Indocyanine Green and Portal Pressure in Viral and Alcoholic Cirrhotic Patients With Hepatocarcinoma

NCT00827723 | Completed DMC

• 1 other identifier: 251/08
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the investigators' study is to elucidate the relationship between a functional liver test (e.g., ICG) and the PREOPERATIVE value of portal hypertension in the patients with impaired liver function from alcoholic and non-alcoholic aetiologies. Alcoholic and viral cirrhosis present important differences in terms of cellular mechanisms responsible for the disease progression with a distinct and unique gene expression pattern that regulates the type of inflammatory response. These differences probably influence the hepatic functional reserve and the onset of portal hypertension at a comparable clinical and biological level of derangement and the investigators may expect significant differences in the recovery from hepatectomy. The investigators' hypothesis is that at a comparable ICGR-15 rate non-viral cirrhotic liver presents higher portal pressure values and the investigators also argue that alcoholic cirrhotic patients would tolerate a larger hepatic resection than would viral cirrhotic do.

Conditions

Carcinoma, Hepatocellular; Alcoholic Cirrhosis; Viral Cirrhosis; Postoperative Hepatic Failure

Keywords

Hepatic functional reserve; Hepatocellular carcinoma (HCC); Indocyanine Green retention rate at 15 minutes (ICG-R15'); Portal Pressure (PP); Hepatic Portal Venous Gradient (HPVG); Alcoholic and Viral Cirrhosis; Makuuchi criteria; Barcelona Clinic of Liver Cancer (BCLC); Hepatic resection

Outcome Measures

Primary Outcomes (1)

• concordance rate between ICGR-15 and Portal Pressure values in patients with resectable HCC and cirrhosis Child A from alcoholic and non-alcoholic origin.

  1 year

Secondary Outcomes (1)

• postoperative liver failure.

  1 year

Study Arms (2)

Alcoholic

Alcoholic cirrhotic patient with resectable hepatocellular carcinoma

Viral

Viral cirrhotic patient with resectable hepatocellular carcinoma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

• resectable or amenable to resection HCC in cirrhotic child A patients of alcoholic or viral etiology

You may not qualify if:

• cirrhosis Child-Pugh B
• absence of patient consent
• psychiatric pathology

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1005, Switzerland

Location

Related Publications (6)

• Yamazaki S, Takayama T. Surgical treatment of hepatocellular carcinoma: evidence-based outcomes. World J Gastroenterol. 2008 Feb 7;14(5):685-92. doi: 10.3748/wjg.14.685.

  PMID: 18205256 BACKGROUND

• Imamura H, Seyama Y, Kokudo N, Maema A, Sugawara Y, Sano K, Takayama T, Makuuchi M. One thousand fifty-six hepatectomies without mortality in 8 years. Arch Surg. 2003 Nov;138(11):1198-206; discussion 1206. doi: 10.1001/archsurg.138.11.1198.

  PMID: 14609867 BACKGROUND

• Torzilli G, Makuuchi M, Inoue K, Takayama T, Sakamoto Y, Sugawara Y, Kubota K, Zucchi A. No-mortality liver resection for hepatocellular carcinoma in cirrhotic and noncirrhotic patients: is there a way? A prospective analysis of our approach. Arch Surg. 1999 Sep;134(9):984-92. doi: 10.1001/archsurg.134.9.984.

  PMID: 10487594 BACKGROUND

• Llovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet. 2003 Dec 6;362(9399):1907-17. doi: 10.1016/S0140-6736(03)14964-1.

  PMID: 14667750 BACKGROUND

• Bruix J, Castells A, Bosch J, Feu F, Fuster J, Garcia-Pagan JC, Visa J, Bru C, Rodes J. Surgical resection of hepatocellular carcinoma in cirrhotic patients: prognostic value of preoperative portal pressure. Gastroenterology. 1996 Oct;111(4):1018-22. doi: 10.1016/s0016-5085(96)70070-7.

  PMID: 8831597 BACKGROUND

• Kobayashi K, Uldry E, Kokudo T, Cristaudi A, Kawaguchi Y, Shirata C, Yamaguchi T, Dormond O, Duran R, Hasegawa K, Demartines N, Halkic N. Correlation Between Portal Pressure and Indocyanine Green Retention Rate is Unaffected by the Cause of Cirrhosis: A Prospective Study. World J Surg. 2021 Aug;45(8):2546-2555. doi: 10.1007/s00268-021-06111-6. Epub 2021 Apr 23.

  PMID: 33891139 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Cirrhosis, Alcoholic

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Liver Diseases, Alcoholic; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Diana Michele, MD

  CHUV University Hospital of Lausanne

  PRINCIPAL INVESTIGATOR

• Halkic Nermin, PD

  CHUV University Hospital of Lausanne

  STUDY DIRECTOR

• Demartines Nicolas, Professeur

  CHUV University Hospitals of Lausanne

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of surgery

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 23, 2009
• Study Start: February 1, 2009
• Primary Completion: February 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 13, 2018

Record last verified: 2018-11

Locations

CH (1)