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

Sponsor
Erasmus Medical Center
Study ID
NCT07161869
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Registration of all findings during preoperative Endoscopic Ultrasound — PROCEDURE
    Using the improved POELH-III EUS format

Study Details

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

Key Dates

First listed
Sep 9, 2025
Start date
Oct 1, 2025
Status verified
Aug 2025
Primary completion
Oct 1, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
250 participants (estimated)

Arms

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

Primary Outcome Measure

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 ]

Central Contacts

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