ALLPS VERSUS PVO Randomized Controlled Trial

NCT ID: NCT01775267

Last Updated: 2015-06-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-11-30

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

Conditions

Liver Tumors Not Resectable in One Surgical Procedure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ALPPS

Patients undergo Liver partition and portal vein ligation to induce hypertrophy of the future liver remnant

Group Type: EXPERIMENTAL

Associating liver partition and portal vein ligation for staged hepatectomy

Intervention Type: PROCEDURE

PVO

Patient undergo portal vein embolization or ligation

Group Type: ACTIVE_COMPARATOR

Portal vein embolization or ligation

Intervention Type: PROCEDURE

Interventions

Associating liver partition and portal vein ligation for staged hepatectomy

Intervention Type: PROCEDURE

Portal vein embolization or ligation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient must have extensive liver tumors that would require portal vein embolization or a two-stage hepatectomy and portal vein embolization or ligation by the judgment of surgeons in the tumor board.
• Patient may have extrahepatic disease as long as it may be addressed after liver surgery and there is a tumor board decision to proceed with liver resection (mostly applicable to CRC metastases).
• Patient may have received previous chemotherapy.
• In cases of cholestasis, preoperative drainage procedures (PTC or ERCP) are left up to judgement of physicians.
• Patient must be = 18 years of age. The patient population over 65 years old needs to be carefully included based on comorbidities.
• Patient may have undergone previous liver resection.
• Patient's location must be such that proper staging and follow-up may be performed.
• Patient's case must be presented at the Multidisciplinary Meeting attended by hepatobiliary surgeons, oncologists, hepatologists, and radiologists, or must be approved directly by Dr. Strasberg or Dr. Chapman.

Exclusion Criteria

• Patient must not have enrolled into a clinical trial within 4 weeks of study entry.
• Patient must not have peritoneal carcinomatosis or other extensive extrahepatic disease.
• Patient must not have advanced stages of carcinoma of the gallbladder (T3/T4)
• Patient must not have issues such as drug and/or alcohol abuse.
• Patient must not need major extrahepatic surgery (e.g. pancreas resection, gastric resection, rectal surgery) within 3 months of study entry.
• Patient must not be a candidate for liver transplantation in case of HCC.
• Patient must not be pregnant or breastfeeding. If a female of childbearing potential, patient must have a negative pregnancy test within 14 days of enrollment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Washington University

St Louis, Missouri, United States

Italian Hospital, Department of Surgery, Division of HPB surgery and Liver Transplatn Unit

Buenos Aires, , Argentina

University Hospital Zurich, Division of Visceral and Transplant Surgery

Zurich, Canton of Zurich, Switzerland

Countries

United States; Argentina; Switzerland

Other Identifiers

USZ-ZH-VIS-ALPPS

Identifier Type: -

Identifier Source: org_study_id