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

NCT07445412 | Recruiting

• 1 other identifier: I-GROWtoh
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• Describe the temporal trends in the use of techniques for inducing hepatic hypertrophy in Italy

  through study completion, an average of 1 year

• compare the techniques used in terms of function and volumetric hypertrophy

  through study completion, an average of 1 year

• compare the techniques used in terms of drop-out

  through study completion, an average of 1 year

• compare the techniques used in terms of 90-day mortality

  through study completion, an average of 1 year

• compare the techniques used in terms of long-term survival

  through study completion, an average of 1 year

• compare the techniques used in terms of disease-free survival

  through study completion, an average of 1 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• pregnant or breastfeeding woman

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitario di Bologna

Bologna, Bologna, 401328, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elio Jovine, MD

  IRCCS Policlinico di Sant'Orsola - Malpighi (Bologna, Italy)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elio Jovine, MD

CONTACT

+39 3356468200; elio.jovine@aosp.bo.it

Matteo Serenari, MD

CONTACT

+39 3289277643; matteo.serenari@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: March 3, 2026
• Study Start: October 22, 2024
• Primary Completion (Estimated): October 1, 2039
• Study Completion (Estimated): April 1, 2040
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

IT (1)