Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT07161869
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-09
First Post:
2025-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma (POELH-III)
Sponsor:
Erasmus Medical Center
Organization:
Study Overview
Official Title:
Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma by Endoscopic Ultrasound (POELH-III)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
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-III
Brief Summary:
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
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
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?:
None
Is an FDA AA801 Violation?: