Hilar CholangiocarcinomaPOELH-IIINCT07161869
Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma (POELH-III)
An observational study of Hilar Cholangiocarcinoma and Intrahepatic Cholangiocarcinoma (Icc), run by Erasmus Medical Center at 6 sites in Netherlands.
Trial summary
In the POELH-II trial (Clinicaltrials.gov ID NCT05678218) patients with presumed resectable perihilar (pCCA), intrahepatic (iCCA) or mid-common bile duct (CBD) cholangiocarcinoma had the outcomes of their preoperative endoscopic ultrasound (EUS) registered. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hilar Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma (Icc), Cholangiocarcinoma
- What is being tested?
- Registration of all findings during preoperative Endoscopic Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 6 sitesNetherlands
- Study dates
- 5 Feb 2026to 1 Nov 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
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 years and older
- 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
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
David M de Jong, MD MSc contact
6 sites in 1 country
Netherlands6 sites, 6 recruiting
- Not yet recruiting
Amsterdam University Medical Center
Amsterdam
Rogier P Voermans, MD PhD
- Not yet recruiting
University Medical Center Groningen
Groningen
Frederike GI van Vilsteren, MD PhD
Wouter Nagengast, MD PhD
- Not yet recruiting
Leiden University Medical Center
Leiden
Akin Inderson, MD
- Not yet recruiting
Maastricht University Medical Center+
Maastricht
Jan Werner Poley, MD PhD
Maxime Dewulf, MD PhD
- Recruiting
Erasmus MC University Medical Center
Rotterdam, South Holland, 3015 CN
Lydi MJW van Driel, MD PhD
Marco J Bruno, MD PhD
- Not yet recruiting
University Medical Center Utrecht
Utrecht
Joep de Bruijne, MD PhD
About this study
Official title: Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma by Endoscopic Ultrasound (POELH-III)
In the POELH-II trial (Clinicaltrials.gov ID NCT05678218) patients with presumed resectable perihilar (pCCA), intrahepatic (iCCA) or mid-common bile duct (CBD) cholangiocarcinoma had the outcomes of their preoperative endoscopic ultrasound (EUS) registered. This EUS procedure was done systematically, targeting lymph nodes (LNs) with the aim to identify LN metastases preoperatively.
The goal of this follow-up observational cohort study (POELH-III) is to assess the yield of preoperative EUS, with an improved EUS approach. The EUS protocol as used in the POELH-II trial was improved based on preliminary results of the POELH-II trial. The main questions it aims to answer is:
- The number of patients precluded from surgical work-up due to positive regional or extraregional LNs identified by EUS guided tissue acquisition
- Conditions
- Hilar Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma (Icc), Cholangiocarcinoma, Perihilar Cholangiocarcinoma, Common Bile Duct Neoplasms, Adenocarcinoma of Biliary Tract
- Being tested
- Registration of all findings during preoperative Endoscopic Ultrasound
- Keywords
- poelh, EUS, Lymph node, cholangiocarcinoma, biliary tract cancer
- Medical subject headings
- Klatskin Tumor, Cholangiocarcinoma, Cirrhosis, Familial, with Pulmonary Hypertension, Common Bile Duct Neoplasms, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Registration of all findings during preoperative Endoscopic UltrasoundProcedure or surgery
Using the improved POELH-III EUS format
| Study group | Role | What they receive |
|---|---|---|
| Presumed resectable perihilar, intrahepatic or mid-common bile duct (CBD) cholangiocarcinoma | Not described Receives: Procedure: Registration of all findings during preoperative Endoscopic Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients precluded from surgical work-up due to positive regional or extraregional lymph nodes identified by endoscopic ultrasound guided tissue acquisition
Measured: Through study completion, max 1 year
Secondary outcomes (1)
Short term and long term complications of the EUS (+/- tissue acquisition) procedure
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.
- First posted9 Sep 2025
- Study start5 Feb 2026
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hilar CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 250 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydi M.J.W. van Driel, MD, MSc, PhD, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161869
- Sponsor's protocol ID
- MEC-2022-0402.1
- Acronym
- POELH-III
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Publications
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 39184062Larghi 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 32277489Malikowski 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 31860935Gleeson 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 18061597de 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 37890597de 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 36741342de 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