Recurrence of Liver Malignancy After Ischemia/Reperfusion Injury

Liver Cancer Clinical Trial

— annie-liver  

Official title:

Does Vascular Occlusion in Liver Resections Predispose to Recurrence of Malignancy in the Liver Remnant Due to Ischemia/Reperfusion Injury?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04257240
• Other study ID #: liver IR
• Status: Completed
• Start date: January 1, 2000
• Est. completion date: December 31, 2012

Study information

• Verified date: February 2020
• Source: Aretaieion University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: December 31, 2012
• Est. primary completion date: December 31, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer Recurrence
• Ischemia
• Ischemic Reperfusion Injury
• Liver Cancer
• Liver Injury
• Malignancy
• Neoplasms
• Recurrence
• Reperfusion Injury
• Wounds and Injuries

Intervention

Procedure:
• selective hepatic vascular exclusion
major hepatectomy with vascular control of blood inflow and outflow of the whole liver
• semielective hepatic vascular exclusion
major liver resection by selectively clamping the portal and hepatic vessels only of the lobe harboring the tumor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aretaieion University Hospital

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View 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. — View Citation

Serracino-Inglott F, Habib NA, Mathie RT. Hepatic ischemia-reperfusion injury. Am J Surg. 2001 Feb;181(2):160-6. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to malignant recurrence	recurrence-free survival	from time of operation until time of malignant recurrence, assessed up to 15 years
Primary	time to death	overall survival	from time of operation until time of death, assessed up to 20 years
Secondary	aspartate aminotrasferase (AST) levels	aspartate aminotransferase levels	second postoperative day