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Recruiting
NCT05678218
Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma
Conditions: Hilar Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Common Bile Duct Neoplasms, Cholangiocarcinoma, Adenocarcinoma
Sex: All
Ages: 18 Years – 110 Years
Enrollment: 200
Sponsor: Erasmus Medical Center
Location: Netherlands
Summary
The goal of this observational cohort study is to assess the yield of preoperative endoscopic ultrasound focussed on lymph nodes in patients with presumed resectable perihilar (pCCA), intrahepatic (iCCA) or mid-common bile duct (CBD) cholangiocarcinoma.
The main questions it aims to answer is:The number of patients precluded from surgical work-up due to positive regional or extraregional lymph nodes identified by endoscopic ultrasound guided tissue acquisitionCharacteristics during endoscopic ultrasound of lymph nodes associated with malignancy
Eligibility Criteria
Inclusion Criteria:Presumed resectable pCCA ORPresumed resectable iCCA ORPresumed resectable mid-common bile duct CCA ORPresumed unresectable pCCA worked-up for Liver Transplantation ANDWritten informed consent must be given according to International Council on Harmonisation/Good Clinical Practice guidelines, and national/local regulations ANDAge > 18 years.Exclusion Criteria:Patients with a history of treated CCAPatients with CCA for which a pancreatoduodenectomy is indicated, based on cross-sectional imagingPatients with a history of treated liver malignancyPatients with a contra-indication for EUS-tissue acquisition (f.e.
uncorrectable coagulopathy or platelet disorder), in line with current clinical practice
Source: ClinicalTrials.gov (NCT05678218). StuddyBuddy aggregates publicly available trial information.