ALLPS VERSUS PVO Randomized Controlled Trial

Phase 2

Terminated

• Conditions: Liver Tumors Not Resectable in One Surgical Procedure
• Interventions: Procedure: Associating liver partition and portal vein ligation for staged hepatectomy; Procedure: Portal vein embolization or ligation

• Registration Number: NCT01775267
• Lead Sponsor: University of Zurich

Brief Summary

This randomized phase II trial compares how well associating liver partition with portal vein ligation for staged hepatectomy (ALPPS) or portal vein occlusion (PVO) works in treating patients with liver cancer. Both treatments are types of 2-stage hepatectomies for removing liver cancer. ALPPS may be more effective than PVO in patients whose disease would traditionally be considered inoperable.

* Trial with surgical intervention

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-24
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-08
• Last Update Posted: 2015-06-09
• Primary Completion: 2015-11
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALPPS	Associating liver partition and portal vein ligation for staged hepatectomy	Patients undergo Liver partition and portal vein ligation to induce hypertrophy of the future liver remnant
PVO	Portal vein embolization or ligation	Patient undergo portal vein embolization or ligation

Primary Outcome Measures

Name	Time	Method
Liver free of tumors [ Time Frame: At 3 months ] [ Designated as safety issue: No ]	2012 to 2015

Secondary Outcome Measures

Name	Time	Method
rate of hypertrophy over time	2012 to 2015
Complications of treatment	2012-2015
Postoperative liver and renal function	2012 to 2015
Progression of disease	2012-2015	Progression free survival

Trial Locations

Locations (3)

Italian Hospital, Department of Surgery, Division of HPB surgery and Liver Transplatn Unit; 🇦🇷 Buenos Aires, Argentina

Washington University; 🇺🇸 St. Louis, Missouri, United States

University Hospital Zurich, Division of Visceral and Transplant Surgery; 🇨🇭 Zurich, ZH, Switzerland