Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma

Last updated: August 22, 2024
Sponsor: Erasmus Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Biliary Tract Cancer

Gall Bladder Cancer

Liver Cancer

Treatment

Endoscopic Ultrasound registration

Clinical Study ID

NCT05678218
MEC-2022-0402
  • Ages 18-110
  • All Genders

Study Summary

The goal of this observational cohort study is to assess the yield of preoperative endoscopic ultrasound focussed on lymph nodes in patients with presumed resectable perihilar (pCCA), intrahepatic (iCCA) or mid-common bile duct (CBD) cholangiocarcinoma. The main questions it aims to answer is:

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

  2. Characteristics during endoscopic ultrasound of lymph nodes associated with malignancy

Eligibility Criteria

Inclusion

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 onHarmonisation/Good Clinical Practice guidelines, and national/local regulations AND

  • Age > 18 years.

Exclusion

Exclusion Criteria:

  • Patients with a history of treated CCA

  • Patients with CCA for which a pancreatoduodenectomy is indicated, based oncross-sectional imaging

  • Patients with a history of treated liver malignancy

  • Patients with a contra-indication for EUS-tissue acquisition (f.e. uncorrectablecoagulopathy or platelet disorder), in line with current clinical practice

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Endoscopic Ultrasound registration
Phase:
Study Start date:
September 05, 2022
Estimated Completion Date:
February 01, 2026

Connect with a study center

  • University Hospital of Ghent

    Ghent,
    Belgium

    Active - Recruiting

  • Maastricht UMC+

    Maastricht, Limburg 6229 HX
    Netherlands

    Active - Recruiting

  • Amsterdam University Medical Center

    Amsterdam, Noord-Holland
    Netherlands

    Active - Recruiting

  • Leiden University Medical Center

    Leiden, Zuid-Holland 2333 ZA
    Netherlands

    Active - Recruiting

  • Erasmus University Medical Center

    Rotterdam, Zuid-Holland 3015 CN
    Netherlands

    Active - Recruiting

  • University Medical Center Groningen

    Groningen, 9713GZ
    Netherlands

    Active - Recruiting

  • University Medical Center Utrecht

    Utrecht, 3508 GA
    Netherlands

    Active - Recruiting

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