Trial Information

Cytological Evaluation of Biliary Epithelium After Previous Endoscopic Sphincterotomy for Benign Disease

Informed consent will be obtained from all patients. ERCP will be conducted at the
Endoscopic Unit of Aretaieion University Hospital and Tzaneio General Hospital, Athens,
Greece. Pethidine, midazolam or propofol will be used for patient sedation. ERCP will be
conducted with the use of a side viewing endoscope. After catheterization of the common bile
duct through the previous sphincterotomy, cellular material will be obtained with the use of
an endoscopic brush from the bile ducts. With the same way, brush cytology will be performed
in the control group after performing ES.

Material obtained from each patient will be smeared on five glass slides. Four slides will
be fixed with ethanol solution 95% and the fifth will be air dried. The brush will be fixed
in suitable liquid for performing liquid phase cytology. Immunocytology with
immunofluorescence p-53 antibody will be performed in samples with hyperplasia, dysplasia or
atypia. The cytology department of Tzaneio Hospital will conduct examination and evaluation
of all samples.

Samples based on their morphological characteristics will be classified in five categories:
a. inadequate sample (very small cell number, presence of blood, inadequate fixation) b.
negative for malignancy (adequate cell number with benign morphologic characteristics) c.
reactive with or without atypia (cells with reactive/proliferative or inflammatory
characteristics. Malignancy is rare but cannot be excluded) d. suspicious for malignancy e.
positive for malignancy [21,22].

Examination and evaluation of the specimens will be done by two specialized cytologists,
separately, in order to achieve more objective results.