Parenchymal Sparing Hepatectomy in Post-chemotherapy Liver Atrophy

NCT06329700 | Completed

• 1 other identifier: ParSparInLivAtrophy
• Study Type: observational
• Target: 74
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer Stage IV

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  Any adverse event after surgery

  From the date of surgery up to 90 days

Study Arms (2)

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

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

Interventions

Hepatectomy PROCEDURE

Surgical removal of a part of the liver

Also known as: Liver resection

No post-chemotherapy liver atrophy; Yes post-chemotherapy liver atrophy

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead

Related Publications (4)

• Yamashita S, Shindoh J, Mizuno T, Chun YS, Conrad C, Aloia TA, Vauthey JN. Hepatic atrophy following preoperative chemotherapy predicts hepatic insufficiency after resection of colorectal liver metastases. J Hepatol. 2017 Jul;67(1):56-64. doi: 10.1016/j.jhep.2017.01.031. Epub 2017 Feb 10.

  PMID: 28192187 RESULT

• Omichi K, Yamashita S, Cloyd JM, Shindoh J, Mizuno T, Chun YS, Conrad C, Aloia TA, Vauthey JN, Tzeng CD. Portal Vein Embolization Reduces Postoperative Hepatic Insufficiency Associated with Postchemotherapy Hepatic Atrophy. J Gastrointest Surg. 2018 Jan;22(1):60-67. doi: 10.1007/s11605-017-3467-1. Epub 2017 Jun 5.

  PMID: 28585106 RESULT

• Torzilli G, Procopio F, Botea F, Marconi M, Del Fabbro D, Donadon M, Palmisano A, Spinelli A, Montorsi M. One-stage ultrasonographically guided hepatectomy for multiple bilobar colorectal metastases: a feasible and effective alternative to the 2-stage approach. Surgery. 2009 Jul;146(1):60-71. doi: 10.1016/j.surg.2009.02.017.

  PMID: 19541011 RESULT

• Tani K, Shindoh J, Takamoto T, Shibahara J, Nishioka Y, Hashimoto T, Sakamoto Y, Hasegawa K, Makuuchi M, Kokudo N. Kinetic Changes in Liver Parenchyma After Preoperative Chemotherapy for Patients with Colorectal Liver Metastases. J Gastrointest Surg. 2017 May;21(5):813-821. doi: 10.1007/s11605-017-3359-4. Epub 2017 Jan 12.

  PMID: 28083837 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Matteo Donadon, MD, PhD

  University of Eastern Piedmont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, Head Surgical Oncology Program

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: May 1, 2010
• Primary Completion: December 31, 2019
• Study Completion: June 30, 2022
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After pubblication of the paper(s). No limit in time.
• Access Criteria: Reasonable request to the PI or corresponsing author.