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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-01

Study Completion Date

2028-11-01

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Presumed resectable perihilar, intrahepatic or mid-common bile duct (CBD) cholangiocarcinoma

Registration of all findings during preoperative Endoscopic Ultrasound

Intervention Type PROCEDURE

Using the improved POELH-III EUS format

Interventions

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Registration of all findings during preoperative Endoscopic Ultrasound

Using the improved POELH-III EUS format

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No