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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Children with symptomatic secondary splenomegaly will receive partial microwave ablation of spleen (up to 40-50% of total volume)
Karolinska University Hospital
Stockholm, Sweden
RECRUITINGPlatelet count
Difference between platelet count before MWA and at 1, 3, 6 and 12 months after treatment
Time frame: Base line and 1, 3, 6 and 12 months follow up
Number of MWA
Number of MWA to achieve goal with platelet count \> 50 x 109 cells/L or reducing functional spleen with 50%
Time frame: Within 12 months
Effect on blood cell count
Effect on red and white blood cell count
Time frame: Base line and 1, 3, 6 and 12 months follow up
Effect on liver function
Measurement of AST, ALT, ALP, GGT, bilirubin, cholinesterase, albumin, ammonia
Time frame: Base line and 1, 3, 6 and 12 months follow up
Effect on coagulation
Measurement of PT-INR, APTT, D-dimer, fibrinogen, ROTEM with fibrinogen, antithrombin, von Willebrand activity (vWGP1bA), factor VIII enzyme
Time frame: Base line and 1, 3, 6 and 12 months follow up
Maximal pain
Measured using the Visual Analog Scale, a numerical rating scale from 0 - 10 where 0 is no pain and 10 is worst imaginable pain.
Time frame: Day of surgury and the following 7 days
Use of analgesic drugs
The administration of standardized analgesic drugs will be recorded
Time frame: Day of surgury and the following 7 days
Days of hospitalization
How many days the patient stays in hospital after ablation
Time frame: 1 month
Acceptability of treatment
Measured as parents preferred future treatment and as if the method could be recommended to a family with a child with a similar medical condition
Time frame: 1 month after ablation
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