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

Erasmus University

Status: Enrolling

Conditions: Intrahepatic Cholangiocarcinoma; Cholangiocarcinoma; Hilar Cholangiocarcinoma; Adenocarcinoma; Common Bile Duct Neoplasms

Treatments: Procedure: Endoscopic Ultrasound registration

Study type: Observational

Funder types: Other

Identifiers

NCT05678218

MEC-2022-0402

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

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

Treatment:

Procedure: Endoscopic Ultrasound registration