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Recruiting NCT07445412

Italian Group of Regenerative and Occlusive Worldwide-used Techniques of Hepatic Hypertrophy

Observational Liver Tumours Liver Cancer (Primary and Metastatic) Liver Resection Liver Hypertrophy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Liver Tumours, Liver Cancer (Primary and Metastatic), Liver Resection, Liver Hypertrophy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Italian Group of Regenerative and Occlusive Worldwide-used Techniques of Hepatic Hypertrophy - IGROWtoh

Overview

The goal of this national mutlticenter observational study is to learn and describe trends over time in the use of techniques for inducing hepatic hypertrophy in Italy. Patients will be treated according to the current clinical practice of the participating centers and will be observed from the moment of recruitment and throughout their stay. Information on vital status will be collected, as far as possible, for up to 5 years after surgery in order to record any events that occur in a timely manner. There are also plans to retrospectively collect data on patients who underwent hypertrophic techniques in the previous 10 years, in order to establish a historical cohort for each center that can be used for comparison with the prospective cohort.

Primary outcome measures

  • Describe the temporal trends in the use of techniques for inducing hepatic hypertrophy in Italy [Time frame: through study completion, an average of 1 year]
  • compare the techniques used in terms of function and volumetric hypertrophy [Time frame: through study completion, an average of 1 year]
  • compare the techniques used in terms of drop-out [Time frame: through study completion, an average of 1 year]
  • compare the techniques used in terms of 90-day mortality [Time frame: through study completion, an average of 1 year]
  • compare the techniques used in terms of long-term survival [Time frame: through study completion, an average of 1 year]
  • compare the techniques used in terms of disease-free survival [Time frame: through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • Patients aged 18 or older
  • Obtaining informed consent
  • Patients with liver neoplasia (benign or malignant) and with a future liver remnant volume deemed insufficient (<20%-40%) by the local multidisciplinary team

Exclusion criteria

  • pregnant or breastfeeding woman

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Azienda Ospedaliero-Universitario di Bologna — Bologna

Identifiers

NCT: NCT07445412 · I-GROWtoh

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