Ultrasound Guided Microwave Ablation of Splenomegaly in C... | NCT05050994

Studies
Ultrasound Guided Microwave Ablation of Splenomegaly in Children

NCT05050994

Sponsor

Karolinska Institutet

Status

Unknown status

Last Update Posted

Jan 4, 2022Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Splenomegaly; Congestive, Chronic
Panhematopenia; Splenic
Portal Hypertension

Interventions

Microwave ablation

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Mar 1, 2024Estimated

Completion Date

Feb 1, 2025Estimated

First Submitted Date

Sep 10, 2021

First Submission Date that Met QC Criteria

Sep 10, 2021

First Posted Date

Sep 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2021

Last Update Posted Date

Jan 4, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thomas Casswall, Clinical Professor, Karolinska InstitutetPrincipal Investigator

Lead Sponsor

Karolinska InstitutetOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Microwave ablation	Experimental	Patients receiving microwave ablation of splenomegaly	Procedure: Microwave ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Microwave ablation	Procedure	Children with symptomatic secondary splenomegaly will receive partial microwave ablation of spleen (up to 40-50% of total volume)	Microwave ablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Effect on blood cell count	Effect on red and white blood cell count

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thomas Casswall, MD, PhD	Contact	+46 8 58581464		thomas.casswall@ki.se
Marie Beermann, MD.	Contact	+46 8 12357843		marie.beermann@ki.se

Overall Officials

Name	Affiliation	Role
Thomas Casswell, MD, PhD	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska University Hospital	Recruiting	Stockholm		17177	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D013163	Splenomegaly
D000092122	Bronchiolitis Obliterans Syndrome
D006975	Hypertension, Portal

Ancestor Terms

ID	Term
D006984	Hypertrophy
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D000092124	Organizing Pneumonia

Browse Leaves

Not provided

Browse Branches

Not provided