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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Liver Neoplasms, Liver Regeneration

Intervention / Treatment
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* Procedure: ALPPS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ALPPS<br>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<br>* Other procedures related to ALPPS like banding of the parechyma with portal vein ligation etc.<br>* Other names: In-situ split hepatectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | between stage 1 and stage 2 (1-12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver neoplasms, Liver regeneration