NCT02145013

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

4.1 years

First QC Date

May 20, 2014

Last Update Submit

February 8, 2018

Conditions

Primary Liver Cancers

Keywords

portal hypertension, hepatocellular carcinoma, resection

Outcome Measures

Primary Outcomes (1)

  • Mortality

    In-hospital or 90-day mortality

    90 day

Secondary Outcomes (2)

  • morbidity

    90 day

  • Survival outcomes

    1,3 and 5 years

Other Outcomes (4)

  • Acute kidney injury

    within 90 days after surgery

  • Sarcopenia

    Before liver resection

  • Time from diagnosis to liver resection

    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

  • +1 more other outcomes

Study Arms (2)

Portal hypertension

Hepatectomy

Procedure: Liver resection

No portal hypertension

Hepatectomy

Procedure: Liver resection

Interventions

Liver resectionPROCEDURE

Hepatectomy by either open, laparoscopic or robotic procedures

No portal hypertensionPortal hypertension

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients with hepatocellular carcinoma

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Henri Mondor University Hospital

Créteil, 94000, France

Location

Related Publications (4)

  • 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.

    PMID: 18549877BACKGROUND

  • 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.

    PMID: 30401520DERIVED

  • 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.

    PMID: 30003350DERIVED

  • 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.

    PMID: 28935451DERIVED

MeSH Terms

Conditions

Hypertension, PortalCarcinoma, Hepatocellular

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Daniel Azoulay, MD PhD

    Henri Mondor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 22, 2014

Study Start

November 1, 2013

Primary Completion

December 1, 2017

Study Completion

May 30, 2018

Last Updated

February 12, 2018

Record last verified: 2018-02

Locations

FR(1)