Liver TumoursI-GROWtohNCT07445412
Italian Group of Regenerative and Occlusive Worldwide-used Techniques of Hepatic Hypertrophy
An observational study of Liver Tumours and Liver Cancer (Primary and Metastatic), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Tumours, Liver Cancer (Primary and Metastatic), Liver Resection
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 22 Oct 2024to Apr 2040
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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
Who may be able to join
- 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
Who cannot join
- pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitario di Bologna
Bologna, Bologna, 401328
Elio Jovine, MD, +39 3356468200, elio.jovine@aosp.bo.it
Matteo Serenari, MD, +39 3289277643, matteo.serenari@aosp.bo.it
About this study
Official title: Italian Group of Regenerative and Occlusive Worldwide-used Techniques of Hepatic Hypertrophy - IGROWtoh
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.
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort | The clinical information from prospectice cohort will be collected from the moment of recruitment , as far as possible, for up to 5 years after surgery in order to record any events that occur in a timely manner. | |
| Retrospective Cohort | There is also a plan to 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the temporal trends in the use of techniques for inducing hepatic hypertrophy in Italy
Measured: through study completion, an average of 1 year
compare the techniques used in terms of function and volumetric hypertrophy
Measured: through study completion, an average of 1 year
compare the techniques used in terms of drop-out
Measured: through study completion, an average of 1 year
compare the techniques used in terms of 90-day mortality
Measured: through study completion, an average of 1 year
compare the techniques used in terms of long-term survival
Measured: through study completion, an average of 1 year
compare the techniques used in terms of disease-free survival
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start22 Oct 2024
- Primary completionOct 2039 (estimated)
- Study completionApr 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TumoursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elio Jovine, MD, Principal investigator, IRCCS Policlinico di Sant'Orsola - Malpighi (Bologna, Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445412
- Sponsor's protocol ID
- I-GROWtoh
- Acronym
- I-GROWtoh
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Group of Regenerative and Occlusive Worldwide-used Techniques of Hepatic Hypertrophy - IGROWtoh
- ClinicalTrials.gov ID
- NCT07445412
- Acronym / sponsor ID
- I-GROWtoh / I-GROWtoh
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- Oct 2039 (estimated)
- Study completion
- Apr 2040 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | – | –The clinical information from prospectice cohort will be collected from the moment of recruitment , as far as possible, for up to 5 years after surgery in order to record any events that occur in a timely manner. |
| Retrospective Cohort | – | –There is also a plan to 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elio Jovine, MD principal investigator
IRCCS Policlinico di Sant'Orsola - Malpighi (Bologna, Italy)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Tumours and Liver Cancer (Primary and Metastatic), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elio Jovine, MD (+39 3356468200, elio.jovine@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.