Locally Advanced Malignant Liver DiseaseNCT02164292
ALPPS: Safety, Feasibility and Efficacy at a Single Center
An observational study of Locally Advanced Malignant Liver Disease, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
The possibility to achieve a curative resection in patients with liver malignancies is limited by the future liver remnant (FLR). The Associating Liver Partition and Portal vein ligation for Staged hepatectomy (ALPPS) approach has recently been introduced as a revolutionary strategy to achieve resectability by… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Locally Advanced Malignant Liver Disease
- What is being tested?
- ALPPS
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteArgentina
- Study dates
- Jun 2011to Apr 2014
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: High-Volume University Hospital population
Who may be able to join
- Patients with marginally resectable or primarily non-resectable locally advanced liver tumors
- Insufficient FLR either in volume or quality
Who cannot join
- Unresectable liver metastases in the future liver remnant or unresectable extrahepatic metastases
- Severe portal hypertension
- High anesthesiological risk
- Unresectable primary tumor
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1181ACH
About this study
Official title: Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS): Safety, Feasibility and Efficacy at a Single Center
The possibility to achieve a curative resection in patients with liver malignancies is limited by the future liver remnant (FLR). The Associating Liver Partition and Portal vein ligation for Staged hepatectomy (ALPPS) approach has recently been introduced as a revolutionary strategy to achieve resectability by inducing a rapid and large FLR hypertrophy. However, the possibility of achieving a short-term hypertrophy and high resectability rates has been counteracted in most published series by an increased risk of morbidity and mortality.The aim of this study was to evaluate the results with the ALPPS procedure in a single high-volume HPB center, with special emphasis in the safety and feasibility of this new 2-stage strategy. The aim of the present study was to assess the safety, feasibility and efficacy of ALPPS in a single high-volume hepatobiliary center.
Read the detailed description
Complete resection of liver malignancies remains as the best treatment to offer the possibility of long-term survival or cure. At diagnosis, many patients have locally advanced disease that often precludes a curative resection. During the past two decades, a better assessment of resectability through modern imaging techniques along with new multimodal therapies and the introduction of modern chemotherapy regimens have allowed to increase the pool of candidates for surgical treatment in patients with locally advanced disease. The current principles for safe liver resections focus mainly on the liver parenchyma that remains after resection rather than the liver resected. In fact, one of the main conditioning factors of posthepatectomy liver failure (PHLF) is the amount and quality of future liver remnant (FLR). The induction of hypertrophy of healthy parenchyma using either portal vein embolization (PVE) or ligation (PVL), in the setting of 1-stage or 2-stage liver resections, is nowadays considered the standard of care for patients with locally advanced liver tumors and small FLR.2,5-8 However, the need for long intervals between interventions (6-12 weeks), results in resectability rates that rarely exceed 60-80%.
In 2012, Schnitbauer et al introduced a novel 2-stage technique that allowed tumor resection in 25 patients from 5 German centers with marginally resectable or primarily nonresectable disease by means of a rapid and large FLR hypertrophy. This technique was later popularized with the acronym ALPPS for "Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy". The promising preliminary results obtained with this new surgical proposal in terms of hypertrophy and the possibility of challenging the previous methods generated a pronounced reaction in the surgical community world-wide that has rarely been seen in the history of hepato-pancreato-biliary (HPB) surgery. However, the possibility of achieving a short-term hypertrophy and high resectability rates has been counteracted in most published series by an increased risk of morbidity and mortality. The aim of this study was to evaluate the results with the ALPPS procedure in a single high-volume HPB center, with special emphasis in the safety and feasibility of this new 2-stage strategy.
Data for all patients undergoing 2-stage hepatectomies with the ALPPS approach at the HPB Surgery Section of the Hospital Italiano de Buenos Aires between June 2011 and April 2014 was analyzed on an intention to treat basis. Patient demographics, clinical characteristics (body mass index, anesthesiological risk score, Charlson comorbidity index, preoperative chemotherapy), tumor type, surgical details, FLR hypertrophy, postoperative liver function, postoperative complications, length of hospital stay and survival were analyzed.
