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Ultrasound Guided Microwave Ablation of Splenomegaly in Children

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Microwave ablation
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Splenomegaly; Congestive, Chronic focused on measuring Microwave ablation

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Microwave ablation

Arm Description

Patients receiving microwave ablation of splenomegaly

Outcomes

Primary Outcome Measures

Platelet count
Difference between platelet count before MWA and at 1, 3, 6 and 12 months after treatment

Secondary Outcome Measures

Number of MWA
Number of MWA to achieve goal with platelet count > 50 x 109 cells/L or reducing functional spleen with 50%
Effect on blood cell count
Effect on red and white blood cell count
Effect on liver function
Measurement of AST, ALT, ALP, GGT, bilirubin, cholinesterase, albumin, ammonia
Effect on coagulation
Measurement of PT-INR, APTT, D-dimer, fibrinogen, ROTEM with fibrinogen, antithrombin, von Willebrand activity (vWGP1bA), factor VIII enzyme
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.
Use of analgesic drugs
The administration of standardized analgesic drugs will be recorded
Days of hospitalization
How many days the patient stays in hospital after ablation
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

Full Information

First Posted
September 10, 2021
Last Updated
December 30, 2021
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT05050994
Brief Title
Ultrasound Guided Microwave Ablation of Splenomegaly in Children
Official Title
Ultrasound Guided Partial Microwave Ablation of the Spleen Due to Secondary Splenomegaly in Children - a Study of Feasibility and Acceptability
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Splenomegaly; Congestive, Chronic, Panhematopenia; Splenic, Portal Hypertension
Keywords
Microwave ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective observational pilot trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Microwave ablation
Arm Type
Experimental
Arm Description
Patients receiving microwave ablation of splenomegaly
Intervention Type
Procedure
Intervention Name(s)
Microwave ablation
Intervention Description
Children with symptomatic secondary splenomegaly will receive partial microwave ablation of spleen (up to 40-50% of total volume)
Primary Outcome Measure Information:
Title
Platelet count
Description
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
Secondary Outcome Measure Information:
Title
Number of MWA
Description
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
Title
Effect on blood cell count
Description
Effect on red and white blood cell count
Time Frame
Base line and 1, 3, 6 and 12 months follow up
Title
Effect on liver function
Description
Measurement of AST, ALT, ALP, GGT, bilirubin, cholinesterase, albumin, ammonia
Time Frame
Base line and 1, 3, 6 and 12 months follow up
Title
Effect on coagulation
Description
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
Title
Maximal pain
Description
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
Title
Use of analgesic drugs
Description
The administration of standardized analgesic drugs will be recorded
Time Frame
Day of surgury and the following 7 days
Title
Days of hospitalization
Description
How many days the patient stays in hospital after ablation
Time Frame
1 month
Title
Acceptability of treatment
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Casswall, MD, PhD
Phone
+46 8 58581464
Email
thomas.casswall@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Beermann, MD.
Phone
+46 8 12357843
Email
marie.beermann@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Casswell, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
17177
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Casswall, MD. PhD.

12. IPD Sharing Statement

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Ultrasound Guided Microwave Ablation of Splenomegaly in Children

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