ALLPS VERSUS PVO Randomized Controlled Trial (ALPPS)

ASSOCIATING LIVER PARTITION WITH PORTAL VEIN LIGATION FOR STAGED HEPATECTOMY (ALPPS) Versus Conventional Portal Vein Occlusion (PVO) for Resection of Liver Tumors Unresectable in One Step - a Randomized Controlled Trial

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Italian Hospital, Department of Surgery, Division of HPB surgery and Liver Transplatn Unit
• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • University Hospital Zurich, Division of Visceral and Transplant Surgery
• United States
  • Missouri
    • St. Louis, Missouri, United States
      • Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria: •Patient may have primary or secondary hepatic malignancies with a FLR/TLV < 30% or a FLR/BW ratio of < 0.5 for patients with normal liver function (defined as normal transaminases, normal bilirubin, normal factor V, and normal PT/INR). In case of injury due to chemotherapy, known high grade steatosis, or cholestasis > 50 mmol/L, patient may be enrolled into the trial if FLR/TLV is < 40% or FLR/BW ratio < 0.8.

• 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 any significant concomitant diseases rendering him/her unsuitable for major liver surgery by the judgment of the physicians involved, especially if the patient is > 65 years old.

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ALPPS; Patients undergo Liver partition and portal vein ligation to induce hypertrophy of the future liver remnant	Procedure: Associating liver partition and portal vein ligation for staged hepatectomy
ACTIVE_COMPARATOR: PVO; Patient undergo portal vein embolization or ligation	Procedure: Portal vein embolization or ligation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of hypertrophy over time		2012 to 2015
Complications of treatment		2012-2015
Progression of disease	Progression free survival	2012-2015
Postoperative liver and renal function		2012 to 2015

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ANTICIPATED): November 1, 2015
• Study Completion (ANTICIPATED): November 1, 2015

Study Registration Dates

• First Submitted: January 22, 2013
• First Submitted That Met QC Criteria: January 23, 2013
• First Posted (ESTIMATE): January 24, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 9, 2015
• Last Update Submitted That Met QC Criteria: June 8, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: USZ-ZH-VIS-ALPPS