Parenchymal Sparing Hepatectomy in Post-chemotherapy Liver Atrophy

March 19, 2024 updated by: Matteo Donadon, Azienda Ospedaliero Universitaria Maggiore della Carita

Performance of Parenchymal Sparing Hepatectomy in Patients With CLM and Post-chemotherapy Liver Atrophy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

74

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients affected by colorectal liver metastases awaiting liver surgery, and receiving before surgery systemic chemotherapy (neoadjuvant).

Description

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 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
No post-chemotherapy liver atrophy
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.
Procedure: Hepatectomy
Surgical removal of a part of the liver
Other Names:
  • Liver resection
Yes post-chemotherapy liver atrophy
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.
Procedure: Hepatectomy
Surgical removal of a part of the liver
Other Names:
  • Liver resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: From the date of surgery up to 90 days
Any adverse event after surgery
From the date of surgery up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Investigators

  • Principal Investigator: Matteo Donadon, MD, PhD, University of Eastern Piedmont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 1, 2010

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ParSparInLivAtrophy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Yes, after reasonable request.

IPD Sharing Time Frame

After pubblication of the paper(s). No limit in time.

IPD Sharing Access Criteria

Reasonable request to the PI or corresponsing author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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.

Subscribe