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

NCT ID: NCT00827723

Last Updated: 2018-11-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2018-11-30

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Alcoholic

Alcoholic cirrhotic patient with resectable hepatocellular carcinoma

No interventions assigned to this group

Viral

Viral cirrhotic patient with resectable hepatocellular carcinoma

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Nicolas DEMARTINES

professor of surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diana Michele, MD

Role: PRINCIPAL_INVESTIGATOR

CHUV University Hospital of Lausanne

Halkic Nermin, PD

Role: STUDY_DIRECTOR

CHUV University Hospital of Lausanne

Demartines Nicolas, Professeur

Role: STUDY_CHAIR

CHUV University Hospitals of Lausanne

Locations

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 18205256 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14609867 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10487594 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 14667750 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8831597 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33891139 (View on PubMed)

Other Identifiers

251/08

Identifier Type: -

Identifier Source: org_study_id