Italian Group of Regenerative and Occlusive Worldwide-used Techniques of Hepatic Hypertrophy (I-GROWtoh)

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Resection; Liver Hypertrophy; Liver Tumours; Liver Cancer (Primary and Metastatic)

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Elio Jovine, MD; Phone Number: +39 3356468200; Email: elio.jovine@aosp.bo.it
• Study Contact Backup: Name: Matteo Serenari, MD; Phone Number: +39 3289277643; Email: matteo.serenari@aosp.bo.it

Study Locations

• Italy
  • Bologna
    • Bologna, Bologna, Italy, 401328
      • Recruiting
      • IRCCS Azienda Ospedaliero-Universitario di Bologna
      • Contact: Elio Jovine, MD; Phone Number: +39 3356468200; Email: elio.jovine@aosp.bo.it
      • Contact: Matteo Serenari, MD; Phone Number: +39 3289277643; Email: matteo.serenari@aosp.bo.it
      • Principal Investigator: Elio Jovine, MD
      • Sub-Investigator: Matteo Serenari, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Elio Jovine, MD, IRCCS Policlinico di Sant'Orsola - Malpighi (Bologna, Italy)

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Estimated): October 1, 2039
• Study Completion (Estimated): April 1, 2040

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Neoplastic Processes; Carcinoma; Pathological Conditions, Signs and Symptoms; Carcinoma, Hepatocellular; Neoplasm Metastasis; Liver Neoplasms
• Other Study ID Numbers: I-GROWtoh

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No