POELH-II: Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma

Sponsor

Erasmus Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05678218

Collaborator

(none)

200

Enrollment

Location

40.9

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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:

The number of patients precluded from surgical work-up due to positive regional or extraregional lymph nodes identified by endoscopic ultrasound guided tissue acquisition
Characteristics during endoscopic ultrasound of lymph nodes associated with malignancy

Condition or Disease	Intervention/Treatment	Phase
Hilar Cholangiocarcinoma Intrahepatic Cholangiocarcinoma Common Bile Duct Neoplasms Cholangiocarcinoma Adenocarcinoma	Procedure: Endoscopic Ultrasound registration

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma - a Registration Study

Actual Study Start Date :

Sep 5, 2022

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Feb 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Presumed resectable perihilar, intrahepatic or mid-common bile duct (CBD) cholangiocarcinoma	Procedure: Endoscopic Ultrasound registration Registration of all findings during Endoscopic Ultrasound

Arm

Intervention/Treatment

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

Procedure: Endoscopic Ultrasound registration

Registration of all findings during Endoscopic Ultrasound

Outcome Measures

Primary Outcome Measures

Lymph nodes identified compared to imaging [Through study completion, max 1 year]
Number of lymph nodes correctly identified based on visualization and biopsy in comparison to cross-sectional imaging
Lymph nodes identified compared to surgery [Through study completion, max 1 year]
Number of lymph nodes correctly identified based on visualization and biopsy in comparison to surgery, in the patients in which this is performed

Secondary Outcome Measures

Endoscopic Ultrasound (EUS)-characteristics predictive for malignant involvement of lymph nodes [Through study completion, max 1 year]
Rate of malignant lymph nodes in which a certain characteristic is present (f.e. shape of the lymph node), in comparison to benign lymph nodes.
Different locations of positive lymph nodes and its effect on survival [Through study completion, max 1 year]
Days of survival after EUS and surgery, stratified per cholangiocarcinoma type, as well as lymph node locations
Short term and long term complications of the EUS (+/- tissue acquisition) procedure for patients with pCCA and iCCA [Through study completion, max 1 year]
Short term (<30 days) Sedation related: consisting of cardiovascular-related complications (cardiac arrhythmias, myocardial ischemia/infarction), respiratory- related complications (respiratory depression, hypoxia, airway obstruction, pulmonary aspiration of gastric contents) and allergic reactions. Hemorrhage (outside peritoneal wall): defined as clinical evidence of bleeding with a hemoglobin drop of >3g/dl with the need for resuscitation or additional intervention Perforation: defined as evidence of air or luminal contents outside the gastro-intestinal tract together with clinical symptoms, requiring percutaneous drainage or surgery Mortality Long term (>30 days) - Tumor seeding; defined as proof of carcinoma in the biopsy tract during follow-up or at autopsy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 110 Years

Sexes Eligible for Study:

All

Accepts 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