Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT05678218
Status:
COMPLETED
Last Update Posted:
2025-08-08
First Post:
2022-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma
Sponsor:
Erasmus Medical Center
Organization:
Study Overview
Official Title:
Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma - a Registration Study
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POELH-II
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: