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Laparoscopic Microwave Ablation and Portal Vein Ligation for Staged Hepatectomy (LAPS)

NCT02184182 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-07-09

No results posted yet for this study

Summary

One of the limiting factors in the execution of a liver resection, in particular an extended liver resection, it's represented by the future remnant liver (FRL) after hepatic surgery. In cases of normal organ function an FRL of 25% is considered sufficient. In case of impaired hepatic function or a history of chemotherapy, it is considered safe if at least of 40%.

Many strategies have been developed and proposed to increase the resectability in patients undergoing major liver resections.

One of these is a new two-stage technique proposed recently by a group of German surgeons. This approach consists in the ligation of the right portal vein associated with resection of the liver along the falciform ligament (step 1). Step 2, after a period of 9 days (median - 5-25 days), after a volumetric CT to ensure an adeguate hypertrophy of the left lateral lobe due to the combination of right portal occlusion and segment 4 devascularization, the patient undergo a right trisectionectomy. The hypertrophy of the left lateral lobe is shown to be of 74%, higher than any other techniques of ligation or portal embolizatiol proposed in the literature.

On the basis of the clinical experiences reported the investigators designed a new protocol of two-stage hepatic resection for the treatment of primary or secondary tumors of the right lobe. Step1: laparoscopic radio frequency / microwave ablation of the future transection plane between segment 4 and left lateral lobe and surgical ligation or embolization of the right portal vein. The ablation has the purpose to devascularize the segment 4 and has the same significance of the resection of the liver along the falciform ligament described by the Regensburg group.

Step2: After a period of time of 9 ± 2 days, following a volumetric CT showing an adequate liver volume gain (ratio FRL / patient body weight\> 0.5), the patient undergo the second-stage surgery: laparoscopic/ laparotomic right trisectionectomy.

Conditions

  • Liver Tumors

Interventions

PROCEDURE

VLS ablation/portal ligation/hepatectomy

Step1: * exploratory laparoscopy to exclude extrahepatic disease * right portal vein ligation if surgically feasible * RF/MW ablation on the future line of transection (of segment 4 close to left lateral lobe) * radiological portal embolization within 48h form the laparoscopic procedure if the right portal vein ligation is not feasible CT volumetric scan to evaluate the left lateral lobe hypertrophy after 9±2 from Step 1 Step 2: only if FRL/body weight \> 0.5 \- laparoscopic/laparotomic right trisectionectomy

Sponsors & Collaborators

  • Azienda Ospedaliera di Padova

    lead OTHER

Principal Investigators

  • Umberto Cillo, MD PhD · Azienda Ospedaliera di Padova

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-06-30
Completion
2017-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02184182 on ClinicalTrials.gov