Italian Group of Regenerative and Occlusive Worldwide-used Techniques of Hepatic Hypertrophy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
pregnant or breastfeeding woman
Trial population
The study population includes patients with potentially resectable primary or secondary liver tumors. An anatomical-pathological situation is defined as potentially resectable if a small residual liver requires regenerative procedures prior to liver resection to avoid the risk of post-resection liver failure
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
2,000 Participants
are grouped into 2 trial groupsGroup A: Prospective cohort
Group B: Retrospective Cohort
Trial outcomes
Primary outcomes
1
Describe the temporal trends in the use of techniques for inducing hepatic hypertrophy in Italy
Time frame
through study completion, an average of 1 year2
compare the techniques used in terms of function and volumetric hypertrophy
Time frame
through study completion, an average of 1 year3
compare the techniques used in terms of drop-out
Time frame
through study completion, an average of 1 year4
compare the techniques used in terms of 90-day mortality
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov