Clinical trial · Observational
ALPPS: Safety, Feasibility and Efficacy at a Single Center
Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS): Safety, Feasibility and Efficacy at a Single Center
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Malignant Liver Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALPPS | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ALPPS group
- description
- Patients with small future liver remnant who are operated with the "Associating Liver Partition and Portal vein ligation for Staged hepatectomy" approach
- interventionNames
- Procedure: ALPPS
Primary outcomes (2)
- measure
- Safety of the procedure defined as the incidence of postoperative complications and mortality
- timeFrame
- within the first 90 days after the first stage
- description
- Ocurrence of any postoperative complication or mortality considering the Dindo-Clavien classification of surgical complications
- measure
- Feasibility of the procedure defined as percentage of patients that complete both surgical stages.
- timeFrame
- within 4 months after the first stage
- description
- Percentage of patients that finally arrive to the 2nd stage of the ALPPS approach
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with marginally resectable or primarily non-resectable locally advanced liver tumors * Insufficient FLR either in volume or quality Exclusion Criteria: * Unresectable liver metastases in the future liver remnant or unresectable extrahepatic metastases * Severe portal hypertension * High anesthesiological risk * Unresectable primary tumor
References
Publications (8)
- BACKGROUNDAgrawal S, Belghiti J. Oncologic resection for malignant tumors of the liver. Ann Surg. 2011 Apr;253(4):656-65. doi: 10.1097/SLA.0b013e3181fc08ca. PMID 21475004
- BACKGROUNDClavien 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. PMID 17429086
- BACKGROUNDMise 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. PMID 24159597
- BACKGROUNDSchnitzbauer 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. PMID 22330038
- BACKGROUNDde 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. PMID 22330039
- BACKGROUNDShindoh 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. PMID 23632095