ALLPS VERSUS PVO Randomized Controlled Trial (ALPPS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01775267
First received: January 22, 2013
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • rate of hypertrophy over time [ Time Frame: 2012 to 2015 ] [ Designated as safety issue: No ]
  • Complications of treatment [ Time Frame: 2012-2015 ] [ Designated as safety issue: Yes ]
  • Progression of disease [ Time Frame: 2012-2015 ] [ Designated as safety issue: No ]
    Progression free survival

  • Postoperative liver and renal function [ Time Frame: 2012 to 2015 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775267

Contacts
Contact: Erik Schadde, MD +41 (0)44 255 11 11 erik.schadde@usz.ch

Locations
United States, Missouri
Washington University Not yet recruiting
St. Louis, Missouri, United States
Contact: Steven Strasberg, MD PhD       strasberg@wudosis.wustl.edu   
Principal Investigator: Steven Strasberg, MD PhD         
Argentina
Italian Hospital, Department of Surgery, Division of HPB surgery and Liver Transplatn Unit Not yet recruiting
Buenos Aires, Argentina
Contact: Victoria Ardiles, MD       victoria.ardiles@hospitalitaliano.org.ar   
Principal Investigator: Eduardo De Santibanes, MD         
Switzerland
University Hospital Zurich, Division of Visceral and Transplant Surgery Recruiting
Zurich, ZH, Switzerland, 8091
Contact: Erik Schadde, MD       erik.schadde@usz.ch   
Principal Investigator: Pierre-Alain Clavien, MD PhD         
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Erik Schadde, MD University Hospital Zurich, Division of Visceral and Transplant Surgery
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01775267     History of Changes
Other Study ID Numbers: USZ-ZH-VIS-ALPPS
Study First Received: January 22, 2013
Last Updated: January 23, 2013
Health Authority: Switzerland: Swissmedic
United States: Food and Drug Administration
Argentina: Ministry of Health

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 29, 2014