Alveolar Echinococcosis Clinical Trial
Official title:
Comprehensive Diagnosis and Treatment of Alveolar Echinococcosis : A Single-center, Longterm Observational Study of 312 Patients in Germany
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.
All patients with Alveolar Echinococcosis (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 to the likelihood of diagnosis as a "possible", "probable" or
"confirmed" case . Diagnosis of AE was based on clinical presentation, epidemiological
history, pathognomonic imaging findings, specific laboratory results, such as
immunodiagnosis or histopathological findings in resected/ biopsied specimens, and/or
detection of nucleic acid sequences in such specimens. The location of the larval lesions
and its spread at diagnosis was documented using the PNM classification. Treatment with
benzimidazoles was followed the WHO-IWGE recommendations. Treatment efficacy was monitored
by US examination and FDG-PET scan or MRI. To categorize each case at each visit the terms
"cured", "stable" or "progressive" were used. Patients' data was assessed at each visit;
missing information was obtained from hospital records or the family doctor. Names were
anonymized and data was stored in a Microsoft Excel database. Statistics were done with SAS
version 9.3.
The data were stratified into series A containing diagnoses until December 1999 and series B
from January 2000 onwards. This separation was chosen as patient admissions to the clinic
rose almost 3-fold in 2000 when notification of AE became mandatory in Germany. It can be
assumed that series B better represents AE patient characteristics, disease manifestation
and comprehensive management; series A includes case histories with favorable prognoses at
the time of diagnosis while optimal treatment for AE was still unavailable.
Outcome parameters for this study population were: overall survival after diagnosis, relapse
after surgery or progression of remaining liver lesions in size or new lesions in other
organs, and time to relapse or progress. Survival was estimated by the Kaplan Meier method.
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. Logistic regression was used to identify factors which may predict a
successful treatment interruption using the odds ratio (OR) as an appropriate outcome
parameter.
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Time Perspective: Retrospective
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