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.
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
- Conditions the study is for
- Liver Tumors Not Resectable in One Surgical Procedure
- 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
Argentina1 site
Italian Hospital, Department of Surgery, Division of HPB surgery and Liver Transplatn Unit
Buenos Aires
Switzerland1 site
University Hospital Zurich, Division of Visceral and Transplant Surgery
Zurich, Canton of Zurich, 8091
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 group | Role | What they receive |
|---|---|---|
| ALPPS | Experimental | Patients 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 |
| PVO | Active comparator | Patient 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.
Liver free of tumors [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
Measured: 2012 to 2015
Secondary outcomes (4)
rate of hypertrophy over time
Measured: 2012 to 2015
Complications of treatment
Measured: 2012-2015
Progression of disease
Progression free survival
Measured: 2012-2015
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.
- First posted24 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Why it stopped: Study stopped due to safety concerns in both study arms
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Tumors Not Resectable in One Surgical ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01775267
- Acronym / sponsor ID
- ALPPS / USZ-ZH-VIS-ALPPS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to safety concerns in both study arms
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALPPS | Experimental | Procedure: Associating liver partition and portal vein ligation for staged hepatectomyPatients undergo Liver partition and portal vein ligation to induce hypertrophy of the future liver remnant |
| PVO | Active comparator | Procedure: Portal vein embolization or ligationPatient undergo portal vein embolization or ligation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Associating liver partition and portal vein ligation for staged hepatectomy | Procedure or surgery | ALPPS |
| Portal vein embolization or ligation | Procedure or surgery | PVO |
Primary outcome
Liver free of tumors [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
Time frame: 2012 to 2015
4 secondary outcomes
rate of hypertrophy over time
Time frame: 2012 to 2015
Complications of treatment
Time frame: 2012-2015
Progression of disease
Time frame: 2012-2015
Postoperative liver and renal function
Time frame: 2012 to 2015
Results and safety
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.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
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.