Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma

Recruiting

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

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Presumed resectable perihilar, intrahepatic or mid-common bile duct (CBD) cholangiocarcinoma	Endoscopic Ultrasound registration	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Locations (7): University Hospital of Ghent
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Ghent, Belgium
Amsterdam University Medical Center
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Amsterdam, Noord-Holland, Netherlands
Leiden University Medical Center
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Leiden, Zuid-Holland, Netherlands
Erasmus University Medical Center
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Rotterdam, Zuid-Holland, Netherlands
University Medical Center Groningen
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Groningen, Netherlands
Maastricht UMC+
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Maastricht, Limburg, Netherlands
University Medical Center Utrecht
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Utrecht, Netherlands