Biliary Candidiasis - Optimization of Diagnostics and Therapy
Condition: Secondary Cholangitis; Bile Duct Strictures of Unknown Origin
MeSH terms: Candidiasis; Cholangitis
Study type: Observational

Summary: 
      Biliary obstruction and cholangitis are common problems in gastroenterology and need specific
      therapeutic interventions. Besides a variety of potential causes, infections of the biliary
      tract with Candida and other fungal species have increasingly been reported in the last few
      years. Especially interesting is the question, if patients with positive fungal cultures of
      bile samples should be treated or not and under which circumstances. The primary aim of the
      present study is to evaluate wether positive fungal cultures of bile samples indicate fungal
      infection of the biliary tract, rather colonization or simply contamination during endoscopic
      retrograde cholangiopancreatography (ERCP) procedure.
    

Detailed description: 
      Background:

      Biliary obstruction and cholangitis are common problems in gastroenterology and need specific
      therapeutic interventions. Besides a variety of potential causes, infections of the biliary
      tract with Candida and other fungal species have increasingly been reported in the last few
      years [1-6]. Fungal infections can even lead to common bile duct (CBD) obstruction, as
      previously reported [7]. Because of the difficulty of gaining bile samples, little is known
      about the microbial flora of the bile. In a first prospective, observational study, 123
      consecutive patients undergoing ERCP for various indications were screened for fungal species
      [8]. According to this data Candida species may be very frequently be detected in the bile
      (54/123 patients, 44 % of the cases). As significant risk factors immunosuppression and
      long-term antibiotic therapy were identified. The main issue in this context is whether
      positive diagnostic findings represent fungal infection or fungal colonization. Especially
      interesting is the question, if patients with positive fungal cultures of bile samples should
      be treated or not and under which circumstances.

      Study Aim:

      The primary aim of the present study is to evaluate wether positive fungal cultures of bile
      samples indicate fungal infection of the biliary tract, rather colonization or simply
      contamination during ERCP procedure. In addition to mycological analysis of bile samples,
      tissue samples of the common bile duct are collected to confirm fungal invasion.

      Study design:

      The study is designed as a single-center, non-randomized, observational study. The conducting
      center is the University Hospital of Muenster, Department of Medicine B, Gastroenterology.
      The examinations are performed by two experienced gastroenterologists (D. D., H. U.).

      Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure:

      ERCP is performed using a conventional duodenoscope as described in the literature. To
      exclude contamination artefacts, smears of the endoscope working channel (elevator) will be
      taken before and after the examination. Furthermore buccal smears and stool samples will be
      taken to get an impression of the individual transient flora. Endoscopic transpapillary bile
      duct biopsy for diagnosing an invasive fungal infection will be performed. Transpapillary
      biopsies as confirmed by the present literature cause no increased risk for
      post-interventional bleeding and infection [9-12]. Additionally with routinely taken blood
      samples (hemoglobin and lipase), candida-antigen-serology and blood-cultures will be gained.

      Ethics:

      The study protocol conformed to the ethical guidelines of the 1975 Declaration of Helsinki
      and was a priori approved by the local ethics committee of the University of Muenster.

      Statistical methods:

      The data will be analyzed using standard statistical methods. As observational study, no
      power-analysis will reasonable - nevertheless data will be shown with confidence interval.
      All statistical analyses will be performed in cooperation with the Department of Medical
      Informatics and Biomathematics.
    

Intervention name(s): ERCP
Intervention type(s): Procedure
Intervention description(s): endoscopic retrograde cholangiopancreatography transpapillary biopsies
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients referred to a hospital of maximum care.
      
Biospecimen description: 
      bile samples, buccal smears, stool samples, blood samples, transpapillary biopsies (bile
      duct)