NCT04257240

Brief Summary

Severe ischemic changes of the liver remnant after hepatectomy could expedite tumor recurrence on the residual liver. Our study aimed at assessing the effect of warm ischemic/reperfusion (I/R) injuries on surgery-to-local recurrence interval and patient overall survival, during major hepatectomies under inflow and outflow vascular control.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2012

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

13 years

First QC Date

February 2, 2020

Last Update Submit

February 4, 2020

Conditions

Ischemic Reperfusion InjuryLiver InjuryCancer RecurrenceMalignancyLiver Cancer

Keywords

ischemia reperfusion injuryliver surgerycancer recurrencemalignancyhepatectomy

Outcome Measures

Primary Outcomes (2)

  • time to malignant recurrence

    recurrence-free survival

    from time of operation until time of malignant recurrence, assessed up to 15 years

  • time to death

    overall survival

    from time of operation until time of death, assessed up to 20 years

Secondary Outcomes (1)

  • aspartate aminotrasferase (AST) levels

    second postoperative day

Study Arms (2)

study group

patients subjected to major hepatectomy with vascular control of blood inflow and outflow of the whole liver

Procedure: selective hepatic vascular exclusion

control group

patients subjected to major hepatectomy by selectively clamping the portal and hepatic vessels only of the lobe harboring the tumor

Procedure: semielective hepatic vascular exclusion

Interventions

selective hepatic vascular exclusionPROCEDURE

major hepatectomy with vascular control of blood inflow and outflow of the whole liver

study group
semielective hepatic vascular exclusionPROCEDURE

major liver resection by selectively clamping the portal and hepatic vessels only of the lobe harboring the tumor

control group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

retrospective analysis of an internal hepatectomy database

You may qualify if:

  • Adult patients
  • American Society of Anesthesiologists (ASA) distribution I to III
  • Patients scheduled for major liver resection (≥3 segments)

You may not qualify if:

  • patients with extrahepatic disease
  • patients with metastatic liver tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Smyrniotis V, Farantos C, Kostopanagiotou G, Arkadopoulos N. Vascular control during hepatectomy: review of methods and results. World J Surg. 2005 Nov;29(11):1384-96. doi: 10.1007/s00268-005-0025-x.

    PMID: 16222453BACKGROUND

  • Smyrniotis VE, Kostopanagiotou GG, Contis JC, Farantos CI, Voros DC, Kannas DC, Koskinas JS. Selective hepatic vascular exclusion versus Pringle maneuver in major liver resections: prospective study. World J Surg. 2003 Jul;27(7):765-9. doi: 10.1007/s00268-003-6978-8.

    PMID: 14509502BACKGROUND

  • Huang J, Tang W, Hernandez-Alejandro R, Bertens KA, Wu H, Liao M, Li J, Zeng Y. Intermittent hepatic inflow occlusion during partial hepatectomy for hepatocellular carcinoma does not shorten overall survival or increase the likelihood of tumor recurrence. Medicine (Baltimore). 2014 Dec;93(28):e288. doi: 10.1097/MD.0000000000000288.

    PMID: 25526466BACKGROUND

  • Liu L, Ren ZG, Shen Y, Zhu XD, Zhang W, Xiong W, Qin Y, Tang ZY. Influence of hepatic artery occlusion on tumor growth and metastatic potential in a human orthotopic hepatoma nude mouse model: relevance of epithelial-mesenchymal transition. Cancer Sci. 2010 Jan;101(1):120-8. doi: 10.1111/j.1349-7006.2009.01363.x. Epub 2009 Sep 14.

    PMID: 19832842BACKGROUND

  • Serracino-Inglott F, Habib NA, Mathie RT. Hepatic ischemia-reperfusion injury. Am J Surg. 2001 Feb;181(2):160-6. doi: 10.1016/s0002-9610(00)00573-0.

    PMID: 11425059BACKGROUND

  • Man K, Ng KT, Lo CM, Ho JW, Sun BS, Sun CK, Lee TK, Poon RT, Fan ST. Ischemia-reperfusion of small liver remnant promotes liver tumor growth and metastases--activation of cell invasion and migration pathways. Liver Transpl. 2007 Dec;13(12):1669-77. doi: 10.1002/lt.21193.

    PMID: 18044786BACKGROUND

  • Ozaki M, Todo S. Surgical stress and tumor behavior: impact of ischemia-reperfusion and hepatic resection on tumor progression. Liver Transpl. 2007 Dec;13(12):1623-6. doi: 10.1002/lt.21230. No abstract available.

    PMID: 18044752BACKGROUND

  • Cho JY, Han HS, Choi Y, Yoon YS, Kim S, Choi JK, Jang JS, Kwon SU, Kim H. Association of Remnant Liver Ischemia With Early Recurrence and Poor Survival After Liver Resection in Patients With Hepatocellular Carcinoma. JAMA Surg. 2017 Apr 1;152(4):386-392. doi: 10.1001/jamasurg.2016.5040.

    PMID: 28052154BACKGROUND

  • Portolani N, Coniglio A, Ghidoni S, Giovanelli M, Benetti A, Tiberio GA, Giulini SM. Early and late recurrence after liver resection for hepatocellular carcinoma: prognostic and therapeutic implications. Ann Surg. 2006 Feb;243(2):229-35. doi: 10.1097/01.sla.0000197706.21803.a1.

    PMID: 16432356BACKGROUND

  • Theodoraki K, Papadoliopoulou M, Petropoulou Z, Theodosopoulos T, Vassiliu P, Polydorou A, Xanthakos P, Fragulidis G, Smyrniotis V, Arkadopoulos N. Does vascular occlusion in liver resections predispose to recurrence of malignancy in the liver remnant due to ischemia/reperfusion injury? A comparative retrospective cohort study. Int J Surg. 2020 Aug;80:68-73. doi: 10.1016/j.ijsu.2020.06.019. Epub 2020 Jun 30.

    PMID: 32619621DERIVED

MeSH Terms

Conditions

NeoplasmsLiver NeoplasmsReperfusion Injury

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kassiani Theodoraki, PhD

    Aretaieion University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology

Study Record Dates

First Submitted

February 2, 2020

First Posted

February 5, 2020

Study Start

January 1, 2000

Primary Completion

December 31, 2012

Study Completion

December 31, 2012

Last Updated

February 5, 2020

Record last verified: 2020-02