Liver SurgeryLIVER-MIND 2NCT07750275
Safety and Economics of Parenchymal Transection in Minimally Invasive Liver Surgery
An observational study of Liver Surgery and MINIMALLY INVASIVE LIVER SURGERY, run by University of Molise at 1 site in Italy.
Trial summary
LIVER-MIND 2 is a multicentre, observational, retrospective registry coordinated by the SICE HPB and Minimally Invasive Surgery Working Group, enrolling consecutive adults undergoing elective minimally invasive (laparoscopic, robotic or hybrid) liver resection between January 2021 and December 2025 across ≥15… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Surgery, MINIMALLY INVASIVE LIVER SURGERY, Liver Neoplasm
- How many people
- 800 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to Dec 2027
- 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: Participation is open to centres with an annual MILS volume ≥20 cases/year, or >10 cases/year if operating as a dedicated HPB unit. A minimum of 15 centres is required, with a target of more than 30 centres distributed across the three Italian macro-areas (North, Centre, South), with possible international participation. Each centre completes a standardised electronic case report form (e-CRF) and contributes consecutive eligible cases. Table 1 shows elegibility criteria. Consecutive eligible procedures performed between January 2021 and December 2025 are included. To control for the robotic HPB learning curve, the first 65 robotic cases of each centre are excluded, consistent with the published learning-curve evidence. This safeguards the robotic and hybrid comparisons against early-experience confounding.
Who may be able to join
- Age ≥ 18 years
- Elective minimally invasive liver resection
- Laparoscopic, robotic or hybrid approach
- Benign or malignant disease
- Signed informed consent for use of anonymised data
- Data completeness ≥ 70% in the CRF
Who cannot join
- Urgent or emergency surgery
- Liver transplantation (donor / recipient)
- Associated major non-hepatic biliary or vascular resection
- Lack of consent or follow-up
- Participation in conflicting interventional trials
- Surgery before January 2021
- Robotic procedures performed during the learning-curve phase (first 65 robotic cases per centre, per Rahimli et al.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Economics of Parenchymal Transection in Minimally Invasive Liver Surgery (LIVER-MIND 2): a Multicentre Retrospective Registry of the Italian Society of Endoscopic Surgery (SICE)
LIVER-MIND 2 is a multicentre, observational, retrospective registry coordinated by the SICE HPB and Minimally Invasive Surgery Working Group, enrolling consecutive adults undergoing elective minimally invasive (laparoscopic, robotic or hybrid) liver resection between January 2021 and December 2025 across ≥15 high-volume or dedicated centres (target >30 centres).
Read the detailed description
LIVER-MIND 2 is a multicentre, observational, retrospective registry coordinated by the SICE HPB and Minimally Invasive Surgery Working Group, enrolling consecutive adults undergoing elective minimally invasive (laparoscopic, robotic or hybrid) liver resection between January 2021 and December 2025 across ≥15 high-volume or dedicated centres (target >30 centres). The first 65 robotic cases per centre are excluded to account for the robotic HPB learning curve. The primary exposure is the transection strategy/primary device, with the principal contrast between cavitron ultrasonic surgical aspirator (CUSA) and energy devices. The primary outcome is a 90-day composite transection-related complication: significant bleeding (estimated blood loss >500 mL and/or transfusion and/or reintervention for haemostasis) and/or clinically relevant bile leak (ISGLS grade B-C). Secondary outcomes include conversion, Clavien-Dindo ≥IIIa morbidity, post-hepatectomy liver failure (PHLF), operative time, length of stay, 90-day readmission and mortality, oncological radicality, and direct costs. The target sample size is ≈900 patients (80% power, two-sided α = 0.05, expected composite event rate 12%, minimal clinically relevant difference 5%, 5% drop-out inflation). The primary analysis uses multivariable logistic regression with propensity-score matching and inverse-probability-of-treatment weighting; pre-specified subgroup analyses and a statistical analysis plan are deposited before database lock. An exploratory cost analysis adopts a hospital perspective combining DRG-based standard costing and device-level micro-costing.
