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Hilar CholangiocarcinomaPOELH-IINCT05678218

Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma

An observational study of Hilar Cholangiocarcinoma and Intrahepatic Cholangiocarcinoma, run by Erasmus Medical Center at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 110 years
What is being tested?
Endoscopic Ultrasound registration
Type of treatment
Surgery or procedure
How many people
245 participants
Where
7 sitesin 2 countries
Study dates
5 Sep 2022to 1 Aug 2025
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 110 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

Netherlands6 sites

  • Amsterdam University Medical Center

    Amsterdam, North Holland

  • University Medical Center Groningen

    Groningen, Provincie Groningen, 9713GZ

  • Leiden University Medical Center

    Leiden, South Holland, 2333 ZA

  • Maastricht UMC+

    Maastricht, Limburg, 6229 HX

  • Erasmus University Medical Center

    Rotterdam, South Holland, 3015 CN

  • University Medical Center Utrecht

    Utrecht, Utrecht, 3508 GA

Other trials in Netherlands

Belgium1 site

  • University Hospital of Ghent

    Ghent

Other trials in Belgium

About this study

Official title: Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma - a Registration Study

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
Being tested
Endoscopic Ultrasound registration
Keywords
Endoscopic Ultrasound, Fine Needle Aspiration, Fine Needle Biopsy, Lymph Node, Adenocarcinoma
Medical subject headings
Klatskin Tumor, Cholangiocarcinoma, Common Bile Duct Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic Ultrasound registrationProcedure or surgery

    Registration of all findings during Endoscopic Ultrasound

Study groups in NCT05678218
Study groupRoleWhat they receive
Presumed resectable perihilar, intrahepatic or mid-common bile duct (CBD) cholangiocarcinomaNot described
Receives: Procedure: Endoscopic Ultrasound registration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lymph nodes identified compared to imaging

    Number of lymph nodes correctly identified based on visualization and biopsy in comparison to cross-sectional imaging

    Measured: Through study completion, max 1 year

  2. 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

    Measured: Through study completion, max 1 year

Secondary outcomes (3)

  1. Endoscopic Ultrasound (EUS)-characteristics predictive for malignant involvement of lymph nodes

    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.

    Measured: Through study completion, max 1 year

  2. Different locations of positive lymph nodes and its effect on survival

    Days of survival after EUS and surgery, stratified per cholangiocarcinoma type, as well as lymph node locations

    Measured: Through study completion, max 1 year

  3. Short term and long term complications of the EUS (+/- tissue acquisition) procedure for patients with pCCA and iCCA

    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

    Measured: Through study completion, max 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2023
  2. Study start5 Sep 2022
  3. Primary completion1 Jul 2025
  4. Study completion1 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
245 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05678218
Sponsor's protocol ID
MEC-2022-0402
Acronym
POELH-II
Status last verified
Jul 2025
First submitted
23 Dec 2022
Last updated
8 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Undecided

Publications

  • 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.

    PubMed 40645595

  • de 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.

    PubMed 39184062

  • Malikowski 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.

    PubMed 31860935

  • Gleeson 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.

    PubMed 18061597

  • Larghi 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.

    PubMed 32277489

  • de 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.

    PubMed 36741342

  • de 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.

    PubMed 37890597

Questions about this trial

What is this clinical trial studying?

An observational study of Hilar Cholangiocarcinoma and Intrahepatic Cholangiocarcinoma, run by Erasmus Medical Center at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lymph nodes identified compared to imaging (time frame: Through study completion, max 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05678218, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.

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