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NCT05036265 Clinical Trial

Prognostic Factors and Oncological Outcomes in Laparoscopic Liver Resection for CRLM

Colorectal Cancer Clinical Trial

Official title:
Laparoscopic Liver Resection for Colorectal Liver Metastases: Retrospective Analysis of Prognostic Factors and Oncological Outcomes in a Single-center Cohort

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05036265
Other study ID # B396201939301
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2011
Est. completion date August 5, 2021

Study information
Verified date August 2021
Source General Hospital Groeninge
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Laparoscopic liver resection (LLR) has gained acceptance as an effective treatment for colorectal liver metastases (CRLM) in selected patients, providing similar oncologic outcomes compared to open liver resection (OLR). A single-center retrospective analysis of a prospectively maintained database was performed. The primary aim of this study was to determine prognostic factors for the survival outcomes associated with LLR for CRLM.

Description:

LLR was defined as pure LLR, including conversions to OLR. In case of missing data, additional details were retrieved from the individual patient file. Data on patient demographics, timing of diagnosis, neoadjuvant chemotherapy (NAC), tumor characteristics (both primary tumor and CRLM), histopathology, molecular characteristics, operative technique (including classification into anatomically major/technically major/minor LR), intra- and postoperative course, adjuvant chemotherapy (AC) as well as oncological outcomes (OS and DFS) were gathered and analyzed. Postoperative complications were graded according to the Clavien-Dindo classification. Complications were classified as major in case of Clavien-Dindo ≥ 3A.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date August 5, 2021
Est. primary completion date March 15, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients diagnosed with colorectal liver metastases - Patients who received laparoscopic liver resection for colorectal liver metastases - Patients who received the laparoscopic liver resection between September 2011 and mid-March 2020 Exclusion Criteria: - Patients with contraindication for laparoscopic liver resection - Refusal to participate in the study

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
General Hospital Groeninge

Outcome
Type Measure Description Time frame Safety issue
Primary Survival outcomes Overall and disease-free survival (Kaplan-Meier method) 9 years
Primary Prognostic factors Univariate Cox proportional-hazards regression analysis 9 years
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