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Clinical Trials in the Netherlands / NCT07161869
Recruiting Observational

Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma (POELH-III)

NCT07161869 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Erasmus Medical Center
Phase
Observational
Started
2026-02-05
Last updated
2026-09-10

Condition(s) studied

Hilar CholangiocarcinomaIntrahepatic Cholangiocarcinoma (Icc)CholangiocarcinomaPerihilar CholangiocarcinomaCommon Bile Duct NeoplasmsAdenocarcinoma of Biliary Tract

Investigational drug(s) / intervention(s)

Registration of all findings during preoperative Endoscopic Ultrasound

Registration of all findings during preoperative Endoscopic Ultrasound: Using the improved POELH-III EUS format

Study summary

In the POELH-II trial (Clinicaltrials.gov ID NCT05678218) patients with presumed resectable perihilar (pCCA), intrahepatic (iCCA) or mid-common bile duct (CBD) cholangiocarcinoma had the outcomes of their preoperative endoscopic ultrasound (EUS) registered. This EUS procedure was done systematically, targeting lymph nodes (LNs) with the aim to identify LN metastases preoperatively.

The goal of this follow-up observational cohort study (POELH-III) is to assess the yield of preoperative EUS, with an improved EUS approach. The EUS protocol as used in the POELH-II trial was improved based on preliminary results of the POELH-II trial. The main questions it aims to answer is:

\- The number of patients precluded from surgical work-up due to positive regional or extraregional LNs identified by EUS guided tissue acquisition

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Erasmus MC University Medical Center Rotterdam South Holland Recruiting
Amsterdam University Medical Center Amsterdam Netherlands Not Yet Recruiting
University Medical Center Groningen Groningen Netherlands Not Yet Recruiting
Leiden University Medical Center Leiden Netherlands Not Yet Recruiting
Maastricht University Medical Center+ Maastricht Netherlands Not Yet Recruiting
University Medical Center Utrecht Utrecht Netherlands Not Yet Recruiting

More Erasmus Medical Center trials in the Netherlands

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Piezosurgery Versus Conventional Techniques in Orthognathic Surgery Starting soon
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Follow-up After Surgery for Colorectal Cancer Active, not recruiting
CAMK2-related Synapthopathies Natural History Study Recruiting

Other trials for the same condition

Neoadjuvant Gemcitabine and Cisplatin in Combination With Perioperative Pembrolizumab Versus Upfront Surgery for Patients With Primary Resectable and Borderline Resectable Perihilar and Distal Cholangiocarcinoma Recruiting
The Effect of [18F] F-FAPI PET-CT on Management in Patients With Proximal Cholangiocarcinoma Recruiting
An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma Active, not recruiting
Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer Active, not recruiting
The Dragon PLC Trial (DRAGON-PLC) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07161869 on ClinicalTrials.gov ↗ ← All trials in the Netherlands