Long-term Results of Comprehensive AE Management

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

312 participants

Study Classification

OBSERVATIONAL

Study Start Date

1992-01-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Alveolar Echinococcosis: Parasite Viability and Innovative Markers for the Follow-up of Patients Treated With Albendazole

NCT02876146

Alveolar Echinococcosis

COMPLETED NA

Epi Cystic Hydatid Disease Peru

NCT00138346

E. Granulosus Cystic Hydatid d

COMPLETED

Evaluation of an AI-DP for STH Deworming Programs: a Study Protocol

NCT06055530

Soil Transmitted Helminths Schistosomiasis Mansoni

UNKNOWN

Evaluation of a New Multiplex Quantitative PCR Technique for the Diagnosis of Echinococcosis

NCT05824442

Echinococcosis Diagnosis

RECRUITING NA

Using Community-Based Volunteers to Reach Non-Enrolled School Aged Children Through Community-Directed Treatment of Schistosomiasis in School-Aged Children in Rural Northern Ghana

NCT00463931

Schistosomiasis Soil-Transmitted Helminthiasis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.