European SIR-Spheres Surgical Registry (ESSURE)

Universitätsklinikum Köln

Status: Enrolling

Conditions: Hepatectomy

Treatments: Procedure: SIRT followed by liver resection or liver transplantation

Study type: Observational

Funder types: Other

Identifiers

NCT03912844

18-337

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 1 patient group

Liver resection/liver transplantation after SIRT

Description:

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.

Treatment:

Procedure: SIRT followed by liver resection or liver transplantation