Prognostic Impact of Anatomical Resection Vs. Non-anatomical Resection for HCC

Overall Survival Clinical Trial

— ARversusNAR  

Official title:

Anatomical Liver Resection by Means of Ultrasound-guided Vessel Compression Versus Non-anatomical Resection for Hepatocellular Carcinoma: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01236989
• Other study ID #: AR vs NAR
• Status: Not yet recruiting
• Phase: N/A
• First received: October 29, 2010
• Last updated: November 8, 2010
• Start date: January 2011
• Est. completion date: December 2017

Study information

• Verified date: October 2010
• Source: University of Milan
• Contact: Guido Torzilli, MD, PhD
• Phone: +39 02 8224
• Email: guido.torzilli[@]unimi.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Prognostic impact of AR vs NAR

Description:

Whether anatomical is better than non anatomical resection for HCC is still debated. This prospective randomized study aimed to address which approach is better in terms of patients prognosis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patient affected by single HCC

• patients in whom liver resection is indicated

• HCC without vascular invasion and/or thrombosis

Exclusion Criteria:

• multinodular HCC

• metastatic disease

• spontaneous tumor rupture

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Disease-Free Survival
• Overall Survival
• Patients Affected by Hepatocellular Carcinoma

Intervention

Procedure:
• anatomical liver resection
anatomical liver resection by means of IOUS-finger compression
• Non-anatomical liver resection
non-anatomical liver resection

Locations

Country	Name	City	State
Italy	IRCCS Istituto Clinico Humanitas	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Hasegawa K, Kokudo N, Imamura H, Matsuyama Y, Aoki T, Minagawa M, Sano K, Sugawara Y, Takayama T, Makuuchi M. Prognostic impact of anatomic resection for hepatocellular carcinoma. Ann Surg. 2005 Aug;242(2):252-9. — View Citation

Torzilli G, Makuuchi M. Ultrasound-guided finger compression in liver subsegmentectomy for hepatocellular carcinoma. Surg Endosc. 2004 Jan;18(1):136-9. Epub 2003 Nov 21. — View Citation

Torzilli G, Procopio F, Cimino M, Del Fabbro D, Palmisano A, Donadon M, Montorsi M. Anatomical segmental and subsegmental resection of the liver for hepatocellular carcinoma: a new approach by means of ultrasound-guided vessel compression. Ann Surg. 2010 Feb;251(2):229-35. doi: 10.1097/SLA.0b013e3181b7fdcd. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the prognostic impact of anatomical resection by means of intraoperative ultrasound (IOUS) guided vessel compression versus nonanatomical resection in terms of disease free and overall survival		5-years	No
Secondary	the impact of anatomical resection versus non-anatomical resection in terms of postoperative mortality and morbility		30 and 90 days	Yes