Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma

Recruiting

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

• Registration Number: NCT05678218
• Lead Sponsor: Erasmus Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Inclusion Criteria:<br><br> - Presumed resectable pCCA OR<br><br> - Presumed resectable iCCA OR<br><br> - Presumed resectable mid-common bile duct CCA OR<br><br> - Presumed unresectable pCCA worked-up for Liver Transplantation AND<br><br> - Written informed consent must be given according to International Council on<br> Harmonisation/Good Clinical Practice guidelines, and national/local regulations AND<br><br> - Age > 18 years.<br><br>Exclusion Criteria:<br><br> - Patients with a history of treated CCA<br><br> - Patients with CCA for which a pancreatoduodenectomy is indicated, based on<br> cross-sectional imaging<br><br> - Patients with a history of treated liver malignancy<br><br> - Patients with a contra-indication for EUS-tissue acquisition (f.e. uncorrectable<br> coagulopathy or platelet disorder), in line with current clinical practice

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational [Patient Registry]
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lymph nodes identified compared to imaging;Lymph nodes identified compared to surgery

Secondary Outcome Measures

Name	Time	Method
Endoscopic Ultrasound (EUS)-characteristics predictive for malignant involvement of lymph nodes;Different locations of positive lymph nodes and its effect on survival;Short term and long term complications of the EUS (+/- tissue acquisition) procedure for patients with pCCA and iCCA