Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma

Cholangiocarcinoma Clinical Trial

— POELH-II  

Official title:

Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma - a Registration Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05678218
• Other study ID #: MEC-2022-0402
• Status: Recruiting
• Start date: September 5, 2022
• Est. completion date: February 1, 2026

Study information

• Verified date: April 2024
• Source: Erasmus Medical Center
• Contact: David de Jong, BSc
• Phone: 010 704 0704
• Email: d.m.dejong[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Bile Duct Neoplasms
• Cholangiocarcinoma
• Common Bile Duct Neoplasms
• Hilar Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma
• Klatskin Tumor

Intervention

Procedure:
• Endoscopic Ultrasound registration
Registration of all findings during Endoscopic Ultrasound

Locations

Country	Name	City	State
Belgium	University Hospital of Ghent	Ghent
Netherlands	Amsterdam University Medical Center	Amsterdam	Noord-Holland
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Leiden University Medical Center	Leiden	Zuid-Holland
Netherlands	Maastricht UMC+	Maastricht	Limburg
Netherlands	Erasmus University Medical Center	Rotterdam	Zuid-Holland
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Countries where clinical trial is conducted

Belgium,  Netherlands, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Through study completion, max 1 year
Secondary	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	Through study completion, max 1 year
Secondary	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	Through study completion, max 1 year