Perihilar cholangiocarcinoma
Conditions
Interventions
EUS, conform current clinical practice, to assess all lymph nodes through a systematic survey. FNA or FNB will be performed in any lymph node that is indicated suspicious.
Sponsors
None
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a patient must meet all three following criteria: • Presumed resectable pCCA. • Written informed consent must be given according to ICH/GCP, and national/local regulations. • Age > 18 years.
Exclusion criteria
Exclusion criteria: A patient who meets any of the following criteria will be excluded from participation in this study: • Patients with a history of treated pCCA • Patients with a history of treated liver malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -To evaluate the accuracy of EUS-FNA/FNB in regional and non-regional lymph nodes, compared to cross-sectional imaging and surgery, defined as: oNumber of lymph nodes correctly identified by EUS-FNA-FNB in comparison to surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| - To evaluate the impact of EUS-FNA/FNB of both regional and non-regional lymph nodes on clinical decision making in patients with presumed resectable pCCA, defined as: o Number of patients in whom surgery is withheld due to positive lymph nodes detected with EUS-FNA/FNB - To evaluate the number of patients with positive lymph nodes detected with CT and Pet-MRI compared to EUS-FNA/FNB and to surgery when performed, defined as: o Number of lymph nodes correctly identified by CT and Pet-MRI in comparison to EUS-FNA/FNB or surgery - To evaluate the different locations of positive lymph nodes and its effect on survival, defined as: o Days of survival after EUS and surgery per N0, N1, N2 or M status. - To identify short term and long term complications of EUS-FNA/FNB in detecting lymph nodes in patients with pCCA, defined as: o Short term (3g/dl with the need for resuscitation or additional intervention ? Perforation: defined as evidence of air or luminal contents outside the gastro-intestinal tract together with clinical symptoms, requiring percutaneous drainage or surgery ? Mortality o Long term (>30 days) ? Tumor seeding; defined as proof of carcinoma in the biopsy tract during follow-up or at autopsy | — |
Contacts
Public ContactDavid de Jong
Erasmus University MC
Outcome results
None listed