Regarding the surgical procedure, during the first stage a complete tumor resection (clean-up) of the FLR is performed if bilateral disease was present, either trough anatomical or atypical resections. Subsequently, the portal vein of the diseased hemi-liver (DH) is divided and either total (up to the inferior vena cava) or partial (up to the middle hepatic vein) parenchymal transection using the Cavitron Ultrasonic Surgical Aspirator (CUSA; Valley Lab, Boulder, CO, USA) is carried out. At the end of the first stage, the DH is either wrapped in a plastic bag or a plastic sheath placed between the cut surfaces. Once volumetric CT analysis demonstrated enough FLR hypertrophy and provided the patient is in good condition, the second stage is carried out the next available operative day resecting the DH. The type of liver resections performed were defined using the Brisbane 2000 nomenclature.
- Conditions
- Locally Advanced Malignant Liver Disease
- Being tested
- ALPPS
- Keywords
- Liver tumor, ALPPS, Two-stage hepatectomy, Morbidity, Hypertrophy
- Medical subject headings
- Carcinoma, Hepatocellular, Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALPPSProcedure or surgery
Associating Liver Partition and Portal vein ligation for Staged hepatectomy
| Study group | Role | What they receive |
|---|---|---|
| ALPPS group | Patients with small future liver remnant who are operated with the "Associating Liver Partition and Portal vein ligation for Staged hepatectomy" approach Receives: Procedure: ALPPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the procedure defined as the incidence of postoperative complications and mortality
Ocurrence of any postoperative complication or mortality considering the Dindo-Clavien classification of surgical complications
Measured: within the first 90 days after the first stage
Feasibility of the procedure defined as percentage of patients that complete both surgical stages.
Percentage of patients that finally arrive to the 2nd stage of the ALPPS approach
Measured: within 4 months after the first stage
Secondary outcomes (4)
Efficacy of the procedure defiend as the percentage of patients who achieve a sufficient future liver remnant hypertrophy
Achievement of sufficient short-term hypertrophy of the future liver remnant (FLR). Sufficiency was defined as a FLR >0.5% of body weight or >25% of standardized total liver volume in case of healthy liver parenchyma, or >0.8% and 40% in case of diseased parenchyma.
Measured: within 10 days after the first stage
Disease-free survival and overall survival
Disease free survival was the time that a patient remained alive and without evidence of disease from the second stage. Overall survival was the time from the first stage to patient death.
Measured: 1 and 2 years
Risk factors for morbidity
To identify clinical or operative risk factors of postoperative complications
Measured: within 3 month after the first stage
Risk factors for a reduced kinetic growth rate of the future liver remnant (<35 cc/day)
To identify clinical or operative risk factors or a reduced kinetic growth rate of the future liver remnant (<35 cc/day)
Measured: within 3 months after the first stage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startJun 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Malignant Liver DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires
- Investigators
- Eduardo de Santibañes, MD, PhD, Study director, General Surgery Service, Hospital Italiano de Buenos Aires. Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164292
- Sponsor's protocol ID
- 1942
- Status last verified
- Aug 2019
- First submitted
- 11 Jun 2014
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Agrawal S, Belghiti J. Oncologic resection for malignant tumors of the liver. Ann Surg. 2011 Apr;253(4):656-65. doi: 10.1097/SLA.0b013e3181fc08ca.
PubMed 21475004Clavien PA, Petrowsky H, DeOliveira ML, Graf R. Strategies for safer liver surgery and partial liver transplantation. N Engl J Med. 2007 Apr 12;356(15):1545-59. doi: 10.1056/NEJMra065156. No abstract available.
PubMed 17429086Mise Y, Sakamoto Y, Ishizawa T, Kaneko J, Aoki T, Hasegawa K, Sugawara Y, Kokudo N. A worldwide survey of the current daily practice in liver surgery. Liver Cancer. 2013 Jan;2(1):55-66. doi: 10.1159/000346225.
