Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma (POELH-III)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorErasmus Medical Center

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

Treatment groups

250 Participants
are divided into 1 treatment group

Sponsors and collaborators