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NCT Number: NCT07161869

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

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

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Key information

Conditions

Hilar Cholangiocarcinoma Adenocarcinoma Adenocarcinoma of Biliary Tract Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Carcinoma Cholangiocarcinoma Cirrhosis, Familial, with Pulmonary Hypertension Common Bile Duct Diseases Common Bile Duct Neoplasms Digestive System Diseases Digestive System Neoplasms Intrahepatic Cholangiocarcinoma (Icc) Klatskin Tumor Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Perihilar Cholangiocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasmus MC University Medical Center

Rotterdam, South Holland, 3015 CN, Netherlands

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

Registration of all findings during preoperative Endoscopic Ultrasound

Procedure

Using the improved POELH-III EUS format

Primary outcomes

The number of patients precluded from surgical work-up due to positive regional or extraregional lymph nodes identified by endoscopic ultrasound guided tissue acquisition

Time frame: Through study completion, max 1 year

Secondary outcomes

Short term and long term complications of the EUS (+/- tissue acquisition) procedure

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lydi M. J. W. van Driel

CONTACT

[email protected]

+ 31 10 704 0704

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma by Endoscopic Ultrasound (POELH-III)

Acronym: POELH-III

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Sep 9, 2025
Registry last updated: Sep 9, 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.

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