PubMed 24159597Schnitzbauer AA, Lang SA, Goessmann H, Nadalin S, Baumgart J, Farkas SA, Fichtner-Feigl S, Lorf T, Goralcyk A, Horbelt R, Kroemer A, Loss M, Rummele P, Scherer MN, Padberg W, Konigsrainer A, Lang H, Obed A, Schlitt HJ. Right portal vein ligation combined with in situ splitting induces rapid left lateral liver lobe hypertrophy enabling 2-staged extended right hepatic resection in small-for-size settings. Ann Surg. 2012 Mar;255(3):405-14. doi: 10.1097/SLA.0b013e31824856f5.
PubMed 22330038de Santibanes E, Clavien PA. Playing Play-Doh to prevent postoperative liver failure: the "ALPPS" approach. Ann Surg. 2012 Mar;255(3):415-7. doi: 10.1097/SLA.0b013e318248577d. No abstract available.
PubMed 22330039Shindoh J, Vauthey JN, Zimmitti G, Curley SA, Huang SY, Mahvash A, Gupta S, Wallace MJ, Aloia TA. Analysis of the efficacy of portal vein embolization for patients with extensive liver malignancy and very low future liver remnant volume, including a comparison with the associating liver partition with portal vein ligation for staged hepatectomy approach. J Am Coll Surg. 2013 Jul;217(1):126-33; discussion 133-4. doi: 10.1016/j.jamcollsurg.2013.03.004. Epub 2013 Apr 28.
PubMed 23632095Schadde E, Ardiles V, Slankamenac K, Tschuor C, Sergeant G, Amacker N, Baumgart J, Croome K, Hernandez-Alejandro R, Lang H, de Santibanes E, Clavien PA. ALPPS offers a better chance of complete resection in patients with primarily unresectable liver tumors compared with conventional-staged hepatectomies: results of a multicenter analysis. World J Surg. 2014 Jun;38(6):1510-9. doi: 10.1007/s00268-014-2513-3.
PubMed 24748319Torres OJ, Fernandes Ede S, Oliveira CV, Lima CX, Waechter FL, Moraes-Junior JM, Linhares MM, Pinto RD, Herman P, Machado MA. Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS): the Brazilian experience. Arq Bras Cir Dig. 2013 Jan-Mar;26(1):40-3. doi: 10.1590/s0102-67202013000100009. English, Portuguese.
PubMed 23702869
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS): Safety, Feasibility and Efficacy at a Single Center
- ClinicalTrials.gov ID
- NCT02164292
- Acronym / sponsor ID
- 1942
- Conditions
- Locally Advanced Malignant Liver Disease
- Keywords
- Liver tumor, ALPPS, Two-stage hepatectomy, Morbidity, Hypertrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 16 Jun 2014 (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.
The possibility to achieve a curative resection in patients with liver malignancies is limited by the future liver remnant (FLR). The Associating Liver Partition and Portal vein ligation for Staged hepatectomy (ALPPS) approach has recently been introduced as a revolutionary strategy to achieve resectability by inducing a rapid and large FLR hypertrophy. However, the possibility of achieving a short-term hypertrophy and high resectability rates has been counteracted in most published series by an increased risk of morbidity and mortality.The aim of this study was to evaluate the results with the ALPPS procedure in a single high-volume HPB center, with special emphasis in the safety and feasibility of this new 2-stage strategy. The aim of the present study was to assess the safety, feasibility and efficacy of ALPPS in a single high-volume hepatobiliary center.
