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

Liver Neoplasms Clinical Trial

— ALPPSREG  

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01924741
• Other study ID #: ALPPS registry
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 14, 2013
• Last updated: July 30, 2014
• Start date: August 2013
• Est. completion date: December 2016

Study information

• Verified date: July 2014
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Neoplasms
• Liver Regeneration

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Schnitzbauer AA, Lang SA, Goessmann H, Nadalin S, Baumgart J, Farkas SA, Fichtner-Feigl S, Lorf T, Goralcyk A, Hörbelt R, Kroemer A, Loss M, Rümmele P, Scherer MN, Padberg W, Königsrainer 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inclusion criteria by registry participants	The registry will evaluate the criteria used by study participants to include patients to the ALPPS procedure including tumor type, size, number extent, liver parechymal quality, starting volumes, resection volumes and specific methods of resection or sequneces of methods of resection used.	at enrollment	Yes
Primary	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	Yes
Secondary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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)	No

External Links

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