Feasibility of Cryobiopsy from the Bile Duct - CRYLEO

Inclusion Criteria:

• Suspicion of any neoplastic alterations in the bile duct system or other indicationfor biopsy sampling in the bile duct

• A percutaneous drainage or an access by means of percutaneous transhepaticcholangiodrainage (PTCD) has been previously established independent from studyparticipation, without adverse events

• Patient is at least 18 years of age

• According to physicians' assessment, patient is able to follow study protocol or isable to understand the nature, objectives, benefits, implications, risks andinconveniences of the clinical investigation, able to comply with study requirementsand understand and independently sign the Informed Consent Form

Exclusion Criteria:

• • Presence of hereditary bleeding disorder, e.g. hemophilia A or hemophilia B

• Severe impairment of partial thromboplastin time (PTT) of >80s; Internationalnormalized ratio (INR) >3; platelet count <50,000 /nl

• Dual antiplatelet therapy (change to aspirin monotherapy is no exclusioncriterion)

• Current use of systemic anticoagulation or antiplatelet therapy without theability to hold therapy for the recommended amount of time prior to an invasiveprocedure (aspirin monotherapy is no exclusion criterion) Patient isparticipating in another clinical study pregnant or breast-feeding or intendingto get pregnant during the study