Portal Hypertension and Liver Resection in Patients With Hepatocellular Carcinoma

Primary Liver Cancers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02145013
• Other study ID #: LIM Chetana
• Status: Active, not recruiting
• Phase: N/A
• First received: May 20, 2014
• Last updated: February 8, 2018
• Start date: November 2013
• Est. completion date: May 30, 2018

Study information

• Verified date: February 2018
• Source: Henri Mondor University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: May 30, 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hypertension
• Hypertension, Portal
• Liver Neoplasms
• Primary Liver Cancers

Intervention

Procedure:
• Liver resection
Hepatectomy by either open, laparoscopic or robotic procedures

Locations

Country	Name	City	State
France	Henri Mondor University Hospital	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Henri Mondor University Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acute kidney injury	As defined by the KDIGIO criteria	within 90 days after surgery
Other	Sarcopenia	using computed tomography	Before liver resection
Other	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
Other	Impact of PET CT on overall survival following liver resection	quantitative assessment of metabolic uptake (FDG and choline)	Before liver resection
Primary	Mortality	In-hospital or 90-day mortality	90 day
Secondary	morbidity	Overall and liver-related complications including liver failure, ascites, biliary fistula, bleeding, pulmonary complications, and renal complications.; Grading system according to Clavien-Dindo classification	90 day
Secondary	Survival outcomes	Including Overall survival and disease free survival	1,3 and 5 years