Clinical trial NCT04257240: Recurrence of Liver Malignancy After Ischemia/Reperfusion Injury
Official title: Does Vascular Occlusion in Liver Resections Predispose to Recurrence of Malignancy in the Liver Remnant Due to Ischemia/Reperfusion Injury?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Reperfusion Injury
Liver Injury
Cancer Recurrence
Malignancy
Liver Cancer
Keywords: ischemia reperfusion injury
liver surgery
cancer recurrence
malignancy
hepatectomy
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: retrospective analysis of an internal hepatectomy database

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.

Detailed description: One hundred and eighteen patients were subjected to liver resection under total inflow and outflow vascular clamping and were assigned as study group. These individuals were retrospectively matched to 112 counterparts, who underwent liver surgery applying inflow and outflow vascular clamping only of the segment harboring the tumor, sparing the liver remnant from any I/R injury (control group). The two cohorts were compared regarding recurrence-free survival and overall survival.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* patients with extrahepatic disease
* patients with metastatic liver tumors

Primary outcomes:
measure: time to malignant recurrence
timeFrame: from time of operation until time of malignant recurrence, assessed up to 15 years
measure: time to death
timeFrame: from time of operation until time of death, assessed up to 20 years
Secondary outcomes:
measure: aspartate aminotrasferase (AST) levels
timeFrame: second postoperative day
Other outcomes:
Locations:
Study officials:
affiliation: Aretaieion University Hospital
name: Kassiani Theodoraki, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.