Chemotherapy and Tumor Clearance in Hepatic Resections for Colorectal Liver Metastases.

Effect of Chemotherapy and Tumor Clearance in Hepatic Resections for Colorectal Liver Metastases. A Single-centre Cohort Study

Retrospective analysis of a prospectively collected database of 170 patients between 2004 and 2020, who underwent liver resections for CRLM (colorectal liver metastases) at The Queen Elizabeth Hospital trying to determine rates and patterns of recurrence following liver resections for CRLM and concurrently, characterise clinical, pathological and treatment-related factors that could function as predictors of recurrence or survival, particularly neoadjuvant chemotherapy and tumour clearance.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer Metastatic; Liver Metastases
• Intervention / Treatment: Procedure: Hepatectomy

Detailed Description

This is a descriptive, observational study with retrospective analysis of a prospectively collated database. This database included all patients who underwent curative hepatic resections for CRLM (colorectal liver metastases) at The Queen Elizabeth Hospital (Adelaide, Australia) between December 2004 and October 2020.

• Study Type: Observational
• Enrollment (Actual): 170

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Australian citizens (most of them locals) treated at The Queen Elizabeth Hospital, Adelaide, SA.

Description

Inclusion Criteria:

• Patients who underwent a liver resection for CRLM at The Queen Elizabeth Hospital between December 2004 to September 2020

Exclusion Criteria:

• Patients whose procedures were abandoned due to unresectable tumour burden

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence	Recurrence rate	From surgery to recurrence, up to 16 years
Survival	up to16 years	From surgery to death or end of the study, up to 16 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resection margins	Resection margins of the liver resection	From surgery to death or end of the study, up to 16 years
Neoadjuvant Chemotherapy	Neoadjuvant Chemotherapy (yes or not)	From surgery to death or end of the study, up to 16 years

Collaborators and Investigators

• Sponsor: Hospital Maciel
• Collaborators: University of Adelaide
• Investigators: Principal Investigator: Mauro A Perdomo, MD, MHA, Assitant Professor at Clinica Quirurgica 3. Universidad de la Republica. Monteviedo, Uruguay

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2004
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: March 5, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 5, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neoplastic Processes; Neoplasm Metastasis; Liver Neoplasms
• Other Study ID Numbers: CRLM1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data could be provided on reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No