Adenocarcinoma, Cholangiocarcinoma, Common Bile Duct Neoplasms, Hilar Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma
Conditions
Keywords
Endoscopic Ultrasound, Fine Needle Aspiration, Fine Needle Biopsy, Lymph Node, Adenocarcinoma
Brief 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: 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
Interventions
PROCEDUREEndoscopic Ultrasound registration
Registration of all findings during Endoscopic Ultrasound
Sponsors
Erasmus Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lymph nodes identified compared to imaging | Through study completion, max 1 year | Number of lymph nodes correctly identified based on visualization and biopsy in comparison to cross-sectional imaging |
| Lymph nodes identified compared to surgery | Through study completion, max 1 year | Number of lymph nodes correctly identified based on visualization and biopsy in comparison to surgery, in the patients in which this is performed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic Ultrasound (EUS)-characteristics predictive for malignant involvement of lymph nodes | Through study completion, max 1 year | 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. |
| Different locations of positive lymph nodes and its effect on survival | Through study completion, max 1 year | Days of survival after EUS and surgery, stratified per cholangiocarcinoma type, as well as lymph node locations |
| Short term and long term complications of the EUS (+/- tissue acquisition) procedure for patients with pCCA and iCCA | Through study completion, max 1 year | 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 |
Countries
Belgium, Netherlands
Outcome results
None listed