Parenchymal Sparing Hepatectomy in Post-chemotherapy Liver Atrophy

NCT ID: NCT06329700

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-01

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer Stage IV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Hepatectomy

Intervention Type PROCEDURE

Surgical removal of a part of the liver

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.

Hepatectomy

Intervention Type PROCEDURE

Surgical removal of a part of the liver

Interventions

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Hepatectomy

Surgical removal of a part of the liver

Intervention Type PROCEDURE

Other Intervention Names

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Liver resection

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero Universitaria Maggiore della Carita

OTHER

Sponsor Role lead

Responsible Party

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Matteo Donadon

Professor of Surgery, Head Surgical Oncology Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matteo Donadon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Eastern Piedmont

References

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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.

Reference Type RESULT
PMID: 28192187 (View on PubMed)

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.

Reference Type RESULT
PMID: 28585106 (View on PubMed)

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.

Reference Type RESULT
PMID: 19541011 (View on PubMed)

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.

Reference Type RESULT
PMID: 28083837 (View on PubMed)

Other Identifiers

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ParSparInLivAtrophy

Identifier Type: -

Identifier Source: org_study_id

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