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Using Ultrasound Elastography to Predict Development of SOS

Using Ultrasound Elastography to Predict Development of Sinusoidal Obstruction Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02483481
Enrollment
45
Registered
2015-06-29
Start date
2015-08-31
Completion date
2018-12-31
Last updated
2024-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications of Bone Marrow Transplant, Sinusoidal Obstruction Syndrome

Keywords

sinusoidal obstruction syndrome, ultrasound elastography, bone marrow transplant

Brief 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.

Detailed 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.

Interventions

shear wave ultrasound elastography

Sponsors

Children's Mercy Hospital Kansas City
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Sensitivity and Specificity of US for VOD/SOSwithin 100 days of bone marrow transplant

Secondary

MeasureTime frameDescription
Severity of SOSwithin 100 days of bone marrow transplantdeath as noted in medical record

Countries

United States

Participant flow

Participants by arm

ArmCount
Shear Wave Ultrasound Elastography
shear wave ultrasound elastography: shear wave ultrasound elastography
45
Total45

Baseline characteristics

CharacteristicShear Wave Ultrasound Elastography
Age, Categorical
<=18 years
35 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
2 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
35 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
3 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants
Race (NIH/OMB)
Unknown or Not Reported
12 Participants
Race (NIH/OMB)
White
28 Participants
Region of Enrollment
United States
45 participants
Sex: Female, Male
Female
21 Participants
Sex: Female, Male
Male
24 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
11 / 45
other
Total, other adverse events
0 / 45
serious
Total, serious adverse events
0 / 45

Outcome results

Primary

Sensitivity and Specificity of US for VOD/SOS

Time frame: within 100 days of bone marrow transplant

ArmMeasureGroupValue (NUMBER)
Shear Wave Ultrasound ElastographySensitivity and Specificity of US for VOD/SOSSensitivity80 percentage of participants
Shear Wave Ultrasound ElastographySensitivity and Specificity of US for VOD/SOSSpecificity93 percentage of participants
Secondary

Severity of SOS

death as noted in medical record

Time frame: within 100 days of bone marrow transplant

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Shear Wave Ultrasound ElastographySeverity of SOS2 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026