Parenchymal Sparing Hepatectomy in Post-chemotherapy Liver Atrophy

Colorectal Cancer Stage IV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06329700
• Other study ID #: ParSparInLivAtrophy
• Status: Completed
• Start date: May 1, 2010
• Est. completion date: June 30, 2022

Study information

• Verified date: March 2024
• Source: Azienda Ospedaliero Universitaria Maggiore della Carita
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Colorectal Cancer Stage IV

Intervention

Procedure:
• Hepatectomy
Surgical removal of a part of the liver

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero Universitaria Maggiore della Carita

References & Publications (4)

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;2 — View 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 — View 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 app — View 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.j — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	Any adverse event after surgery	From the date of surgery up to 90 days