Clinical trial NCT02145013: Portal Hypertension and Liver Resection in Patients With Hepatocellular Carcinoma
Official title: Assessment and Impact of Portal Hypertension Before and During Liver Resection in Patients With Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Liver Cancers
Keywords: portal hypertension, hepatocellular carcinoma, resection
Lead sponsor: Henri Mondor University Hospital
Sponsor class: OTHER
First posted: 2014-05-22
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with hepatocellular carcinoma

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.

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

Primary outcomes:
measure: Mortality
timeFrame: 90 day
Secondary outcomes:
measure: morbidity
timeFrame: 90 day
measure: Survival outcomes
timeFrame: 1,3 and 5 years
Other outcomes:
measure: Acute kidney injury
timeFrame: within 90 days after surgery
measure: Sarcopenia
timeFrame: Before liver resection
measure: Time from diagnosis to liver resection
timeFrame: from 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
measure: Impact of PET CT on overall survival following liver resection
timeFrame: Before liver resection
Locations:
city: Creteil
country: France
facility: Henri Mondor University Hospital
Study officials:
affiliation: Henri Mondor
name: Daniel Azoulay, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ishizawa T, Hasegawa K, Aoki T, Takahashi M, Inoue Y, Sano K, Imamura H, Sugawara Y, Kokudo N, Makuuchi M. Neither multiple tumors nor portal hypertension are surgical contraindications for hepatocellular carcinoma. Gastroenterology. 2008 Jun;134(7):1908-16. doi: 10.1053/j.gastro.2008.02.091. Epub 2008 Mar 8.
citation: Lim C, Salloum C, Chalaye J, Lahat E, Costentin CE, Osseis M, Itti E, Feray C, Azoulay D. 18F-FDG PET/CT predicts microvascular invasion and early recurrence after liver resection for hepatocellular carcinoma: A prospective observational study. HPB (Oxford). 2019 Jun;21(6):739-747. doi: 10.1016/j.hpb.2018.10.007. Epub 2018 Nov 3.
citation: Lim C, Osseis M, Lahat E, Doussot A, Sotirov D, Hemery F, Lanteri-Minet M, Feray C, Salloum C, Azoulay D. Safety of laparoscopic hepatectomy in patients with hepatocellular carcinoma and portal hypertension: interim analysis of an open prospective study. Surg Endosc. 2019 Mar;33(3):811-820. doi: 10.1007/s00464-018-6347-1. Epub 2018 Jul 12.
citation: Lim C, Salloum C, Osseis M, Lahat E, Gomez-Gavara C, Compagnon P, Luciani A, Feray C, Azoulay D. Short-term outcomes following hepatectomy for hepatocellular carcinoma within and beyond the BCLC guidelines: A prospective study. HPB (Oxford). 2018 Mar;20(3):222-230. doi: 10.1016/j.hpb.2017.08.027. Epub 2017 Sep 19.