bile duct cancer cholangiocarcinoma
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Patients with resectable EC undergoing ERCP to achieve pre-operative biliary decompression of the FRL - (Suspicion of) EC is based on clinical assessment and imaging results (MRI/MRCP and CT), histological confirmation is not obligatory. - Resectability of the tumor was evaluated at the regional multidisciplinary team meeting - Biliary stenosis located distally, or perihilar according to Bismuth classification based on imaging results (MRI/MRCP/CT) - Informed consent - Age >= 18 years
Exclusion criteria
Exclusion criteria: • Intrahepatic cholangiocarcinoma • Irresectable tumor • Previous treatment with a biliary plastic endoprothesis or self-expandable metal stent (SEMS) • Previous treatment with a percutaneous transhepatic biliary drain • Patients with expected very limited survival (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical feasibility to perform cholangioscopy in EC, defined as the technical success to advance the Spyglass DS II cholangioscope through the malignant stricture into the intended (segmental) bile duct system(s), to assess ductal tumor borders optically and to obtain mapping biopsies of the locations of interest depending on the predetermined resection lines. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall diagnostic value of optical cholangioscopic assessment combined with biopsies of bile duct locations at interest outside the predetermined resection lines. 2. Diagnostic value of optical cholangioscopic assessment or biopsies alone. 3.Adverse outcomes after cholangioscopy defined by any cholangioscopy-related AE or mortality within 30 days. The AE will be recorded according the ASGE lexicon. | — |
Countries
Netherlands
Outcome results
None listed