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Portal Hypertension and Liver Resection in Patients With Hepatocellular Carcinoma

Assessment and Impact of Portal Hypertension Before and During Liver Resection in Patients With Hepatocellular Carcinoma

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02145013
Enrollment
200
Registered
2014-05-22
Start date
2013-11-30
Completion date
2018-05-30
Last updated
2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Liver Cancers

Keywords

portal hypertension, hepatocellular carcinoma, resection

Brief summary

According to the BCLC guidelines, surgical resection of hepatocellular carcinoma complicating cirrhosis is restricted to patients with preserved liver function, single nodule without vascular invasion and with hepatic venous gradient below 10 mmHg. However, other guideline treatment, especially from eastern countries demonstrated that surgical resection is safe and feasible and provides better survival than the treatment recommended by the BCLC system for patients with similar stage. The primary goal of this study is to assess the impact of HVPG on short and long-term outcomes in HCC patients who undergo liver resection.

Detailed description

Patients with HCC and candidates for hepatectomy are classified into two groups according to the presence of portal hypertension. Short- and long-term outcomes will be compared.

Interventions

PROCEDURELiver resection

Hepatectomy by either open, laparoscopic or robotic procedures

Sponsors

Henri Mondor University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Patients with hepatocellular carcinoma who undergo surgical resection (intention to treat analysis)

Design outcomes

Primary

MeasureTime frameDescription
Mortality90 dayIn-hospital or 90-day mortality

Secondary

MeasureTime frameDescription
morbidity90 dayOverall and liver-related complications including liver failure, ascites, biliary fistula, bleeding, pulmonary complications, and renal complications. Grading system according to Clavien-Dindo classification
Survival outcomes1,3 and 5 yearsIncluding Overall survival and disease free survival

Other

MeasureTime frameDescription
Acute kidney injurywithin 90 days after surgeryAs defined by the KDIGIO criteria
Impact of PET CT on overall survival following liver resectionBefore liver resectionquantitative assessment of metabolic uptake (FDG and choline)
SarcopeniaBefore liver resectionusing computed tomography
Time from diagnosis to liver resectionfrom the date of diagnosis until the date of first referral and from the date of first referral to date of hepatectomy, assessed up to 3 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026