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

University of Zurich (UZH)

Status: Unknown

Conditions: Liver Neoplasms; Liver Regeneration

Treatments: Procedure: ALPPS

Study type: Observational

Funder types: Other

Identifiers

NCT01924741

ALPPS registry

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

ALPPS

Description:

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.)

Treatment:

Procedure: ALPPS