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Liver Tumors Not Resectable in One Surgical ProcedurePhase 2ALPPSNCT01775267

ALLPS VERSUS PVO Randomized Controlled Trial

A Phase 2 study testing Associating liver partition and portal vein ligation for staged hepatectomy and Portal vein embolization or ligation in people with Liver Tumors Not Resectable in One Surgical Procedure, run by University of Zurich at 3 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Associating liver partition and portal vein ligation for staged hepatectomy and Portal vein embolization or ligation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
3 sitesin 3 countries
Study dates
Nov 2012to Nov 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

United States1 site
  • Washington University

    St Louis, Missouri

Other trials in United States

Argentina1 site
  • Italian Hospital, Department of Surgery, Division of HPB surgery and Liver Transplatn Unit

    Buenos Aires

Other trials in Argentina

Switzerland1 site
  • University Hospital Zurich, Division of Visceral and Transplant Surgery

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

About this study

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

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
Being tested
Associating liver partition and portal vein ligation for staged hepatectomy, Portal vein embolization or ligation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Associating liver partition and portal vein ligation for staged hepatectomyProcedure or surgery

  • Portal vein embolization or ligationProcedure or surgery

Study groups in NCT01775267
Study groupRoleWhat they receive
ALPPSExperimentalPatients undergo Liver partition and portal vein ligation to induce hypertrophy of the future liver remnant
Receives: Procedure: Associating liver partition and portal vein ligation for staged hepatectomy
PVOActive comparatorPatient undergo portal vein embolization or ligation
Receives: Procedure: Portal vein embolization or ligation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Liver free of tumors [ Time Frame: At 3 months ] [ Designated as safety issue: No ]

    Measured: 2012 to 2015

Secondary outcomes (4)
  1. rate of hypertrophy over time

    Measured: 2012 to 2015

  2. Complications of treatment

    Measured: 2012-2015

  3. Progression of disease

    Progression free survival

    Measured: 2012-2015

  4. Postoperative liver and renal function

    Measured: 2012 to 2015

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2013 (estimated)
  2. Study startNov 2012
  3. Primary completionNov 2015 (estimated)
  4. Study completionNov 2015 (estimated)

Why it stopped: Study stopped due to safety concerns in both study arms

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01775267
Sponsor's protocol ID
USZ-ZH-VIS-ALPPS
Acronym
ALPPS
Status last verified
Jun 2015
First submitted
22 Jan 2013
Last updated
9 Jun 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Associating liver partition and portal vein ligation for staged hepatectomy and Portal vein embolization or ligation in people with Liver Tumors Not Resectable in One Surgical Procedure, run by University of Zurich at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Argentina, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study stopped due to safety concerns in both study arms). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Liver free of tumors [ Time Frame: At 3 months ] [ Designated as safety issue: No ] (time frame: 2012 to 2015). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2015.

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