CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 58 enrolled
Drug / intervention
Hepatectomyprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01683357
NCT01683357N/ACompleted

LONG-TERM RESULTS AFTER ONE-STAGE ULTRASOUND-GUIDED HEPATECTOMY IN PATIENTS WITH MULTIPLE BILOBAR COLORECTAL LIVER METASTASES: TOWARDS NEW CONCEPTS OF RADICAL RESECTION BY MEANS OF AN INTENTION TO TREAT ANALYSES

University of Milan·observational·Posted Sep 11, 2012·Updated Sep 11, 2012

In Brief

An observational study evaluating Hepatectomy for Liver Metastases. Completed, enrolled 58 participants across 1 site.

Detailed Summary

It is not rare that two-stage hepatectomy for multiple bilobar colorectal liver metastases (CLM) be left incomplete because of disease progression or technical reasons. One-stage hepatectomy seems a feasible and safe alternative, however, long-term results are lacking. This study aims to provide evidence that one-stage hepatectomy compelling tumor exposure provides adequate long-term results with low risk of local recurrences.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 11, 2012
Enrollment StartSep 1, 2001
Primary CompletionMar 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10.5 yearsPosted 13.8 years ago

Interventions

Hepatectomyprocedure

Intraoperative ultrasound (IOUS) criteria for tumor-vessel relations let maximizing the preservation of the hepatic vascular skeleton. Contact between colorectal liver metastases and a major intrahepatic vessel is not by itself a criteria for vessel resection: tumor exposure is not contraindicated. If resection of a hepatic vein (HV), resection of the liver parenchyma drained by that vein is considered or not based on color-flow IOUS findings (hepatofugal blood flow in the feeding portal branch, evidence or not of communicating veins between adjacent HVs, evidence or not of accessory HVs). Parenchymal transection is performed under intermittent clamping by the Pringle maneuver. Drains are always inserted and a chest tube is inserted in patients undergoing thoracophrenolaparotomy.