Detailed description
Complete resection of liver malignancies remains as the best treatment to offer the possibility of long-term survival or cure. At diagnosis, many patients have locally advanced disease that often precludes a curative resection. During the past two decades, a better assessment of resectability through modern imaging techniques along with new multimodal therapies and the introduction of modern chemotherapy regimens have allowed to increase the pool of candidates for surgical treatment in patients with locally advanced disease. The current principles for safe liver resections focus mainly on the liver parenchyma that remains after resection rather than the liver resected. In fact, one of the main conditioning factors of posthepatectomy liver failure (PHLF) is the amount and quality of future liver remnant (FLR). The induction of hypertrophy of healthy parenchyma using either portal vein embolization (PVE) or ligation (PVL), in the setting of 1-stage or 2-stage liver resections, is nowadays considered the standard of care for patients with locally advanced liver tumors and small FLR.2,5-8 However, the need for long intervals between interventions (6-12 weeks), results in resectability rates that rarely exceed 60-80%.
In 2012, Schnitbauer et al introduced a novel 2-stage technique that allowed tumor resection in 25 patients from 5 German centers with marginally resectable or primarily nonresectable disease by means of a rapid and large FLR hypertrophy. This technique was later popularized with the acronym ALPPS for "Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy". The promising preliminary results obtained with this new surgical proposal in terms of hypertrophy and the possibility of challenging the previous methods generated a pronounced reaction in the surgical community world-wide that has rarely been seen in the history of hepato-pancreato-biliary (HPB) surgery. However, the possibility of achieving a short-term hypertrophy and high resectability rates has been counteracted in most published series by an increased risk of morbidity and mortality. The aim of this study was to evaluate the results with the ALPPS procedure in a single high-volume HPB center, with special emphasis in the safety and feasibility of this new 2-stage strategy.
Data for all patients undergoing 2-stage hepatectomies with the ALPPS approach at the HPB Surgery Section of the Hospital Italiano de Buenos Aires between June 2011 and April 2014 was analyzed on an intention to treat basis. Patient demographics, clinical characteristics (body mass index, anesthesiological risk score, Charlson comorbidity index, preoperative chemotherapy), tumor type, surgical details, FLR hypertrophy, postoperative liver function, postoperative complications, length of hospital stay and survival were analyzed.
Regarding the surgical procedure, during the first stage a complete tumor resection (clean-up) of the FLR is performed if bilateral disease was present, either trough anatomical or atypical resections. Subsequently, the portal vein of the diseased hemi-liver (DH) is divided and either total (up to the inferior vena cava) or partial (up to the middle hepatic vein) parenchymal transection using the Cavitron Ultrasonic Surgical Aspirator (CUSA; Valley Lab, Boulder, CO, USA) is carried out. At the end of the first stage, the DH is either wrapped in a plastic bag or a plastic sheath placed between the cut surfaces. Once volumetric CT analysis demonstrated enough FLR hypertrophy and provided the patient is in good condition, the second stage is carried out the next available operative day resecting the DH. The type of liver resections performed were defined using the Brisbane 2000 nomenclature.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALPPS group | – | Procedure: ALPPSPatients with small future liver remnant who are operated with the "Associating Liver Partition and Portal vein ligation for Staged hepatectomy" approach |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High-Volume University Hospital population
Key inclusion criteria (2 listed)
- Patients with marginally resectable or primarily non-resectable locally advanced liver tumors
- Insufficient FLR either in volume or quality
Key exclusion criteria (4 listed)
- Unresectable liver metastases in the future liver remnant or unresectable extrahepatic metastases
- Severe portal hypertension
- High anesthesiological risk
- Unresectable primary tumor
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 |
|---|---|---|
| ALPPSAssociating Liver Partition and Portal vein ligation for Staged hepatectomy | Procedure or surgery | ALPPS group |
Primary outcome
Safety of the procedure defined as the incidence of postoperative complications and mortality
Time frame: within the first 90 days after the first stage
Ocurrence of any postoperative complication or mortality considering the Dindo-Clavien classification of surgical complications
Feasibility of the procedure defined as percentage of patients that complete both surgical stages.
