Skip to main content
OpenTrials
Completed

NCT Number: NCT05678218

Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hilar Cholangiocarcinoma Adenocarcinoma Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Carcinoma Cholangiocarcinoma Common Bile Duct Diseases Common Bile Duct Neoplasms Digestive System Diseases Digestive System Neoplasms Intrahepatic Cholangiocarcinoma Klatskin Tumor Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Ghent, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Ultrasound registration

Procedure

Registration of all findings during Endoscopic Ultrasound

Primary outcomes

  1. Lymph nodes identified compared to imaging

    Time frame: Through study completion, max 1 year

    Number of lymph nodes correctly identified based on visualization and biopsy in comparison to cross-sectional imaging

  2. Lymph nodes identified compared to surgery

    Time frame: 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 outcomes

  1. Endoscopic Ultrasound (EUS)-characteristics predictive for malignant involvement of lymph nodes

    Time frame: 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.

  2. Different locations of positive lymph nodes and its effect on survival

    Time frame: Through study completion, max 1 year

    Days of survival after EUS and surgery, stratified per cholangiocarcinoma type, as well as lymph node locations

  3. Short term and long term complications of the EUS (+/- tissue acquisition) procedure for patients with pCCA and iCCA

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma - a Registration Study

Acronym: POELH-II

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 10, 2023
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.