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

Recruitingn/aAges 18 Years - anyAllErasmus Medical Center
NCT07161869 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * Written informed consent must be given according to International Council on Harmonisation/Good Clinical Practice guidelines, and national/local regulations AND * Age \> 18 years. Exclusion Criteria: * 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
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What it tests

  • Registration of all findings during preoperative Endoscopic Ultrasound
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Where

6 sites
Erasmus MC University Medical Center
Rotterdam, Netherlands
Amsterdam University Medical Center
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Maastricht University Medical Center+
Maastricht, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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