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

Not yet recruiting

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

• Registration Number: NCT07161869
• Lead Sponsor: Erasmus Medical Center

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-28
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-08
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09
• Study Start: 2025-10-01
• Primary Completion: 2028-10-01
• Study Completion: 2028-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of patients precluded from surgical work-up due to positive regional or extraregional lymph nodes identified by endoscopic ultrasound guided tissue acquisition	Through study completion, max 1 year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Erasmus MC University Medical Center; 🇳🇱 Rotterdam, South Holland, Netherlands