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ALLPS VERSUS PVO Randomized Controlled Trial (ALPPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01775267
Recruitment Status : Terminated (Study stopped due to safety concerns in both study arms)
First Posted : January 24, 2013
Last Update Posted : June 9, 2015
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
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
Study Start Date : November 2012
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

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

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01775267

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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
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Responsible Party: University of Zurich Identifier: NCT01775267    
Other Study ID Numbers: USZ-ZH-VIS-ALPPS
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: June 9, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases