NCT00960609

Brief Summary

The search for communicating veins (CVs) between adjacent hepatic veins (HVs) has drawn its rationale from living donor liver transplantation (LDLT). Parenchymal sparing procedures although HVs are resected suggest that probably their presence is underestimated. Taking profit from new improvements in ultrasound technology the investigators aim to better estimate the rate of CVs in a consecutive series of patients in whom resection of one HV at caval confluence is needed.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2009

Completed
Last Updated

August 18, 2009

Status Verified

August 1, 2009

First QC Date

August 17, 2009

Last Update Submit

August 17, 2009

Conditions

Keywords

Communicating veinshepatic venous anastomosisintra-operative ultrasonographyhepatic resectionhepatic neoplasmPrimary and metastatic liver tumors

Outcome Measures

Primary Outcomes (1)

  • First outcome was the rate of CVs detectable with e-flow IOUS along clamping of the HV for which resection could be needed.

Secondary Outcomes (1)

  • Secondary outcome was safety (morbidity, mortality, blood loss, blood transfusions) of the procedure.

Study Arms (1)

caval confluence HV involvement

Patients carriers of primary or metastatic tumour with direct contact or invasion of one HV at the caval confluence.

Procedure: Ultrasound guided liver resection

Interventions

caval confluence HV involvement

Eligibility Criteria

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

Patients with primary and metastatic liver tumors addressed to surgical treatment

You may qualify if:

  • Patients suitable for being enrolled in the present study were those carriers of primary or metastatic tumour with direct contact or invasion of one HV at the caval confluence.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas, IRCCS

Rozzano, Milano, 20089, Italy

Location

Related Publications (6)

  • Torzilli G, Procopio F, Botea F, Marconi M, Del Fabbro D, Donadon M, Palmisano A, Spinelli A, Montorsi M. One-stage ultrasonographically guided hepatectomy for multiple bilobar colorectal metastases: a feasible and effective alternative to the 2-stage approach. Surgery. 2009 Jul;146(1):60-71. doi: 10.1016/j.surg.2009.02.017.

    PMID: 19541011BACKGROUND
  • Torzilli G, Donadon M, Marconi M, Palmisano A, Del Fabbro D, Spinelli A, Botea F, Montorsi M. Hepatectomy for stage B and stage C hepatocellular carcinoma in the Barcelona Clinic Liver Cancer classification: results of a prospective analysis. Arch Surg. 2008 Nov;143(11):1082-90. doi: 10.1001/archsurg.143.11.1082.

    PMID: 19015467BACKGROUND
  • Torzilli G, Donadon M, Marconi M, Botea F, Palmisano A, Del Fabbro D, Procopio F, Montorsi M. Systematic extended right posterior sectionectomy: a safe and effective alternative to right hepatectomy. Ann Surg. 2008 Apr;247(4):603-11. doi: 10.1097/SLA.0b013e31816387d7.

    PMID: 18362622BACKGROUND
  • Torzilli G, Donadon M, Palmisano A, Del Fabbro D, Spinelli A, Makuuchi M, Montorsi M. Back-flow bleeding control during resection of right-sided liver tumors by means of ultrasound-guided finger compression of the right hepatic vein at its caval confluence. Hepatogastroenterology. 2007 Jul-Aug;54(77):1364-7.

    PMID: 17708255BACKGROUND
  • Torzilli G, Montorsi M, Del Fabbro D, Palmisano A, Donadon M, Makuuchi M. Ultrasonographically guided surgical approach to liver tumours involving the hepatic veins close to the caval confluence. Br J Surg. 2006 Oct;93(10):1238-46. doi: 10.1002/bjs.5321.

    PMID: 16953487BACKGROUND
  • Sano K, Makuuchi M, Miki K, Maema A, Sugawara Y, Imamura H, Matsunami H, Takayama T. Evaluation of hepatic venous congestion: proposed indication criteria for hepatic vein reconstruction. Ann Surg. 2002 Aug;236(2):241-7. doi: 10.1097/00000658-200208000-00013.

    PMID: 12170030BACKGROUND

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2009

First Posted

August 18, 2009

Study Start

January 1, 2008

Last Updated

August 18, 2009

Record last verified: 2009-08

Locations