Parenchymal Sparing Hepatectomy in Post-chemotherapy Liver Atrophy

Completed

• Conditions: Colorectal Cancer Stage IV
• Interventions: Procedure: Hepatectomy

• Registration Number: NCT06329700
• Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

Brief Summary

Major hepatectomy in patients with colorectal liver metastases (CLM) and post-chemotherapy liver atrophy is associated with increased complications. Whether the performance of parenchymal-sparing hepatectomy (PSH) in those patients can be safer is unknown. The aim of this study was to assess the clinical impact of post-chemotherapy liver atrophy on patients undergoing PSH for CLM. For this purpose, the occurrence of liver atrophy was recorded and then computed against the occurrence of postoperative morbidity and mortality.

Detailed Description

Patients affected by CLMs and trated with neoadjuvant systemic chemotherapy and then hepatectomy were reviewed with the intent to assess the occurrence of liver atrophy, which is a sign of liver dysfunction and a source of morbidity expecially in patients treated with major or extended hepatectomy. Whether the performance of parenchymal-sparing hepatectomy (PSH) in those patients can be safer is unknown. Then, we planned to review our cases with the above mentioned endpoint.

Study Timeline

• Study Start: 2010-05-01
• Primary Completion: 2019-12-31
• Study Completion: 2022-06-30
• Status Verified: 2024-03
• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-03-19
• Last Update Submitted: 2024-03-19
• Study First Posted: 2024-03-26
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Consecutive patients with multiple CLMs treated with preoperative chemotherapy and parenchymal sparing surgery;
• Only patients with available volumetry of the pre- and post-chemotherapy abdominal enhanced computed tomography (CT) images;

Exclusion Criteria

• Patients who underwent preoperative PVE;
• Patients treated by major hepatectomies; Patients treated with thermal ablation alone or in association with hepatic resection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No post-chemotherapy liver atrophy	Hepatectomy	Patients treated with systemic chemotherapy, then hepatectomy for colorectal liver metastases. No occurrence of post-chemotherapy liver atrophy as measured by computed-tomography liver volumetry.
Yes post-chemotherapy liver atrophy	Hepatectomy	Patients treated with systemic chemotherapy, then hepatectomy for colorectal liver metastases. Yes, occurrence of post-chemotherapy liver atrophy as measured by computed-tomography liver volumetry.

Primary Outcome Measures

Name	Time	Method
Postoperative complications	From the date of surgery up to 90 days	Any adverse event after surgery