Splenomegaly; Congestive, ChronicNCT05050994
Ultrasound Guided Microwave Ablation of Splenomegaly in Children
A study testing Microwave ablation in people with Splenomegaly; Congestive, Chronic and Panhematopenia; Splenic, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Splenomegaly; Congestive, Chronic, Panhematopenia; Splenic, Portal Hypertension
- What is being tested?
- Microwave ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2021to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Age younger than 10 or older than 17 years of age
- Legal guardians or child do not give consent
- Ongoing infection
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 17177
Thomas Casswall, MD. PhD.
About this study
Official title: Ultrasound Guided Partial Microwave Ablation of the Spleen Due to Secondary Splenomegaly in Children - a Study of Feasibility and Acceptability
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.
Read the 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.
- Being tested
- Microwave ablation
- Keywords
- Microwave ablation
- Medical subject headings
- Splenomegaly, Bronchiolitis Obliterans Syndrome, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave ablationProcedure or surgery
Children with symptomatic secondary splenomegaly will receive partial microwave ablation of spleen (up to 40-50% of total volume)
| Study group | Role | What they receive |
|---|---|---|
| Microwave ablation | Experimental | Patients receiving microwave ablation of splenomegaly Receives: Procedure: Microwave ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet count
Difference between platelet count before MWA and at 1, 3, 6 and 12 months after treatment
Measured: Base line and 1, 3, 6 and 12 months follow up
Secondary outcomes (8)
Number of MWA
Number of MWA to achieve goal with platelet count > 50 x 109 cells/L or reducing functional spleen with 50%
Measured: Within 12 months
Effect on blood cell count
Effect on red and white blood cell count
Measured: Base line and 1, 3, 6 and 12 months follow up
Effect on liver function
Measurement of AST, ALT, ALP, GGT, bilirubin, cholinesterase, albumin, ammonia
Measured: Base line and 1, 3, 6 and 12 months follow up
Effect on coagulation
Measurement of PT-INR, APTT, D-dimer, fibrinogen, ROTEM with fibrinogen, antithrombin, von Willebrand activity (vWGP1bA), factor VIII enzyme
Measured: Base line and 1, 3, 6 and 12 months follow up
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.
Measured: Day of surgury and the following 7 days
Use of analgesic drugs
The administration of standardized analgesic drugs will be recorded
Measured: Day of surgury and the following 7 days
Days of hospitalization
How many days the patient stays in hospital after ablation
Measured: 1 month
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
Measured: 1 month after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start1 Mar 2021
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Splenomegaly; Congestive, ChronicStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective observational pilot trial
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Casswall, Karolinska Institutet
- Investigators
- Thomas Casswell, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050994
- Sponsor's protocol ID
- 2020-06155
- Status last verified
- Sep 2021
- First submitted
- 10 Sep 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Partial Microwave Ablation of the Spleen Due to Secondary Splenomegaly in Children - a Study of Feasibility and Acceptability
- ClinicalTrials.gov ID
- NCT05050994
- Acronym / sponsor ID
- 2020-06155
- Keywords
- Microwave ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective observational pilot trial
| Arm | Type | Receives |
|---|---|---|
| Microwave ablation | Experimental | Procedure: Microwave ablationPatients receiving microwave ablation of splenomegaly |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Age younger than 10 or older than 17 years of age
- Legal guardians or child do not give consent
- Ongoing infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microwave ablationChildren with symptomatic secondary splenomegaly will receive partial microwave ablation of spleen (up to 40-50% of total volume) | Procedure or surgery | Microwave ablation |
Primary outcome
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
8 secondary outcomes
Number of MWA
Time frame: Within 12 months
Effect on blood cell count
Time frame: Base line and 1, 3, 6 and 12 months follow up
Effect on liver function
Time frame: Base line and 1, 3, 6 and 12 months follow up
Effect on coagulation
Time frame: Base line and 1, 3, 6 and 12 months follow up
Maximal pain
Time frame: Day of surgury and the following 7 days
Use of analgesic drugs
Time frame: Day of surgury and the following 7 days
Days of hospitalization
Time frame: 1 month
Acceptability of treatment
Time frame: 1 month after ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Casswell, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave ablation in people with Splenomegaly; Congestive, Chronic and Panhematopenia; Splenic, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Casswall, MD, PhD (+46 8 58581464, thomas.casswall@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet count (time frame: Base line and 1, 3, 6 and 12 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.