Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma (POELH-II)

August 5, 2025 updated by: Dr. L.M.J.W. (Lydi) van Driel, Erasmus Medical Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

245

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium
        • University Hospital of Ghent
  • Netherlands
      • Groningen, Netherlands, 9713GZ
        • University Medical Center Groningen
      • Utrecht, Netherlands, 3508 GA
        • University Medical Center Utrecht
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Maastricht UMC+
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands
        • Amsterdam University Medical Center
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands, 2333 ZA
        • Leiden University Medical Center
      • Rotterdam, Zuid-Holland, Netherlands, 3015 CN
        • Erasmus University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Presumed resectable perihilar, intrahepatic or mid-common bile duct (CBD) cholangiocarcinoma
Procedure: Endoscopic Ultrasound registration
Registration of all findings during Endoscopic Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lymph nodes identified compared to imaging
Time Frame: Through study completion, max 1 year
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
Time Frame: Through study completion, max 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic Ultrasound (EUS)-characteristics predictive for malignant involvement of lymph nodes
Time Frame: Through study completion, max 1 year
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.
Through study completion, max 1 year
Different locations of positive lymph nodes and its effect on survival
Time Frame: Through study completion, max 1 year
Days of survival after EUS and surgery, stratified per cholangiocarcinoma type, as well as lymph node locations
Through study completion, max 1 year
Short term and long term complications of the EUS (+/- tissue acquisition) procedure for patients with pCCA and iCCA
Time Frame: Through study completion, max 1 year

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
Through study completion, max 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2022

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

August 1, 2025

Study Registration Dates

First Submitted

December 23, 2022

First Submitted That Met QC Criteria

December 23, 2022

First Posted (Actual)

January 10, 2023

Study Record Updates

Last Update Posted (Actual)

August 8, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC-2022-0402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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