Ultrasound Guided Microwave Ablation of Splenomegaly in Children
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Details and patient eligibility
About
Children with liver cirrhosis frequently develops portal hypertension. One of the serious complications to portal hypertension is splenomegaly, which may result in pancytopenia, especially thrombocytopenia that may cause bleeding tendencies.
Symptomatic splenomegaly is often treated with partial splenic embolization (PSE). PSE is effective but may give rise to postembolization syndrome not well tolerated in the pediatric population. In adults, microwave ablation (MWA) has been used to treat splenomegaly with promising results but with less post-operative pain. Our study is a pilot trial to evaluate the feasibility and acceptability of this treatment in children.
Full description
The ablation will be performed under general anesthesia by an experienced interventional radiologist. Ultrasound will be used for peri-operative assessment and the microwave antenna will be inserted under ultrasound guidance focusing on the middle to inferior part of the spleen to avoid harm to the diaphragm. After the emission of microwaves for up to 5 minutes, the antenna will be pulled back and the emission will be repeated until the ablation zone is approximately 1 cm from the splenic surface. In this way, two or three overlapping areas will be ablated with every insertion of the antenna. The ablation zones will be visible as hyperechoic areas on b-mode ultrasound during operation, and the goal is to ablate up to 40-50% of the total volume of the spleen (as estimated by the radiologist). If the ablated volume is less than 40-50% at follow up, the procedure can be repeated in a second session for additional effect.
Enrollment
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Volunteers
Inclusion criteria
- Spleen length > +2 standard deviations of normal limit
- Platelet count below 30-35 x 109 cells/L and a history of bleeding tendencies
- Symptoms of portal hypertension such as splenomegaly, thrombocytopenia, leucopenia, ascites, esophageal or gastric varices, hypertensive gastropathy, anal hemorrhoids and increased portal scintigraphy index, where alternative methods have not been enough or suitable
- A necessity for reduction of splenic volume due to splenic inhibition of motion and activity in the child
Exclusion criteria
- Age younger than 10 or older than 17 years of age
- Legal guardians or child do not give consent
- Ongoing infection
Trial design
Primary purpose
Allocation
Interventional model
Masking
10 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Marie Beermann, MD.; Thomas Casswall, MD, PhD
Data sourced from clinicaltrials.gov
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