NCT07161869

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hilar Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma (Icc)
• Cholangiocarcinoma
• Perihilar Cholangiocarcinoma
• Common Bile Duct Neoplasms
• Adenocarcinoma of Biliary Tract

Interventions

Type	Name	Description
PROCEDURE	Registration of all findings during preoperative Endoscopic Ultrasound	Using the improved POELH-III EUS format

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-10-01
• Completion: 2028-11-01
• First posted: 2025-09-09
• Last updated: 2025-09-09

Locations

1 site across 1 country: Netherlands