HepatectomyESSURENCT03912844
European SIR-Spheres Surgical Registry
An observational study of Hepatectomy, run by Universitätsklinikum Köln at 1 site in Germany.
Trial summary
Liver resection is the only curative treatment option for primary and secondary liver tumors. For some primary or secondary malignancies (HCC, NET) liver transplantation is a possible treatment option. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatectomy
- What is being tested?
- SIRT followed by liver resection or liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jul 2019to 1 Jun 2024
- How long will I take part?
- 24 Months
- 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 are only asked to be enrolled when they are treated with SIR-Spheres microspheres followed by liver resection/liver transplantation or when SIRT has been performed with the intention to downsize/ downstage the tumor, to induce hypertrophy of the contralateral lobe, making the patient eligible for a future liver resection/transplantation. In no way will participation in the registry influence the way in which the patient is treated according to the treating clinician, or will it influence the quality of the treatment. If a patient is included in the registry, a documented decision of a multidisciplinary tumour board for the treatment algorithm including SIRT must be available. The follow-up periods depend on the treating clinician and local practice and guidelines. Typically, the follow ups are done every three months. So data of a single patient will be included over two years after the treatment.
Who may be able to join
- 18 years or older
- Primary or secondary liver tumors
- Treatment of liver tumors with SIR-Spheres Y-90 resin microspheres with the intention to make patient eligible for liver resection/liver transplantation
- Decision of a multidisciplinary tumor board on the patient's therapy regime
- Signed informed-consent form
Who cannot join
- under 18 years
- not able to sign informed consent
- no decision of a multidisciplinary tumorboard
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Cologne, Department of General, Visceral and Cancer Surgery
Cologne, 50931
Roger Wahba, MD, PHD, +492214784803, roger.wahba@uk-koeln.de
Roger Wahba, MD, PHD
About this study
Liver resection is the only curative treatment option for primary and secondary liver tumors. For some primary or secondary malignancies (HCC, NET) liver transplantation is a possible treatment option. Unfortunately, the majority of patients show a high hepatic tumor load or adverse intrahepatic distribution, that resection or transplantation at the time of initial diagnosis is not possible. In that case different treatment approaches are possible. For those patients that are very unlikely to ever become resectable, palliative systemic therapy is the preferred treatment option. For those patients that may become resectable after downsizing of the tumors or increase of volume of the future liver remnant secondary resection after induction therapy may be a possibility. Then, an induction treatment that has the most likelihood of causing physical shrinkage of the tumors is usually preferred. One of the approaches to create contralateral hypertrophy to increase future liver remnant is portal vein embolization. However, tumor growth might be stimulated during the phase of hypertrophy. Selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres is an endovascular interventional radio-oncologic procedure treating primary and secondary liver tumors1-3. It offers radiation therapy with yttrium-90, a high-energy beta-emitting isotope, directly in the vascular system of liver tumors. It treats the tumor locally, saves healthy liver tissue and could lead to hypertrophy of this residual healthy liver tissue due to the embolization effect. Therefore secondary liver resection after SIRT might become possible4,5. SIRT could also be an option as bridging-, downsizing- or downstaging-therapy before liver transplantation.
Liver resection with local tumor treatment and hypertrophy induction after SIRT seems to be a promising therapy option. Previous reports have shown the feasibility, safety and efficacy of this therapeutic strategy.
Aim of the European SIR-Spheres Surgical Registry - ESSURE - is now to further improve the understanding and optimize the process and patient selection of this therapy strategy in its true clinical setting. This registry enables data collection on the real-life clinical application of liver resection/liver transplantation after SIRT.
- Conditions
- Hepatectomy
- Being tested
- SIRT followed by liver resection or liver transplantation
- Keywords
- SIRT, liver resection, hypertrophy, liver metastases, liver transplantation
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIRT followed by liver resection or liver transplantationProcedure or surgery
The ESSURE registry is a prospective observational study. Patients are only asked to be enrolled when they are treated with SIR-Spheres microspheres followed by liver resection/liver transplantation or when SIRT has been performed with the intention to downsize/ downstage the tumor, to induce hypertrophy of the contralateral lobe, making the patient eligible for a future liver resection/transplantation. In no way will participation in the registry influence the way in which the patient is treated according to the treating clinician, or will it influence the quality of the treatment. If a patient is included in the registry, a documented decision of a multidisciplinary tumour board for the treatment algorithm including SIRT must be available. The follow-up periods depend on the treating clinician and local practice and guidelines. Typically, the follow ups are done every three months. So data of a single patient will be included over two years after the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Liver resection/liver transplantation after SIRT | The cohort consist of patients that, after decision of a multidisciplinary tumor board have received a SIRT/TARE or will receive a SIRT/TARE to make them later eligible for following liver resection or liver transplantation. Receives: Procedure: SIRT followed by liver resection or liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects that receive liver resection/liver transplantation after SIRT
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start25 Jul 2019
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatectomyStudies of the same condition, open and under way.
