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: 1. The number of patients precluded from surgical work-up due to positive regional or extraregional lymph nodes identified by endoscopic ultrasound guided tissue acquisition 2. Characteristics during endoscopic ultrasound of lymph nodes associated with malignancy
Study Type
OBSERVATIONAL
Enrollment
245
Registration of all findings during Endoscopic Ultrasound
University Hospital of Ghent
Ghent, Belgium
Maastricht UMC+
Maastricht, Limburg, Netherlands
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands
Leiden University Medical Center
Leiden, South Holland, Netherlands
Erasmus University Medical Center
Rotterdam, South Holland, Netherlands
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands
Lymph nodes identified compared to imaging
Number of lymph nodes correctly identified based on visualization and biopsy in comparison to cross-sectional imaging
Time frame: Through study completion, max 1 year
Lymph nodes identified compared to surgery
Number of lymph nodes correctly identified based on visualization and biopsy in comparison to surgery, in the patients in which this is performed
Time frame: Through study completion, max 1 year
Endoscopic Ultrasound (EUS)-characteristics predictive for malignant involvement of lymph nodes
Rate of malignant lymph nodes in which a certain characteristic is present (f.e. shape of the lymph node), in comparison to benign lymph nodes.
Time frame: Through study completion, max 1 year
Different locations of positive lymph nodes and its effect on survival
Days of survival after EUS and surgery, stratified per cholangiocarcinoma type, as well as lymph node locations
Time frame: Through study completion, max 1 year
Short term and long term complications of the EUS (+/- tissue acquisition) procedure for patients with pCCA and iCCA
Short term (\<30 days) * Sedation related: consisting of cardiovascular-related complications (cardiac arrhythmias, myocardial ischemia/infarction), respiratory- related complications (respiratory depression, hypoxia, airway obstruction, pulmonary aspiration of gastric contents) and allergic reactions. * Hemorrhage (outside peritoneal wall): defined as clinical evidence of bleeding with a hemoglobin drop of \>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 Long term (\>30 days) \- Tumor seeding; defined as proof of carcinoma in the biopsy tract during follow-up or at autopsy
Time frame: Through study completion, max 1 year
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