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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05050994
Other study ID # 2020-06155
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date February 1, 2025

Study information

Verified date September 2021
Source Karolinska Institutet
Contact Thomas Casswall, MD, PhD
Phone +46 8 58581464
Email thomas.casswall@ki.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date February 1, 2025
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 10 Years to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Microwave ablation
Children with symptomatic secondary splenomegaly will receive partial microwave ablation of spleen (up to 40-50% of total volume)

Locations

Country Name City State
Sweden Karolinska University Hospital Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Platelet count Difference between platelet count before MWA and at 1, 3, 6 and 12 months after treatment Base line and 1, 3, 6 and 12 months follow up
Secondary Number of MWA Number of MWA to achieve goal with platelet count > 50 x 109 cells/L or reducing functional spleen with 50% Within 12 months
Secondary Effect on blood cell count Effect on red and white blood cell count Base line and 1, 3, 6 and 12 months follow up
Secondary Effect on liver function Measurement of AST, ALT, ALP, GGT, bilirubin, cholinesterase, albumin, ammonia Base line and 1, 3, 6 and 12 months follow up
Secondary Effect on coagulation Measurement of PT-INR, APTT, D-dimer, fibrinogen, ROTEM with fibrinogen, antithrombin, von Willebrand activity (vWGP1bA), factor VIII enzyme Base line and 1, 3, 6 and 12 months follow up
Secondary 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. Day of surgury and the following 7 days
Secondary Use of analgesic drugs The administration of standardized analgesic drugs will be recorded Day of surgury and the following 7 days
Secondary Days of hospitalization How many days the patient stays in hospital after ablation 1 month
Secondary 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 1 month after ablation
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