Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma

Study Overview
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Brief Summary
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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 acquisition Characteristics during endoscopic ultrasound of lymph nodes associated with malignancy

Official Title
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Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma - a Registration Study

Conditions
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Hilar Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Common Bile Duct Neoplasms, Cholangiocarcinoma, Adenocarcinoma

Intervention / Treatment
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* Procedure: Endoscopic Ultrasound registration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Presumed resectable perihilar, intrahepatic or mid-common bile duct (CBD) cholangiocarcinoma<br> | Procedure: Endoscopic Ultrasound registration<br>* Registration of all findings during Endoscopic Ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymph nodes identified compared to imaging | Number of lymph nodes correctly identified based on visualization and biopsy in comparison to cross-sectional imaging | 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 | Through study completion, max 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | Through study completion, max 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic Ultrasound, Fine Needle Aspiration, Fine Needle Biopsy, Lymph Node, Adenocarcinoma