Trial Title:
Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma
NCT ID:
NCT05678218
Condition:
Hilar Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma
Common Bile Duct Neoplasms
Cholangiocarcinoma
Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Cholangiocarcinoma
Klatskin Tumor
Bile Duct Neoplasms
Common Bile Duct Neoplasms
Conditions: Keywords:
Endoscopic Ultrasound
Fine Needle Aspiration
Fine Needle Biopsy
Lymph Node
Adenocarcinoma
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Endoscopic Ultrasound registration
Description:
Registration of all findings during Endoscopic Ultrasound
Arm group label:
Presumed resectable perihilar, intrahepatic or mid-common bile duct (CBD) cholangiocarcinoma
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
Criteria for eligibility:
Study pop:
Patients with suspected iCCA or pCCA who have a presumed resectable carcinoma will be
invited to participate. Patients with CCA distal from the cystic junction but proximal
from the pancreatic body are eligible for inclusions as well, as treatment is similar to
Bismuth I pCCA. In other words, all patients with CCA that is not distal CCA for which a
pancreato-duodenectomy is indicated, are eligible for inclusion. Also patients with
presumed unresectable pCCA who are worked-up for liver transplantation are invited to
participate. At time of inclusion a definitive diagnosis of iCCA/pCCA is not obligatory,
since definitive diagnosis of CCA is sometimes confirmed during the preoperative EUS
through EUS guided biopsy of the mass. The probable diagnosis of iCCA/pCCA and the
suspected resectability will be established during the multidisciplinary meeting, based
on clinical symptoms, cross-sectional imaging, endoscopy and laboratory tests.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
110 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital of Ghent
Address:
City:
Ghent
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Pieter Hindryckx, MD, PhD
Email:
pieter.hindryckx@uzgent.be
Contact backup:
Last name:
Suzane Ribeiro, MD, PhD
Email:
Suzane.RibeiroMoura@uzgent.be
Facility:
Name:
Maastricht UMC+
Address:
City:
Maastricht
Zip:
6229 HX
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Jan Werner Poley, MD, PhD
Email:
jan.werner.poley@mumc.nl
Facility:
Name:
Amsterdam University Medical Center
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Rogier P. Voermans, MD PhD
Email:
r.p.voermans@amsterdamumc.nl
Contact backup:
Last name:
Roy L. van Wanrooij, MD PhD
Email:
rl.vanwanrooij@amsterdamumc.nl
Facility:
Name:
Leiden University Medical Center
Address:
City:
Leiden
Zip:
2333 ZA
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Akin Inderson, MD
Email:
a.inderson@lumc.nl
Contact backup:
Last name:
Jeanin van Hooft, MD, PhD
Email:
j.e.van_Hooft@lumc.nl
Facility:
Name:
Erasmus University Medical Center
Address:
City:
Rotterdam
Zip:
3015 CN
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Lydi van Driel, MD, PhD
Email:
l.m.j.w.vandriel@erasmusmc.nl
Contact backup:
Last name:
David de Jong, BSc
Email:
d.m.dejong@erasmusmc.nl
Facility:
Name:
University Medical Center Groningen
Address:
City:
Groningen
Zip:
9713GZ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Frederike GI van Vilsteren, MD, PhD
Email:
f.g.i.van.vilsteren@umcg.nl
Contact backup:
Last name:
Wouter Nagengast, MD, PhD
Email:
w.b.nagengast@umcg.nl
Facility:
Name:
University Medical Center Utrecht
Address:
City:
Utrecht
Zip:
3508 GA
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Joep de Bruijne, MD, PhD
Email:
J.deBruijne-7@umcutrecht.nl
Contact backup:
Last name:
Leon Moons, MD, PhD
Email:
L.M.G.Moons@umcutrecht.nl
Start date:
September 5, 2022
Completion date:
February 1, 2026
Lead sponsor:
Agency:
Erasmus Medical Center
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05678218
