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Can smarter surgical tools cut liver surgery risks?

NCT ID NCT07750275

Knowledge-focused Sponsor: University of Molise Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study looks back at the records of about 800 adults who had minimally invasive liver surgery (laparoscopic, robotic, or hybrid) at specialized Italian centers. The goal is to see how the choice of surgical tools and techniques for cutting liver tissue relates to the risk of serious bleeding or bile leaks after surgery. By comparing different approaches, researchers hope to identify which methods are safest and most cost-effective for various types of patients and procedures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this research could help surgeons choose safer and more cost-effective techniques for minimally invasive liver surgery, potentially reducing complications like bleeding and bile leaks.
What could go wrong
Because this is an observational registry, it can only show associations, not proof. Results may be influenced by differences between hospitals and surgeons, and the findings might not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.)

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Conditions

The condition(s) this trial relates to.

liver and intrahepatic bile duct neoplasm Liver Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Liver neoplasm Liver surgery Minimally invasive liver surgery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Molise

    Campobasso, CB, 86100, Italy

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