Preoperative Lymph Node Assessment in Cholangiocarcinoma using Endoscopic Ultrasound

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

POELH-III is an observational study that builds on POELH-II to evaluate an improved EUS approach for detecting lymph node metastases before surgery in patients with cholangiocarcinoma of the liver hilum, intrahepatic areas, or mid-common bile duct. They systematically register EUS findings and tissue acquisitions to determine how many patients are precluded from surgical work-up due to positive lymph nodes. The trial collects data from multiple centers under Erasmus Medical Center and collaborates to refine preoperative staging. Outcomes focus on yield of EUS-based LN detection and its impact on treatment planning, without intervening on patient management as part of the study.

Why it matters

Who can join: the full rules

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

Where it's running

• Erasmus MC University Medical Center
  Rotterdam, South Holland, Netherlands 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

Study contacts

• Study coordinator: Lydi M. J. W. van Driel, MD PhD
• Email: l.m.j.w.vandriel@erasmusmc.nl
• Phone: + 31 10 704 0704

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.