- 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
- 250 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Köln
- Sponsor type
- University, hospital or other
- Collaborators
- Sirtex Technology Pty LTD, Australia
- Responsible party
- Sponsor
- Investigators
- Christiane Bruns, MD, PhD, Study chair, Department of General, Visceral and Cancer Surgery, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912844
- Sponsor's protocol ID
- 18-337
- Acronym
- ESSURE
- Status last verified
- Mar 2022
- First submitted
- 3 Apr 2019
- Last updated
- 17 Mar 2022
- 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 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European SIR-Spheres Surgical Registry
- ClinicalTrials.gov ID
- NCT03912844
- Acronym / sponsor ID
- ESSURE / 18-337
- Conditions
- Hepatectomy
- Keywords
- SIRT, liver resection, hypertrophy, liver metastases, liver transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Universitätsklinikum KölnUniversity, hospital or other
- Collaborators
- Sirtex Technology Pty LTD, Australia
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 11 Apr 2019 (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.
Liver resection is the only curative treatment option for primary and secondary liver tumors. For some primary or secondary malignancies (HCC, NET) liver transplantation is a possible treatment option. Unfortunately, the majority of patients show a high hepatic tumor load or adverse intrahepatic distribution, that resection or transplantation at the time of initial diagnosis is not possible. In that case different treatment approaches are possible. For those patients that are very unlikely to ever become resectable, palliative systemic therapy is the preferred treatment option. For those patients that may become resectable after downsizing of the tumors or increase of volume of the future liver remnant secondary resection after induction therapy may be a possibility. Then, an induction treatment that has the most likelihood of causing physical shrinkage of the tumors is usually preferred. One of the approaches to create contralateral hypertrophy to increase future liver remnant is portal vein embolization. However, tumor growth might be stimulated during the phase of hypertrophy. Selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres is an endovascular interventional radio-oncologic procedure treating primary and secondary liver tumors1-3. It offers radiation therapy with yttrium-90, a high-energy beta-emitting isotope, directly in the vascular system of liver tumors. It treats the tumor locally, saves healthy liver tissue and could lead to hypertrophy of this residual healthy liver tissue due to the embolization effect. Therefore secondary liver resection after SIRT might become possible4,5. SIRT could also be an option as bridging-, downsizing- or downstaging-therapy before liver transplantation.
Liver resection with local tumor treatment and hypertrophy induction after SIRT seems to be a promising therapy option. Previous reports have shown the feasibility, safety and efficacy of this therapeutic strategy.
Aim of the European SIR-Spheres Surgical Registry - ESSURE - is now to further improve the understanding and optimize the process and patient selection of this therapy strategy in its true clinical setting. This registry enables data collection on the real-life clinical application of liver resection/liver transplantation after SIRT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver resection/liver transplantation after SIRT | – | Procedure: SIRT followed by liver resection or liver transplantationThe cohort consist of patients that, after decision of a multidisciplinary tumor board have received a SIRT/TARE or will receive a SIRT/TARE to make them later eligible for following liver resection or liver transplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are only asked to be enrolled when they are treated with SIR-Spheres microspheres followed by liver resection/liver transplantation or when SIRT has been performed with the intention to downsize/ downstage the tumor, to induce hypertrophy of the contralateral lobe, making the patient eligible for a future liver resection/transplantation. In no way will participation in the registry influence the way in which the patient is treated according to the treating clinician, or will it influence the quality of the treatment. If a patient is included in the registry, a documented decision of a multidisciplinary tumour board for the treatment algorithm including SIRT must be available. The follow-up periods depend on the treating clinician and local practice and guidelines. Typically, the follow ups are done every three months. So data of a single patient will be included over two years after the treatment.
Key inclusion criteria (5 listed)
- 18 years or older
- Primary or secondary liver tumors
- Treatment of liver tumors with SIR-Spheres Y-90 resin microspheres with the intention to make patient eligible for liver resection/liver transplantation
- Decision of a multidisciplinary tumor board on the patient's therapy regime
- Signed informed-consent form
Key exclusion criteria (3 listed)
- under 18 years
- not able to sign informed consent
- no decision of a multidisciplinary tumorboard
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 |
|---|---|---|
| SIRT followed by liver resection or liver transplantationThe ESSURE registry is a prospective observational study. Patients are only asked to be enrolled when they are treated with SIR-Spheres microspheres followed by liver resection/liver transplantation or when SIRT has been performed with the intention to downsize/ downstage the tumor, to induce hypertrophy of the contralateral lobe, making the patient eligible for a future liver resection/transplantation. In no way will participation in the registry influence the way in which the patient is treated according to the treating clinician, or will it influence the quality of the treatment. If a patient is included in the registry, a documented decision of a multidisciplinary tumour board for the treatment algorithm including SIRT must be available. The follow-up periods depend on the treating clinician and local practice and guidelines. Typically, the follow ups are done every three months. So data of a single patient will be included over two years after the treatment. | Procedure or surgery | Liver resection/liver transplantation after SIRT |
Primary outcome
Number of subjects that receive liver resection/liver transplantation after SIRT
Time frame: 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Christiane Bruns, MD, PhD study chair
Department of General, Visceral and Cancer Surgery, University of Cologne
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 Hepatectomy, run by Universitätsklinikum Köln at 1 site in Germany.
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 5 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 17 Mar 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 Germany. 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 Roger Wahba, MD, PhD (+49221474803, essure@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects that receive liver resection/liver transplantation after SIRT (time frame: 24 month). 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 17 Mar 2022.