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European SIR-Spheres Surgical Registry (ESSURE)

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ClinicalTrials.gov Identifier: NCT03912844
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : October 9, 2019
Sponsor:
Collaborator:
Sirtex Technology Pty LTD, Australia
Information provided by (Responsible Party):
Universitätsklinikum Köln

Brief 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. 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.


Condition or disease Intervention/treatment
Hepatectomy Procedure: SIRT followed by liver resection or liver transplantation

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: European SIR-Spheres Surgical Registry
Actual Study Start Date : July 25, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Liver resection/liver transplantation after SIRT
The cohort consist of patients that have after decision of a multidisciplinary tumorboard received a SIRT tor made them later eligible for following liver resection or liver transplantation.
Procedure: SIRT followed by liver resection or liver transplantation
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.




Primary Outcome Measures :
  1. Number of subjects that receive liver resction/liver transplantation after SIRT [ Time Frame: 24 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • under 18 years
  • not able to sign informed consent
  • no decision of a multidisciplinary tumorboard

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912844


Contacts
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Contact: Roger Wahba, MD, PhD +49221474803 essure@uk-koeln.de

Locations
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Germany
University of Cologne, Department of General, Visceral and Cancer Surgery Recruiting
Cologne, Germany, 50931
Contact: Roger Wahba, MD, PHD    +492214784803    roger.wahba@uk-koeln.de   
Principal Investigator: Roger Wahba, MD, PHD         
Sub-Investigator: Data Rabi, MD         
Sponsors and Collaborators
Universitätsklinikum Köln
Sirtex Technology Pty LTD, Australia
Investigators
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Study Chair: Christiane Bruns, MD, PhD Department of General, Visceral and Cancer Surgery, University of Cologne

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Responsible Party: Universitätsklinikum Köln
ClinicalTrials.gov Identifier: NCT03912844     History of Changes
Other Study ID Numbers: 18-337
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitätsklinikum Köln:
SIRT
liver resection
hypertrophy
liver metastases
liver transplantation
Additional relevant MeSH terms:
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Liver Extracts
Hematinics