Robotic Versus Laparoscopic Liver Resection for Hepatocellular Carcinoma

NCT06496113 | Completed

• 1 other identifier: 2023-01022 CE 4377
• Study Type: observational
• Target: 196
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• Recurrence-free survival

  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

  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.

Study Arms (2)

Robotic liver resections

Procedure: Minimally invasive liver resection

Laparoscopic liver resection

Procedure: Minimally invasive liver resection

Interventions

Minimally invasive liver resection PROCEDURE

Patients underwent liver resection either by robotic or laparoscopic approach

Laparoscopic liver resection; Robotic liver resections

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 11, 2024
• Study Start: January 1, 2014
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07