Isolated Limb PerfusionMI-ILPNCT03376126
Minimally-Invasive Isolated Limb Perfusion
An observational study of Isolated Limb Perfusion, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
The aim is to analyse feasibility of a minimally-invasive isolated limb perfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Isolated Limb Perfusion
- What is being tested?
- Minimal-invasive isolated limb perfusion
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2016to 15 Jun 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for isolated limb perfusion.
Who may be able to join
- The patient scheduled for treatment with isolated hyperthermic perfusion
- Age over 18 years.
- Signed informed consent
Who cannot join
- Re-perfusion
- Lymph node metastases
- Severe atherosclerosis
Trial locations and contacts
1 site in 1 country.
About this study
The aim is to analyse feasibility of a minimally-invasive isolated limb perfusion.
Read the detailed description
Isolated limb perfusion (ILP) and isolated limb infusion (ILI) are treatment options for patients with in-transit metastases of melanoma and locally advanced extremity sarcomas. There are several advantages for each method, but if the well-established effects of ILP could be combined to the minimally invasive approach of ILI, the results could be maximized and adverse events, related to open approach, minimized.
A new method for vascular approach (MI-ILP) will be evaluated in a phase I feasibility study. Percutaneous vascular access of the ipsilateral side will be performed by ultrasound guided technique and connected to an extracorporeal oxygenation system. Perfusion will be conducted in the same way as for open ILP. Outcomes, technical details and complications will be recorded prospectively.
- Conditions
- Isolated Limb Perfusion
- Being tested
- Minimal-invasive isolated limb perfusion
- Keywords
- isolated limb perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal-invasive isolated limb perfusionOther
Minimal-invasive isolated limb perfusion
| Study group | Role | What they receive |
|---|---|---|
| MI-ILP | Not described Receives: Other: Minimal-invasive isolated limb perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion to open surgery
Number of minimal-invasive procedure that will be converted to open surgery (per cent)
Measured: 1 day
Secondary outcomes (2)
Response
Clinical response rate according to WHO criteria.
Measured: 3 months
Complications
Complications according to Clavien-Dindo
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start1 Jun 2016
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Isolated Limb PerfusionStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Roger Olofsson Bagge, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376126
- Sponsor's protocol ID
- MI-ILP
- Acronym
- MI-ILP
- Status last verified
- Aug 2026
- First submitted
- 8 Dec 2017
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally-Invasive Isolated Limb Perfusion
- ClinicalTrials.gov ID
- NCT03376126
- Acronym / sponsor ID
- MI-ILP / MI-ILP
- Conditions
- Isolated Limb Perfusion
- Keywords
- isolated limb perfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 18 Dec 2017 (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.
The aim is to analyse feasibility of a minimally-invasive isolated limb perfusion.
Detailed description
Isolated limb perfusion (ILP) and isolated limb infusion (ILI) are treatment options for patients with in-transit metastases of melanoma and locally advanced extremity sarcomas. There are several advantages for each method, but if the well-established effects of ILP could be combined to the minimally invasive approach of ILI, the results could be maximized and adverse events, related to open approach, minimized.
A new method for vascular approach (MI-ILP) will be evaluated in a phase I feasibility study. Percutaneous vascular access of the ipsilateral side will be performed by ultrasound guided technique and connected to an extracorporeal oxygenation system. Perfusion will be conducted in the same way as for open ILP. Outcomes, technical details and complications will be recorded prospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MI-ILP | – | Other: Minimal-invasive isolated limb perfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for isolated limb perfusion.
Key inclusion criteria (3 listed)
- The patient scheduled for treatment with isolated hyperthermic perfusion
- Age over 18 years.
- Signed informed consent
Key exclusion criteria (3 listed)
- Re-perfusion
- Lymph node metastases
- Severe atherosclerosis
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 |
|---|---|---|
| Minimal-invasive isolated limb perfusionMinimal-invasive isolated limb perfusion | Other | MI-ILP |
Primary outcome
Conversion to open surgery
Time frame: 1 day
Number of minimal-invasive procedure that will be converted to open surgery (per cent)
2 secondary outcomes
Response
Time frame: 3 months
Complications
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Isolated Limb Perfusion
Active, not recruiting
Comparative Effectiveness of Nursing Interventions: Using Buerger-Allen Exercises Versus Mechanical Compression Therapy on Lower Limb Perfusion and Peripheral Neuropathy Among Patients Undergoing Chemotherapy.
Polyneuropathies, Regional Blood Flow
RecruitingPhase 2
A Study of Pembrolizumab Plus Local Chemotherapy Using Isolated Limb Infusion (ILI) for Patients With Sarcoma in the Arm or Leg
Sarcoma, Myxofibrosarcoma
RecruitingPhase 1/2
Evaluating the Effect of Nivolumab for Patients With In-transit Metastases Treated With Isolated Limb Perfusion
Melanoma, In-Transit Metastasis
Recruiting
Augmentation of Limb Perfusion With Contrast Ultrasound
Peripheral Arterial Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Isolated Limb Perfusion, run by Vastra Gotaland Region 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 3 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: finished, as of the sponsor's last update on 19 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion to open surgery (time frame: 1 day). 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 19 Aug 2026.