Outcome of Hepatocellular Carcinoma Patients With Portal Vein Thrombosis After Trans-Arterial Chemo Embolization

NCT05491889 | Unknown

• 1 other identifier: 17101837
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hepatocellular carcinoma (HCC) is the fifth most common neoplasm worldwide and the third most frequent cause of death from cancer in the world. Hepatocellular carcinoma is responsible for significant morbidity and mortality in cirrhosis. Most cases of HCC occur in the setting of cirrhosis and, therefore, prognosis is determined not only by factors related to the tumor but also by factors related to cirrhosis (1). According to previous reports, the incidence of HCC with partial portal vein thrombosis (PVTT) ranges between 44% and 62.2%. HCC associated with PVTT has a poor prognosis. It may lead to intrahepatic metastasis, liver dysfunction, and portal hypertension. The median overall survival for HCC patients with untreated PVTT is only 2.7 months (2). It was suggested that HCC with PVTT should be classified as stage C based on Barcelona Clinic Liver Cancer; it is no longer surgically treatable. Compared with conservative treatment, TACE is a safe and effective therapy for such cases. However, this modality for treatment might be associated with mortality (3). As far as we know, there is no studies of short-term survival in patients with HCC and PVT after TACE in our locality. Our study aims to determine frequency of short-term mortality (\< 3month) among HCC patients with PPVT after TACE, and to explore its predictors.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• mortality

  frequency of short term mortality

  3 months

Study Arms (1)

HCC patients with PPVT after TACE

determine frequency of short-term mortality (\< 3month) among HCC patients with PPVT after TACE, and to explore its predictors.

Biological: trans arterial chemoembolization

Interventions

trans arterial chemoembolization BIOLOGICAL

trans arterial chemoembolization in patient with partial portal vein thrombosis

HCC patients with PPVT after TACE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patient with hepatocellular carcinoma with partial portal vein thrombosis

You may qualify if:

• Age \> 18 years old
• HCC was diagnosed based on contrast imaging
• PPVT was diagnosed based on abdominal Duplex

You may not qualify if:

• Age \< 18 years old
• Complete PVT
• Any previous therapy for HCC
• Extrahepatic concomitant malignancy

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  PMID: 30207593 BACKGROUND

• Zhang ZM, Lai EC, Zhang C, Yu HW, Liu Z, Wan BJ, Liu LM, Tian ZH, Deng H, Sun QH, Chen XP. The strategies for treating primary hepatocellular carcinoma with portal vein tumor thrombus. Int J Surg. 2015 Aug;20:8-16. doi: 10.1016/j.ijsu.2015.05.009. Epub 2015 May 27.

  PMID: 26026424 BACKGROUND

• Xiang X, Lau WY, Wu ZY, Zhao C, Ma YL, Xiang BD, Zhu JY, Zhong JH, Li LQ. Transarterial chemoembolization versus best supportive care for patients with hepatocellular carcinoma with portal vein tumor thrombus：a multicenter study. Eur J Surg Oncol. 2019 Aug;45(8):1460-1467. doi: 10.1016/j.ejso.2019.03.042. Epub 2019 Apr 12.

  PMID: 31005471 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 8, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: February 1, 2025
• Last Updated: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share