Registry of Major Liver Resections Including ALPPS and Other Liver Resections in Two Stages

NCT01924741 | Unknown

• 1 other identifier: ALPPS registry
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Recently a new method of induce similar hypertrophy in the liver as is observed after hepatectomy has been described and was given the eponym "ALLPS". "ALPPS" stands for Associating Liver Partition with Portal Vein Ligation for Staged Hepatectomy (ALPPS). Since the procedure is used worldwide this international registry was created to enable tracking of cases performed worldwide for safety and outcomes and innovations by the groups involved as well as allows a non-randomized comparison to the conventional methods of portal vein occlusion.

Conditions

Liver Neoplasms; Liver Regeneration

Keywords

Liver neoplasms; Liver regeneration

Outcome Measures

Primary Outcomes (1)

• Morbidity and mortality (peripoerative)

  Primary outcome variablesis perioperative mortality and complications and survival status after 3 months. Data will be entered following the widely accepted Clavien-Dindo classification system .

  3 months

Secondary Outcomes (4)

• Long term survival

  5 years

• Perioperative liver and renal function

  5 days

• Disease specific recurrence/failure to cure

  5 years

• Liver Growth as assessed by imaging-based volumetry

  between stage 1 and stage 2 (1-12 weeks)

Other Outcomes (1)

• Inclusion criteria by registry participants

  at enrollment

Study Arms (1)

ALPPS

ALPPS is the most recent modification of the techniques developed for Two-stage hepatectomies. ALPPS allows to remove an extensive part of the liver in two steps. In the first step the liver parenchyma is transected along the intended line of resection and the future liver remnant cleaned by partial resections from all tumor tissue in the case of bilobar tumors. To this a portal ligation of the larger liver lobe that will have to be removed is added. After a waiting period of 1-2 weeks the second step is performed in which the deportalized liver is removed to render the patient completely tumor-free. (Ann Surg 2012; 255(3):405-14.)

Procedure: ALPPS

Interventions

ALPPS PROCEDURE

Other procedures related to ALPPS like banding of the parechyma with portal vein ligation etc.

Also known as: In-situ split hepatectomy

ALPPS

Eligibility Criteria

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

Study Population

Patients with primarily non-resectable liver tumors

You may qualify if:

• All Patients who undergo the new ALPPS procedure
• Patients undergoing any other modification of ALPPS like portal vein embolization (PVE) or banding of the liver with portal vein ligation or embolisation or other liver resection in two stages resembling ALPPS\_
• Male and Female patients 18 years to no limit
• Prior registering the data, patient was informed and did not object to the use of his/her anonymized medical data in this registry

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (2)

• 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

• Reese T, Fard-Aghaie MH, Makridis G, Kantas A, Wagner KC, Malago M, Robles-Campos R, Hernandez-Alejandro R, de Santibanes E, Clavien PA, Petrowsky H, Linecker M, Oldhafer KJ. Renal Impairment Is Associated with Reduced Outcome After Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy. J Gastrointest Surg. 2020 Nov;24(11):2500-2507. doi: 10.1007/s11605-019-04419-2. Epub 2019 Nov 19.

  PMID: 31745902 DERIVED

Related Links

• Click here to receive more information about ALPPS registry and studies

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Pierre Alain Clavien, Prof, MD, PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: August 16, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: July 31, 2014

Record last verified: 2014-07

Locations

CH (1)