Clinical trial NCT01924741: Registry of Major Liver Resections Including ALPPS and Other Liver Resections in Two Stages
Official title: International Registry to Assess Outcomes of Major Liver Resections Requiring Two Interventions Including the New Operation Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy (ALPPS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Neoplasms
Liver Regeneration
Keywords: Liver neoplasms
Liver regeneration
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-08-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primarily non-resectable liver tumors

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.

Detailed description: The ALPPS registry is accessible online through the data portal www.allps.net. Registered members recieve access through a member ID and password. Data submission is supported by the SECUTRIAL software, supported by the Clinical Trials center of the University of Zurich.

All data submitted are anonymized before entry through the SECUTRIAL Software. Administration of the registry data is performed through the Department of Visceral and Transplantation Surgery in the University Hospital Zurich and the Clinical Trials Center of the University of Zurich, Switzerland, in collaboration with the Italian Hospital in Buenoas Aires, Argentina.

A Scientific Committee has been appointed to give approval for any data analysis. Any participating center may apply for data analysis.

Particiating International Centers have responsibility for the validity of the data submitted and the respective local institutional review procedures.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* No exclusion criteria apply for a registry

Primary outcomes:
measure: Morbidity and mortality (peripoerative)
timeFrame: 3 months
Secondary outcomes:
measure: Long term survival
timeFrame: 5 years
measure: Perioperative liver and renal function
timeFrame: 5 days
measure: Disease specific recurrence/failure to cure
timeFrame: 5 years
measure: Liver Growth as assessed by imaging-based volumetry
timeFrame: between stage 1 and stage 2 (1-12 weeks)
Other outcomes:
measure: Inclusion criteria by registry participants
timeFrame: at enrollment
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Pierre Alain Clavien, Prof, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.