Communicating Veins Between Adjacent Hepatic Veins: an Intra-operative Ultrasound Study

Liver Tumors Clinical Trial

Official title:

Communicating Veins Between Adjacent Hepatic Veins: Rare, Exceptional or Frequent? An Intra-operative Ultrasound Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960609
• Other study ID #: CV-HV
• Status: Completed
• Phase: N/A
• First received: August 17, 2009
• Last updated: August 17, 2009
• Start date: January 2008

Study information

• Verified date: August 2009
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Description:

The search for communicating veins (CVs) between adjacent hepatic veins (HVs) has drawn its rationale from the need of reducing the risk of incomplete blood outflow in the medial portion of the hemiliver without the middle hepatic vein (MHV) in living donor liver transplantation (LDLT). However, only 24% of patients seems having CVs based on the findings of color-Doppler intraoperative ultrasound (CD-IOUS) exploration. On the other hand the safety of parenchymal sparing procedure despite HV resection let suppose that CVs are probably more frequent than expected.

Certainly, better in vivo knowledge of the rate of CVs and their direct detection would consolidate and probably further expand parenchymal sparing techniques. Taking profit from new advancements in ultrasound technology we have carried out the present study with the aim of better estimating the rate of CVs in a consecutive series of patients in whom resection of one HV at caval confluence was needed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Neoplasms
• Liver Tumors

Intervention

Procedure:
• Ultrasound guided liver resection

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas, IRCCS	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First outcome was the rate of CVs detectable with e-flow IOUS along clamping of the HV for which resection could be needed.			No
Secondary	Secondary outcome was safety (morbidity, mortality, blood loss, blood transfusions) of the procedure.			Yes