT). SOS most likely develops secondary to sinusoidal endothelial damage and subsequent obstruction. The disease can be separated into mild, moderate, and severe forms; almost all patients diagnosed with severe SOS will die from this disease. Children with severe SOS suffer from multi-organ failure with signs and symptoms of portal hypertension (ascites, varices, edema), renal and respiratory failure . Although these children may be few and far between, the mere severity of the disease process and awful prognosis factors are valid reasons for more medical attention. SOS is usually diagnosed via clinical criteria and, despite available prophylaxis and treatment, children continue to die from this devastating disease.

Quantitative shear wave ultrasound elastography with acoustic force radiation imaging is an emerging technology that uses ultrasound pressure waves to provide an estimate of tissue stiffness. This technique is promising for pediatric imaging because it is portable, quick to perform, relatively low cost and involves no ionizing radiation. Acoustic force radiation imaging and ultrasound elastography does not have any increased risks over conventional ultrasound imaging.

Description:

This is a single site prospective cohort study that will compare ultrasound elastography to traditional ultrasound parameters in bone marrow transplant patients who are at risk for development of SOS.

• Primary objective: compare sensitivity and specificity of traditional ultrasound parameters and ultrasound elastography of the liver for detecting SOS in BMT patients.

• Secondary objectives: 1. compare sensitivity and specificity of traditional ultrasound parameters and ultrasound elastography of the liver for classifying SOS in BMT patients.

2. compare sensitivity and specificity of traditional ultrasound parameters and ultrasound elastography of the liver for predicting death in BMT patients with SOS (defined as death within 100 days of transplant).

• The validity and reliability of the primary and secondary measures when available. The validity of the measures will be determined by comparing to clinical gold standards of the diagnosis and classification of SOS

Data Collection Procedures

• Candidates for the study will be identified by the Hematology Oncology service when they are admitted for bone marrow transplant.

• A member of the study team will consent that patient and/or their parents once the patient has been identified.

• If the patient consents to the study, an initial limited abdominal ultrasound with Doppler and shear wave elastography will be performed less than one month prior to bone marrow transplant. Demographic and clinical variables will be collected from the chart at the time of initial ultrasound and after date of discharge. Lab value variables will be collected at the time of the initial ultrasound and during all subsequent ultrasounds. Only lab values that have changed since the prior ultrasound will be recorded.

• Multiple shear wave elastography measurements of the liver will be obtained during any post-transplant clinical abdominal ultrasound Data Analyses We will perform two-sided t-tests and nonparametric tests for categorical and continuous data, respectively. Additionally, we will perform a multivariate regression to determine which variables are significantly correlated to death and calculate an odds ratio for each of these variables. If a patient is missing any imaging or clinical data, then this patient will be excluded from those parts of the data analysis, but the rest of their data will still be included in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

Inclusion Criteria:

• All patients who are admitted for BMT from the date of study approval until patient accrual is met.

Exclusion Criteria:

• BMT patients who do not end up undergoing transplant during that admission. BMT patients who do not receive any abdominal ultrasounds post transplantation BMT patients who do not consent to the study.

Related Conditions & MeSH terms

• Complications of Bone Marrow Transplant
• Hepatic Veno-Occlusive Disease
• Sinusoidal Obstruction Syndrome
• Syndrome

Intervention

Diagnostic Test:
• shear wave ultrasound elastography
shear wave ultrasound elastography

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

References & Publications (20)

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Shiina T, Nightingale KR, Palmeri ML, Hall TJ, Bamber JC, Barr RG, Castera L, Choi BI, Chou YH, Cosgrove D, Dietrich CF, Ding H, Amy D, Farrokh A, Ferraioli G, Filice C, Friedrich-Rust M, Nakashima K, Schafer F, Sporea I, Suzuki S, Wilson S, Kudo M. WFUMB guidelines and recommendations for clinical use of ultrasound elastography: Part 1: basic principles and terminology. Ultrasound Med Biol. 2015 May;41(5):1126-47. doi: 10.1016/j.ultrasmedbio.2015.03.009. Epub 2015 Mar 21. — View Citation

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* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and Specificity of US for VOD/SOS		within 100 days of bone marrow transplant
Secondary	Severity of SOS	death as noted in medical record	within 100 days of bone marrow transplant