ALPPS: Safety, Feasibility and Efficacy at a Single Center

NCT02164292 | Completed

• 1 other identifier: 1942
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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

Locally Advanced Malignant Liver Disease

Keywords

Liver tumor; ALPPS; Two-stage hepatectomy; Morbidity; Hypertrophy

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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

  within 10 days after the first stage

• Disease-free survival and overall survival

  1 and 2 years

• Risk factors for morbidity

  within 3 month after the first stage

• Risk factors for a reduced kinetic growth rate of the future liver remnant (<35 cc/day)

  within 3 months after the first stage

Study Arms (1)

ALPPS group

Patients with small future liver remnant who are operated with the "Associating Liver Partition and Portal vein ligation for Staged hepatectomy" approach

Procedure: ALPPS

Interventions

ALPPS PROCEDURE

Associating Liver Partition and Portal vein ligation for Staged hepatectomy

ALPPS group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

High-Volume University Hospital population

You may qualify if:

• Patients with marginally resectable or primarily non-resectable locally advanced liver tumors
• Insufficient FLR either in volume or quality

You may not qualify if:

• Unresectable liver metastases in the future liver remnant or unresectable extrahepatic metastases
• Severe portal hypertension
• High anesthesiological risk
• Unresectable primary tumor

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1181ACH, Argentina

Location

Related Publications (8)

• 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.

  PMID: 21475004 BACKGROUND

• Clavien 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 BACKGROUND

• Mise 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 BACKGROUND

• Schnitzbauer 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 BACKGROUND

• de 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 BACKGROUND

• Shindoh 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 BACKGROUND

• Schadde 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.

  PMID: 24748319 BACKGROUND

• Torres 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.

  PMID: 23702869 BACKGROUND

Related Links

• Worldwide registry of Associating Liver Partition and Portal vein Ligation for Staged hepatectomy (ALPPS)

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hypertrophy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Eduardo de Santibañes, MD, PhD

  General Surgery Service, Hospital Italiano de Buenos Aires. Argentina

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 16, 2014
• Study Start: June 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

AR (1)