Clinical trial NCT06329700: Parenchymal Sparing Hepatectomy in Post-chemotherapy Liver Atrophy
Official title: Performance of Parenchymal Sparing Hepatectomy in Patients With CLM and Post-chemotherapy Liver Atrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer Stage IV
Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by colorectal liver metastases awaiting liver surgery, and receiving before surgery systemic chemotherapy (neoadjuvant).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative complications
timeFrame: From the date of surgery up to 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Eastern Piedmont
name: Matteo Donadon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.