Long-term Results of Comprehensive AE Management

NCT02509884 | Completed

• 1 other identifier: 166/13
• Study Type: observational
• Target: 312
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comprehensive diagnosis and treatment of Alveolar Echinococcosis : A single-center, long-term observational study of 312 Patients in Germany. Human alveolar echinococcosis (AE) is the most Iethal human helminthic infection and is one of the 17 neglected tropical diseases prioritized by the World Health Organization (WHO). Its incidence is low in endemic regions of Central and Western Europe (0.03-0.05/100,000), but morbidity and treatment costs are high. In this observational study, the investigators assessed the severity of the disease using the PNM staging system and report on the long-term results of specific AE therapy in an interdisciplinary team of clinicians.

Conditions

Alveolar Echinococcosis

Keywords

Alveolar Echinococcosis (AE); Echinococcus multilocularis; antiparasitic treatment; surgery; classification; staging; prospective cohort study

Outcome Measures

Primary Outcomes (3)

• Overall survival after diagnosis,

  Survival was estimated by the Kaplan Meier method.

  inclusion January 1992-December 2011; end of follow-up December 2012 .Inclusion January 1992-December 1999 (series A).Inclusion January 2000- December 2011 (series B)

• Relapse after surgery or progression of remaining liver lesions in size or new lesions in other organs

  Parameters with an assumed influence on the time until relapse or progress of the parasitic lesions entered Kaplan Meier survival analysis and Cox proportional hazard regression model analysis, respectively, and hazard ratios (HR) with corresponding 95% confidence intervals (CI) were calculated.

  inclusion January 1992-December 2011; end of follow-up December 2012.Inclusion January 1992-December 1999 (series A).Inclusion January 2000- December 2011 (series B)

• Time to relapse or progress

  inclusion January 1992-December 2011; end of follow-up December 2012.Inclusion January 1992-December 1999 (series A).Inclusion January 2000- December 2011 (series B)

Secondary Outcomes (4)

• Symptoms and comorbidities

  inclusion January 1992-December 2011; end of follow-up December 2012. Inclusion January 1992-December 1999 (series A).Inclusion January 2000- December 2011 (series B)

• Medical treatment and side effects

  inclusion January 1992-December 2011; end of follow-up December 2012Inclusion January 1992-December 1999 (series A).Inclusion January 2000- December 2011 (series B)

• Treatment interruption ant potential cure

  inclusion January 1992-December 2011; end of follow-up December 2012.Inclusion January 1992-December 1999 (series A).Inclusion January 2000- December 2011 (series B)

• Surgical and interventional treatment

  inclusion January 1992-December 2011; end of follow-up December 2012.Inclusion January 1992-December 1999 (series A).Inclusion January 2000- December 2011 (series B)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with AE seen at the specialized treatment unit in Ulm between January 1992 and December 2011 were included in the database. Follow-up ended on 31.12.2012. Cases were defined according to the likelihood of diagnosis as a "possible", "probable", or "confirmed case"

You may qualify if:

• All patients with AE seen at the specialized treatment unit in Ulm between January 1992 and December 2011.

Sponsors & Collaborators

• University of Ulm: lead

Related Publications (2)

• Kern P, Wen H, Sato N, Vuitton DA, Gruener B, Shao Y, Delabrousse E, Kratzer W, Bresson-Hadni S. WHO classification of alveolar echinococcosis: principles and application. Parasitol Int. 2006;55 Suppl:S283-7. doi: 10.1016/j.parint.2005.11.041. Epub 2005 Dec 15.

  PMID: 16343985 BACKGROUND

• Brunetti E, Kern P, Vuitton DA; Writing Panel for the WHO-IWGE. Expert consensus for the diagnosis and treatment of cystic and alveolar echinococcosis in humans. Acta Trop. 2010 Apr;114(1):1-16. doi: 10.1016/j.actatropica.2009.11.001. Epub 2009 Nov 30.

  PMID: 19931502 BACKGROUND

MeSH Terms

Conditions

Alveolar echinococcosis; Echinococcosis

Condition Hierarchy (Ancestors)

Cestode Infections; Helminthiasis; Parasitic Diseases; Infections

Study Officials

• Beate Grüner, MD

  University of Ulm

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beate Grüner, MD

Study Record Dates

• First Submitted: July 12, 2015
• First Posted: July 28, 2015
• Study Start: January 1, 1992
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: July 28, 2015

Record last verified: 2015-07