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

Erasmus University

Status: Not yet enrolling

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

Treatments: Procedure: Registration of all findings during preoperative Endoscopic Ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT07161869

MEC-2022-0402.1

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ 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

250 participants in 1 patient group

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

Treatment:

Procedure: Registration of all findings during preoperative Endoscopic Ultrasound