About this trial
In the POELH-II trial (Clinicaltrials.gov ID NCT05678218) patients with presumed resectable perihilar (pCCA), intrahepatic (iCCA) or mid-common bile duct (CBD) cholangiocarcinoma had the outcomes of their preoperative endoscopic ultrasound (EUS) registered. This EUS procedure was done systematically, targeting lymph nodes (LNs) with the aim to identify LN metastases preoperatively.
The goal of this follow-up observational cohort study (POELH-III) is to assess the yield of preoperative EUS, with an improved EUS approach. The EUS protocol as used in the POELH-II trial was improved based on preliminary results of the POELH-II trial. The main questions it aims to answer is:
\- The number of patients precluded from surgical work-up due to positive regional or extraregional LNs identified by EUS guided tissue acquisition
Eligibility criteria
Qualifiers
Presumed resectable pCCA OR
Presumed resectable iCCA OR
Presumed resectable mid-common bile duct CCA OR
Presumed unresectable pCCA worked-up for Liver Transplantation AND
Disqualifiers
Patients with a history of treated CCA
Patients with CCA for which a pancreatoduodenectomy is indicated, based on cross-sectional imaging
Patients with a history of treated liver malignancy
Patients with a contra-indication for EUS-tissue acquisition (f.e. uncorrectable coagulopathy or platelet disorder), in line with current clinical practice
Trial design
Treatments tested in this trial
- Registration of all findings during preoperative Endoscopic Ultrasound