Ultrasound Guided Microwave Ablation of Splenomegaly in Children

NCT05050994 | Unknown

• 1 other identifier: 2020-06155
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Microwave ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of MWA

  Within 12 months

• Effect on blood cell count

  Base line and 1, 3, 6 and 12 months follow up

• Effect on liver function

  Base line and 1, 3, 6 and 12 months follow up

• Effect on coagulation

  Base line and 1, 3, 6 and 12 months follow up

• Maximal pain

  Day of surgury and the following 7 days

Study Arms (1)

Microwave ablation

EXPERIMENTAL

Patients receiving microwave ablation of splenomegaly

Procedure: Microwave ablation

Interventions

Microwave ablation PROCEDURE

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

Microwave ablation

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Age younger than 10 or older than 17 years of age
• Legal guardians or child do not give consent
• Ongoing infection

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 17177, Sweden

RECRUITING

MeSH Terms

Conditions

Splenomegaly; Bronchiolitis Obliterans Syndrome; Hypertension, Portal

Condition Hierarchy (Ancestors)

Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Liver Diseases; Digestive System Diseases

Study Officials

• Thomas Casswell, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Casswall, MD, PhD

CONTACT

+46 8 58581464; thomas.casswall@ki.se

Marie Beermann, MD.

CONTACT

+46 8 12357843; marie.beermann@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Prospective observational pilot trial

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 21, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: February 1, 2025
• Last Updated: January 4, 2022

Record last verified: 2021-09

Locations

SE (1)