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

N/AUnknownNCT01924741

University of Zurich500 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Liver Neoplasms Liver Regeneration

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 .

Time frame: 3 months

Secondary Outcomes

Long term survival

Outcome variables include long term survival after 3, 6, 12, 18 and 24 month, survival status after 3, 4, and 5 years. If the patient is still alive the data about hepatic recurrence and systemic recurrence will be collected. If there is a recurrence the type of treatment will be recorded.

Time frame: 5 years

Perioperative liver and renal function

Outcome variables include liver and renal function after surgery. INR and Total bilirubin as well as creatinine prior to surgery and 5 days after stage 1 and five days after stage 2 are recorded and commonly accepted citeria for postoperative liver and postoperative renal failure are used to assess these 2 types of complications.

Time frame: 5 days

Disease specific recurrence/failure to cure

Outcome variables include disease specific failure to cure (to completely resect) or disease specific recurrence after 3, 6, 12, 18 and 24 month, survival status after 3, 4, and 5 years. If there is a failure to cure or recurrence, the type of treatment will be recorded.

Time frame: 5 years

Liver Growth as assessed by imaging-based volumetry

Outcomes variables include Liver Growth as assessed by imaging-based volumetry between stage 1 and stage 2 (1-12 weeks)as assessed either by computer tomography or magnetic resonance based volumetry

Time frame: between stage 1 and stage 2 (1-12 weeks)