Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma
POELH-II
1 other identifier
observational
245
2 countries
7
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 5, 2022
CompletedFirst Submitted
Initial submission to the registry
December 23, 2022
CompletedFirst Posted
Study publicly available on registry
January 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedAugust 8, 2025
July 1, 2025
2.8 years
December 23, 2022
August 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Lymph nodes identified compared to imaging
Number of lymph nodes correctly identified based on visualization and biopsy in comparison to cross-sectional imaging
Through study completion, max 1 year
Lymph nodes identified compared to surgery
Number of lymph nodes correctly identified based on visualization and biopsy in comparison to surgery, in the patients in which this is performed
Through study completion, max 1 year
Secondary Outcomes (3)
Endoscopic Ultrasound (EUS)-characteristics predictive for malignant involvement of lymph nodes
Through study completion, max 1 year
Different locations of positive lymph nodes and its effect on survival
Through study completion, max 1 year
Short term and long term complications of the EUS (+/- tissue acquisition) procedure for patients with pCCA and iCCA
Through study completion, max 1 year
Study Arms (1)
Presumed resectable perihilar, intrahepatic or mid-common bile duct (CBD) cholangiocarcinoma
Interventions
Registration of all findings during Endoscopic Ultrasound
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University Hospital of Ghent
Ghent, Belgium
Maastricht UMC+
Maastricht, Limburg, 6229 HX, Netherlands
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands
University Medical Center Groningen
Groningen, Provincie Groningen, 9713GZ, Netherlands
Leiden University Medical Center
Leiden, South Holland, 2333 ZA, Netherlands
Erasmus University Medical Center
Rotterdam, South Holland, 3015 CN, Netherlands
University Medical Center Utrecht
Utrecht, Utrecht, 3508 GA, Netherlands
Related Publications (7)
de Jong DM, Lammers WJ, van Driel LMJW. Time to standardize preoperative EUS for lymph node staging in resectable extrahepatic cholangiocarcinoma. J Hepatol. 2025 Dec;83(6):e290-e291. doi: 10.1016/j.jhep.2025.06.031. Epub 2025 Jul 9. No abstract available.
PMID: 40645595BACKGROUNDde Jong DM, van de Vondervoort S, Dwarkasing RS, Thomeer MGJ, Doukas M, Voermans RP, Verdonk RC, Polak WG, de Jonge J, Bruno MJ, Van Driel LMJW, Groot Koerkamp B. Endoscopic ultrasound with tissue acquisition of lymph nodes in patients with potentially resectable intrahepatic cholangiocarcinoma. Endosc Int Open. 2024 Aug 23;12(8):E998-E1005. doi: 10.1055/a-2366-2592. eCollection 2024 Aug.
PMID: 39184062BACKGROUNDMalikowski T, Levy MJ, Gleeson FC, Storm AC, Vargas EJ, Topazian MD, Abu Dayyeh BK, Iyer PG, Rajan E, Gores GJ, Roberts LR, Chandrasekhara V. Endoscopic Ultrasound/Fine Needle Aspiration Is Effective for Lymph Node Staging in Patients With Cholangiocarcinoma. Hepatology. 2020 Sep;72(3):940-948. doi: 10.1002/hep.31077. Epub 2020 Jul 9.
PMID: 31860935BACKGROUNDGleeson FC, Rajan E, Levy MJ, Clain JE, Topazian MD, Harewood GC, Papachristou GI, Takahashi N, Rosen CB, Gores GJ. EUS-guided FNA of regional lymph nodes in patients with unresectable hilar cholangiocarcinoma. Gastrointest Endosc. 2008 Mar;67(3):438-43. doi: 10.1016/j.gie.2007.07.018. Epub 2007 Dec 3.
PMID: 18061597BACKGROUNDLarghi A, Rimbas M, Ardito F, Rizzatti G, Giuliante F. Letter to the Editor: EUS-FNA for Lymph Nodes Staging in Cholangiocarcinoma: Should It Become Standard of Care? Hepatology. 2020 Oct;72(4):1496. doi: 10.1002/hep.31266. No abstract available.
PMID: 32277489BACKGROUNDde Jong DM, van de Vondervoort S, Dwarkasing RS, Doukas M, Voermans RP, Verdonk RC, Polak WG, de Jonge J, Koerkamp BG, Bruno MJ, van Driel LMJW. Endoscopic ultrasound in patients with resectable perihilar cholangiocarcinoma: impact on clinical decision-making. Endosc Int Open. 2023 Feb 2;11(2):E162-E168. doi: 10.1055/a-2005-3679. eCollection 2023 Feb.
PMID: 36741342BACKGROUNDde Jong DM, den Hoed CM, Willemssen FEJA, Thomeer MGJ, Bruno MJ, Koerkamp BG, de Jonge J, Alwayn IPJ, van Hooft JE, Hoogwater F, van der Heide F, Inderson A, van Vilsteren FGI, van Driel LMJW. Impact of EUS in liver transplantation workup for patients with unresectable perihilar cholangiocarcinoma. Gastrointest Endosc. 2024 Apr;99(4):548-556. doi: 10.1016/j.gie.2023.10.047. Epub 2023 Oct 27.
PMID: 37890597BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Gastroenterologist, MD, PhD
Study Record Dates
First Submitted
December 23, 2022
First Posted
January 10, 2023
Study Start
September 5, 2022
Primary Completion
July 1, 2025
Study Completion
August 1, 2025
Last Updated
August 8, 2025
Record last verified: 2025-07