Portal Hypertension and Liver Resection in Patients With Hepatocellular Carcinoma

NCT ID: NCT02145013

Last Updated: 2018-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2018-05-30

Brief Summary

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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

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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.

Conditions

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Primary Liver Cancers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Portal hypertension

Hepatectomy

Liver resection

Intervention Type PROCEDURE

Hepatectomy by either open, laparoscopic or robotic procedures

No portal hypertension

Hepatectomy

Liver resection

Intervention Type PROCEDURE

Hepatectomy by either open, laparoscopic or robotic procedures

Interventions

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Liver resection

Hepatectomy by either open, laparoscopic or robotic procedures

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henri Mondor University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chetana LIM

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Azoulay, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Henri Mondor

Locations

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Henri Mondor University Hospital

Créteil, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 18549877 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30401520 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30003350 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28935451 (View on PubMed)

Other Identifiers

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LIM Chetana

Identifier Type: -

Identifier Source: org_study_id

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