- Keywords
- LIVER TRANSECTION DEVICES
- Medical subject headings
- Liver Neoplasms
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 |
|---|---|---|
| Patients underwent minimally invasive liver transection | Comparison among liver transection devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Rate of bleeding according to Post-Hepatectomy Haemorrhage (PHH) by International Study Group of Liver Surgery (ISGLS) 2. Rate of bile leak according to ISGLS classification in patients with abdominal drainage and/or undergoing percutaneous drainage
Our retrospective study aims to assess the association between the adopted parenchymal transection strategy and devices and the incidence of the composite transection-related complication. The analysis will be conduct among pre-specified subgroup: Minor (<3 segments) vs Major (≥3 segments) vs Complex (segments I, IVa, VII, VIII) stratified by IWATE score (low 0-3, intermediate 4-6, advanced 7-10); Cirrhosis (Child-Pugh A vs B) vs steatosis (grade I-II vs III/NASH) vs healthy parenchyma; High volume (>50 MILS/year) vs low volume but dedicated (10-50 MILS/year); robotic vs. laparoscopic vs. hybrid approach; Malignant (primary vs secondary) vs benign disease
The main 90-day postoperative outcomes are:
- rate of significant bleeding according to Post-Hepatectomy Haemorrhage (PHH) by International Study Group of Liver Surgery (ISGLS);
- rate of bile leak according to ISGLS classification;
Measured: January 2021 to December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Jan 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver SurgeryStudies 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
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Molise
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pasquale Avella, University of Molise
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750275
- Sponsor's protocol ID
- 29501
- Acronym
- LIVER-MIND 2
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ceccarelli G, Avella P, Muttillo EM, Conticchio M, Tebala GD, Piccolo G, Romano L, Memeo R, Rocca A; LIVER-MIND (Minimally Invasive Surgery and pareNchyma transection Devices) Study Group. Devices for minimally invasive liver parenchyma transection: the SICE (Italian Society of Endoscopic Surgery) Italian and International survey. Surg Endosc. 2025 Aug;39(8):4822-4838. doi: 10.1007/s00464-025-11769-3. Epub 2025 Jun 16.
PubMed 40523976
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Economics of Parenchymal Transection in Minimally Invasive Liver Surgery (LIVER-MIND 2): a Multicentre Retrospective Registry of the Italian Society of Endoscopic Surgery (SICE)
- ClinicalTrials.gov ID
- NCT07750275
- Acronym / sponsor ID
- LIVER-MIND 2 / 29501
- Keywords
- LIVER TRANSECTION DEVICES
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of MoliseUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Aug 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.
LIVER-MIND 2 is a multicentre, observational, retrospective registry coordinated by the SICE HPB and Minimally Invasive Surgery Working Group, enrolling consecutive adults undergoing elective minimally invasive (laparoscopic, robotic or hybrid) liver resection between January 2021 and December 2025 across ≥15 high-volume or dedicated centres (target >30 centres).
Detailed description
LIVER-MIND 2 is a multicentre, observational, retrospective registry coordinated by the SICE HPB and Minimally Invasive Surgery Working Group, enrolling consecutive adults undergoing elective minimally invasive (laparoscopic, robotic or hybrid) liver resection between January 2021 and December 2025 across ≥15 high-volume or dedicated centres (target >30 centres). The first 65 robotic cases per centre are excluded to account for the robotic HPB learning curve. The primary exposure is the transection strategy/primary device, with the principal contrast between cavitron ultrasonic surgical aspirator (CUSA) and energy devices. The primary outcome is a 90-day composite transection-related complication: significant bleeding (estimated blood loss >500 mL and/or transfusion and/or reintervention for haemostasis) and/or clinically relevant bile leak (ISGLS grade B-C). Secondary outcomes include conversion, Clavien-Dindo ≥IIIa morbidity, post-hepatectomy liver failure (PHLF), operative time, length of stay, 90-day readmission and mortality, oncological radicality, and direct costs. The target sample size is ≈900 patients (80% power, two-sided α = 0.05, expected composite event rate 12%, minimal clinically relevant difference 5%, 5% drop-out inflation). The primary analysis uses multivariable logistic regression with propensity-score matching and inverse-probability-of-treatment weighting; pre-specified subgroup analyses and a statistical analysis plan are deposited before database lock. An exploratory cost analysis adopts a hospital perspective combining DRG-based standard costing and device-level micro-costing.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients underwent minimally invasive liver transection | – | –Comparison among liver transection devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participation is open to centres with an annual MILS volume ≥20 cases/year, or >10 cases/year if operating as a dedicated HPB unit. A minimum of 15 centres is required, with a target of more than 30 centres distributed across the three Italian macro-areas (North, Centre, South), with possible international participation. Each centre completes a standardised electronic case report form (e-CRF) and contributes consecutive eligible cases. Table 1 shows elegibility criteria. Consecutive eligible procedures performed between January 2021 and December 2025 are included. To control for the robotic HPB learning curve, the first 65 robotic cases of each centre are excluded, consistent with the published learning-curve evidence. This safeguards the robotic and hybrid comparisons against early-experience confounding.
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Elective minimally invasive liver resection
- Laparoscopic, robotic or hybrid approach
- Benign or malignant disease
- Signed informed consent for use of anonymised data
Key exclusion criteria (7 listed)
- Urgent or emergency surgery
- Liver transplantation (donor / recipient)
- Associated major non-hepatic biliary or vascular resection
- Lack of consent or follow-up
- Participation in conflicting interventional trials
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
1. Rate of bleeding according to Post-Hepatectomy Haemorrhage (PHH) by International Study Group of Liver Surgery (ISGLS) 2. Rate of bile leak according to ISGLS classification in patients with abdominal drainage and/or undergoing percutaneous drainage
Time frame: January 2021 to December 2025
Our retrospective study aims to assess the association between the adopted parenchymal transection strategy and devices and the incidence of the composite transection-related complication. The analysis will be conduct among pre-specified subgroup: Minor (<3 segments) vs Major (≥3 segments) vs Complex (segments I, IVa, VII, VIII) stratified by IWATE score (low 0-3, intermediate 4-6, advanced 7-10); Cirrhosis (Child-Pugh A vs B) vs steatosis (grade I-II vs III/NASH) vs healthy parenchyma; High volume (>50 MILS/year) vs low volume but dedicated (10-50 MILS/year); robotic vs. laparoscopic vs. hybrid approach; Malignant (primary vs secondary) vs benign disease The main 90-day postoperative outcomes are: 1. rate of significant bleeding according to Post-Hepatectomy Haemorrhage (PHH) by International Study Group of Liver Surgery (ISGLS); 2. rate of bile leak according to ISGLS classification;
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 6 Aug 2026.
- Results publication: PubMed 40523976Ceccarelli G, Avella P, Muttillo EM, Conticchio M, Tebala GD, Piccolo G, Romano L, Memeo R, Rocca A; LIVER-MIND (Minimally Invasive Surgery and pareNchyma transection Devices) Study Group. Devices for minimally invasive liver parenchyma transection: the SICE (Italian Society of Endoscopic Surgery) Italian and International survey. Surg Endosc. 2025 Aug;39(8):4822-4838. doi: 10.1007/s00464-025-11769-3. Epub 2025 Jun 16.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Surgery and MINIMALLY INVASIVE LIVER SURGERY, run by University of Molise 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 6 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 6 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Rate of bleeding according to Post-Hepatectomy Haemorrhage (PHH) by International Study Group of Liver Surgery (ISGLS) 2. Rate of bile leak according to ISGLS classification in patients with abdominal drainage and/or undergoing percutaneous drainage (time frame: January 2021 to December 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07750275, which also lists 1 linked publication.
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 6 Aug 2026.