Robotic Versus Laparoscopic Liver Resection for Hepatocellular Carcinoma

July 8, 2024 updated by: Ente Ospedaliero Cantonale, Bellinzona

Recurrence ad Survival After Robotic Versus Laparoscopic Liver Resection in Very-early to Early (BCLC 0-A) Hepatocellular Carcinoma

The objective of the study is to investigate the long-term outcomes of minimally invasive liver surgery (robotic vs laparoscopic) for hepatocellular carcinoma patients of stage BCLC 0-A. Data from two tertiary centers for liver surgery will be retrospectively reviewed. Patients will be divided in two cohorts (robot; laparoscopy). The primary endpoint will be recurrence-free and overall survival; secondary endpoints were incidence, pattern, and treatment of recurrences.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

196

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients underwent minimally invasive liver resection in centers participating in the study

Description

Inclusion Criteria:

  • Patients undergoing robotic and laparoscopic resections
  • Histology-confirmed HCC of stage BCLC 0-A
  • Preserved liver function (Child score A-B)
  • Patients >18 years old

Exclusion Criteria:

  • Hand-assisted procedures
  • Non-elective surgery
  • Intraoperative switch to locoregional therapies (like radiofrequency or microwave ablation)
  • Non-histologically confirmed HCC
  • Mixed hepato-cholangiocarcinoma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Robotic liver resections
Procedure: Minimally invasive liver resection
Patients underwent liver resection either by robotic or laparoscopic approach
Laparoscopic liver resection
Procedure: Minimally invasive liver resection
Patients underwent liver resection either by robotic or laparoscopic approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival
Time Frame: From the date of liver resection until the first documented HCC progression on follow-up imaging, assessed up to 116 months. The Minimum follow-up accepted was of 3 months postoperatively.
Recurrence was dated at the first HCC detection on follow-up imaging.
From the date of liver resection until the first documented HCC progression on follow-up imaging, assessed up to 116 months. The Minimum follow-up accepted was of 3 months postoperatively.
Overall survival
Time Frame: From the date of liver resection until the date of death for any cause or the last follow-up available whichever came first, assessed up to 116 months. The Minimum follow-up accepted was of 3 months postoperatively.
From the date of liver resection until the date of death for any cause or the last follow-up available whichever came first, assessed up to 116 months. The Minimum follow-up accepted was of 3 months postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ente Ospedaliero Cantonale, Bellinzona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

July 1, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Actual)

July 11, 2024

Last Update Submitted That Met QC Criteria

July 8, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-01022 CE 4377

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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