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Ultrasound Guided Microwave Ablation of Splenomegaly in Children

NCT05050994 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-01-04

No results posted yet for this study

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.

Conditions

  • Splenomegaly; Congestive, Chronic
  • Panhematopenia; Splenic
  • Portal Hypertension

Interventions

PROCEDURE

Microwave ablation

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

Sponsors & Collaborators

Principal Investigators

  • Thomas Casswell, MD, PhD · Karolinska Institutet

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2024-03-01
Completion
2025-02-01

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05050994 on ClinicalTrials.gov