Time frame: within 4 months after the first stage
Percentage of patients that finally arrive to the 2nd stage of the ALPPS approach
4 secondary outcomes
Efficacy of the procedure defiend as the percentage of patients who achieve a sufficient future liver remnant hypertrophy
Time frame: within 10 days after the first stage
Disease-free survival and overall survival
Time frame: 1 and 2 years
Risk factors for morbidity
Time frame: within 3 month after the first stage
Risk factors for a reduced kinetic growth rate of the future liver remnant (<35 cc/day)
Time frame: within 3 months after the first stage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Background: PubMed 21475004Agrawal S, Belghiti J. Oncologic resection for malignant tumors of the liver. Ann Surg. 2011 Apr;253(4):656-65. doi: 10.1097/SLA.0b013e3181fc08ca.
- Background: PubMed 17429086Clavien PA, Petrowsky H, DeOliveira ML, Graf R. Strategies for safer liver surgery and partial liver transplantation. N Engl J Med. 2007 Apr 12;356(15):1545-59. doi: 10.1056/NEJMra065156. No abstract available.
- Background: PubMed 24159597Mise Y, Sakamoto Y, Ishizawa T, Kaneko J, Aoki T, Hasegawa K, Sugawara Y, Kokudo N. A worldwide survey of the current daily practice in liver surgery. Liver Cancer. 2013 Jan;2(1):55-66. doi: 10.1159/000346225.
- Background: PubMed 22330038Schnitzbauer AA, Lang SA, Goessmann H, Nadalin S, Baumgart J, Farkas SA, Fichtner-Feigl S, Lorf T, Goralcyk A, Horbelt R, Kroemer A, Loss M, Rummele P, Scherer MN, Padberg W, Konigsrainer A, Lang H, Obed A, Schlitt HJ. Right portal vein ligation combined with in situ splitting induces rapid left lateral liver lobe hypertrophy enabling 2-staged extended right hepatic resection in small-for-size settings. Ann Surg. 2012 Mar;255(3):405-14. doi: 10.1097/SLA.0b013e31824856f5.
- Background: PubMed 22330039de Santibanes E, Clavien PA. Playing Play-Doh to prevent postoperative liver failure: the "ALPPS" approach. Ann Surg. 2012 Mar;255(3):415-7. doi: 10.1097/SLA.0b013e318248577d. No abstract available.
- Background: PubMed 23632095Shindoh J, Vauthey JN, Zimmitti G, Curley SA, Huang SY, Mahvash A, Gupta S, Wallace MJ, Aloia TA. Analysis of the efficacy of portal vein embolization for patients with extensive liver malignancy and very low future liver remnant volume, including a comparison with the associating liver partition with portal vein ligation for staged hepatectomy approach. J Am Coll Surg. 2013 Jul;217(1):126-33; discussion 133-4. doi: 10.1016/j.jamcollsurg.2013.03.004. Epub 2013 Apr 28.
- Background: PubMed 24748319Schadde E, Ardiles V, Slankamenac K, Tschuor C, Sergeant G, Amacker N, Baumgart J, Croome K, Hernandez-Alejandro R, Lang H, de Santibanes E, Clavien PA. ALPPS offers a better chance of complete resection in patients with primarily unresectable liver tumors compared with conventional-staged hepatectomies: results of a multicenter analysis. World J Surg. 2014 Jun;38(6):1510-9. doi: 10.1007/s00268-014-2513-3.
- Background: PubMed 23702869Torres OJ, Fernandes Ede S, Oliveira CV, Lima CX, Waechter FL, Moraes-Junior JM, Linhares MM, Pinto RD, Herman P, Machado MA. Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS): the Brazilian experience. Arq Bras Cir Dig. 2013 Jan-Mar;26(1):40-3. doi: 10.1590/s0102-67202013000100009. English, Portuguese.
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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.
Eduardo de Santibañes, MD, PhD study director
General Surgery Service, Hospital Italiano de Buenos Aires. Argentina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Malignant Liver Disease, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. 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: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety of the procedure defined as the incidence of postoperative complications and mortality (time frame: within the first 90 days after the first stage). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02164292, which also lists 8 linked publications.
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 13 Aug 2019.