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

NCT ID: NCT01924741

Last Updated: 2014-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-12-31

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.

Conditions

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Liver Neoplasms Liver Regeneration

Keywords

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Liver neoplasms Liver regeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.)

ALPPS

Intervention Type PROCEDURE

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

Interventions

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ALPPS

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

Intervention Type PROCEDURE

Other Intervention Names

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In-situ split hepatectomy

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Alain Clavien, Prof, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

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University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 22330038 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31745902 (View on PubMed)

Related Links

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http://www.alpps.net

Click here to receive more information about ALPPS registry and studies

Other Identifiers

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ALPPS registry

Identifier Type: -

Identifier Source: org_study_id