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Ultrasound Guided Microwave Ablation of Splenomegaly in Children

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ClinicalTrials.gov Identifier: NCT05050994
Recruitment Status : Recruiting
First Posted : September 21, 2021
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
Thomas Casswall, Karolinska Institutet

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.


Condition or disease Intervention/treatment Phase
Splenomegaly; Congestive, Chronic Panhematopenia; Splenic Portal Hypertension Procedure: Microwave ablation Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective observational pilot trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultrasound Guided Partial Microwave Ablation of the Spleen Due to Secondary Splenomegaly in Children - a Study of Feasibility and Acceptability
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : February 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Microwave ablation
Patients receiving microwave ablation of splenomegaly
Procedure: Microwave ablation
Children with symptomatic secondary splenomegaly will receive partial microwave ablation of spleen (up to 40-50% of total volume)




Primary Outcome Measures :
  1. Platelet count [ Time Frame: Base line and 1, 3, 6 and 12 months follow up ]
    Difference between platelet count before MWA and at 1, 3, 6 and 12 months after treatment


Secondary Outcome Measures :
  1. Number of MWA [ Time Frame: Within 12 months ]
    Number of MWA to achieve goal with platelet count > 50 x 109 cells/L or reducing functional spleen with 50%

  2. Effect on blood cell count [ Time Frame: Base line and 1, 3, 6 and 12 months follow up ]
    Effect on red and white blood cell count

  3. Effect on liver function [ Time Frame: Base line and 1, 3, 6 and 12 months follow up ]
    Measurement of AST, ALT, ALP, GGT, bilirubin, cholinesterase, albumin, ammonia

  4. Effect on coagulation [ Time Frame: Base line and 1, 3, 6 and 12 months follow up ]
    Measurement of PT-INR, APTT, D-dimer, fibrinogen, ROTEM with fibrinogen, antithrombin, von Willebrand activity (vWGP1bA), factor VIII enzyme

  5. Maximal pain [ Time Frame: Day of surgury and the following 7 days ]
    Measured using a numerical rating scale from 0 - 10

  6. Use of analgesic drugs [ Time Frame: Day of surgury and the following 7 days ]
    The administration of standardized analgesic drugs will be recorded

  7. Days of hospitalization [ Time Frame: 1 month ]
    How many days the patient stays in hospital after ablation

  8. Acceptability of treatment [ Time Frame: 1 month after ablation ]
    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



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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05050994


Contacts
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Contact: Thomas Casswall, MD, PhD +46 8 58581464 thomas.casswall@ki.se
Contact: Marie Beermann, MD. +46 8 12357843 marie.beermann@ki.se

Locations
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Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, 17177
Contact: Thomas Casswall, MD. PhD.         
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Thomas Casswell, MD, PhD Karolinska Institutet
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Responsible Party: Thomas Casswall, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT05050994    
Other Study ID Numbers: 2020-06155
First Posted: September 21, 2021    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Casswall, Karolinska Institutet:
Microwave ablation
Additional relevant MeSH terms:
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Hypertension, Portal
Splenomegaly
Liver Diseases
Digestive System Diseases
Hypertrophy
Pathological Conditions, Anatomical