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ALLPS VERSUS PVO Randomized Controlled Trial (ALPPS)

This study has been terminated.
(Study stopped due to safety concerns in both study arms)
Information provided by (Responsible Party):
University of Zurich Identifier:
First received: January 22, 2013
Last updated: June 8, 2015
Last verified: June 2015

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

Condition Intervention Phase
Liver Tumors Not Resectable in One Surgical Procedure Procedure: Associating liver partition and portal vein ligation for staged hepatectomy Procedure: Portal vein embolization or ligation Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by University of Zurich:

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

Secondary Outcome Measures:
  • rate of hypertrophy over time [ Time Frame: 2012 to 2015 ]
  • Complications of treatment [ Time Frame: 2012-2015 ]
  • Progression of disease [ Time Frame: 2012-2015 ]
    Progression free survival

  • Postoperative liver and renal function [ Time Frame: 2012 to 2015 ]

Enrollment: 7
Study Start Date: November 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01775267

United States, Missouri
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, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
  More Information

Responsible Party: University of Zurich Identifier: NCT01775267     History of Changes
Other Study ID Numbers: USZ-ZH-VIS-ALPPS
Study First Received: January 22, 2013
Last Updated: June 8, 2015

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on August 18, 2017