Clinical trial NCT05678218: Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma
Official title: Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma - a Registration Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hilar Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma
Common Bile Duct Neoplasms
Cholangiocarcinoma
Adenocarcinoma
Keywords: Endoscopic Ultrasound
Fine Needle Aspiration
Fine Needle Biopsy
Lymph Node
Adenocarcinoma
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Lymph nodes identified compared to imaging
timeFrame: Through study completion, max 1 year
measure: Lymph nodes identified compared to surgery
timeFrame: Through study completion, max 1 year
Secondary outcomes:
measure: Endoscopic Ultrasound (EUS)-characteristics predictive for malignant involvement of lymph nodes
timeFrame: Through study completion, max 1 year
measure: Different locations of positive lymph nodes and its effect on survival
timeFrame: Through study completion, max 1 year
measure: Short term and long term complications of the EUS (+/- tissue acquisition) procedure for patients with pCCA and iCCA
timeFrame: Through study completion, max 1 year
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital of Ghent
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
state: Limburg
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
state: Noord-Holland
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
References:
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.
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.
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.
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.
citation: 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.