European SIR-Spheres Surgical Registry (ESSURE)

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 Overview

• Status: Recruiting
• Conditions: Hepatectomy
• Intervention / Treatment: Procedure: SIRT followed by liver resection or liver transplantation

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Roger Wahba, MD, PhD; Phone Number: +49221474803; Email: essure@uk-koeln.de

Study Locations

• Germany
  • Cologne, Germany, 50931
    • Recruiting
    • University of Cologne, Department of General, Visceral and Cancer Surgery
    • Principal Investigator: Roger Wahba, MD, PHD
    • Sub-Investigator: Data Rabi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of subjects that receive liver resection/liver transplantation after SIRT	24 month

Collaborators and Investigators

• Sponsor: Universitätsklinikum Köln
• Collaborators: Sirtex Technology Pty LTD, Australia
• Investigators: Study Chair: Christiane Bruns, MD, PhD, Department of General, Visceral and Cancer Surgery, University of Cologne

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2019
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: liver transplantation; liver metastases; liver resection; SIRT; hypertrophy
• Other Study ID Numbers: 18-337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No