Evaluating lymph nodes in patients with cholangiocarcinoma before surgery
Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma - a Registration Study
Erasmus Medical Center · NCT05678218
This study is trying to see if a special ultrasound can help doctors find out if lymph nodes are cancerous in patients with cholangiocarcinoma before they have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center (other) |
| Locations | 7 sites (Ghent and 6 other locations) |
| Trial ID | NCT05678218 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to assess the effectiveness of preoperative endoscopic ultrasound in identifying lymph nodes in patients with presumed resectable cholangiocarcinoma. The study will focus on determining how many patients are deemed ineligible for surgery due to positive lymph nodes and will analyze the characteristics of these lymph nodes that are associated with malignancy. By utilizing endoscopic ultrasound guided tissue acquisition, the study seeks to improve surgical decision-making for patients with this type of cancer.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with presumed resectable perihilar, intrahepatic, or mid-common bile duct cholangiocarcinoma.
Not a fit: Patients with a history of treated cholangiocarcinoma or those requiring pancreatoduodenectomy based on imaging will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of surgical evaluations and improve outcomes for patients with cholangiocarcinoma.
How similar studies have performed: While similar approaches have been explored, this specific focus on lymph node evaluation in cholangiocarcinoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ghent and 6 other locations
- University Hospital of Ghent — Ghent, Belgium (RECRUITING)
- Maastricht UMC+ — Maastricht, Limburg, Netherlands (RECRUITING)
- Amsterdam University Medical Center — Amsterdam, Noord-Holland, Netherlands (RECRUITING)
- Leiden University Medical Center — Leiden, Zuid-Holland, Netherlands (RECRUITING)
- Erasmus University Medical Center — Rotterdam, Zuid-Holland, Netherlands (RECRUITING)
- University Medical Center Groningen — Groningen, Netherlands (RECRUITING)
- University Medical Center Utrecht — Utrecht, Netherlands (RECRUITING)
Study contacts
- Study coordinator: David de Jong, BSc
- Email: d.m.dejong@erasmusmc.nl
- Phone: 010 704 0704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hilar Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Common Bile Duct Neoplasms, Cholangiocarcinoma, Adenocarcinoma, Endoscopic Ultrasound, Fine Needle Aspiration, Fine Needle Biopsy