Portal Hypertension and Liver Resection in Patients With Hepatocellular Carcinoma

• ClinicalTrials.gov Identifier: NCT02145013
• Recruitment Status: Unknown
• First Posted: May 22, 2014
• Last Update Posted: February 12, 2018
• Sponsor: Henri Mondor University Hospital
• Information provided by (Responsible Party): Chetana LIM, Henri Mondor University Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Primary Liver Cancers	Procedure: 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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Assessment and Impact of Portal Hypertension Before and During Liver Resection in Patients With Hepatocellular Carcinoma
• Study Start Date: November 2013
• Actual Primary Completion Date: December 2017
• Estimated Study Completion Date: May 30, 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
Portal hypertension; Hepatectomy	Procedure: Liver resection; Hepatectomy by either open, laparoscopic or robotic procedures
No portal hypertension; Hepatectomy	Procedure: Liver resection; Hepatectomy by either open, laparoscopic or robotic procedures

Outcome Measures

Primary Outcome Measures :

1. Mortality [ Time Frame: 90 day ]
   In-hospital or 90-day mortality

Secondary Outcome Measures :

1. morbidity [ Time Frame: 90 day ]

   Overall and liver-related complications including liver failure, ascites, biliary fistula, bleeding, pulmonary complications, and renal complications.

   Grading system according to Clavien-Dindo classification

2. Survival outcomes [ Time Frame: 1,3 and 5 years ]
   Including Overall survival and disease free survival

Other Outcome Measures:

1. Acute kidney injury [ Time Frame: within 90 days after surgery ]
   As defined by the KDIGIO criteria
2. Sarcopenia [ Time Frame: Before liver resection ]
   using computed tomography
3. Time from diagnosis to liver resection [ Time Frame: 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 ]
4. Impact of PET CT on overall survival following liver resection [ Time Frame: Before liver resection ]
   quantitative assessment of metabolic uptake (FDG and choline)

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

All patients with hepatocellular carcinoma

Criteria

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

Contacts and Locations

Locations

France

Henri Mondor University Hospital

Creteil, France, 94000

Sponsors and Collaborators

Henri Mondor University Hospital

Investigators

• Principal Investigator: Daniel Azoulay, MD PhD; Henri Mondor

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Lim C, Osseis M, Lahat E, Doussot A, Sotirov D, Hemery F, Lantéri-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.

Lim C, Salloum C, Osseis M, Lahat E, Gómez-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.

• Responsible Party: Chetana LIM, MD, Henri Mondor University Hospital
• ClinicalTrials.gov Identifier: NCT02145013
• Other Study ID Numbers: LIM Chetana
• First Posted: May 22, 2014
• Last Update Posted: February 12, 2018
• Last Verified: February 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Chetana LIM, Henri Mondor University Hospital:

portal hypertension, hepatocellular carcinoma, resection

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Hepatocellular; Hypertension, Portal; Hypertension; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Vascular Diseases; Cardiovascular Diseases; Adenocarcinoma; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases