CompletedNot Applicable

Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma

Belgium, Netherlands245 participantsStarted 2022-09-05

Plain-language 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

Who can participate

Age range18 Years – 110 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Lymph nodes identified compared to imaging

Timeframe: Through study completion, max 1 year

Lymph nodes identified compared to surgery

Timeframe: Through study completion, max 1 year

Trial details

NCT IDNCT05678218

SponsorErasmus Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-01