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
|
Patients underwent liver resection either by robotic or laparoscopic approach
|
|
Laparoscopic 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.
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.