Multimodality Preoperative Evaluation of lymph nodes of perihilar cholangiocarcinoma – a pilot study

The survival of patients with perihilar cholangiocarcinoma (CCA) is limited, as pCCA is often recognized in a relatively late stadium, making it ineligible for surgical resection, which is the only potentially curative treatment. The resectability of pCCA depends on local tumor extension, vascular involvement and presence of metastatic disease. Both distant and lymph node metastases are determining the choice of treatment and the prognosis, since the prognosis of patients with N2 lymph nodes or distant metastases is not altered by loco-regional surgery, and therefore surgical resection is contraindicated. Moreover, survival for patients with positive N1 lymph nodes is very poor and the small oncological advantage may not justify the surgical risk in some of these patients. Therefore, correct lymph node assessment is crucial, which is often difficult to determine preoperatively with cross-sectional imaging. Endoscopic Ultrasound (EUS) with Fine Needle Aspiration (FNA) or Fine Needle Biopsy (FNB) of the lymph nodes might be a more accurate method to assess lymph node staging, which might lead to a better preoperative shared decision making, since patients might be spared from invasive surgical treatments. Therefore, the aim of this pilot study is to evaluate whether EUS with FNA or FNB of the lymph nodes (EUS-FNA/FNB) has added value for proper diagnosis of lymph node metastases in patients with presumed resectable pCCA and to evaluate its effect on clinical decision-making. In addition, the accuracy of lymph node assessment with EUS-FNA/FNB and its impact on clinical decision making will be compared to current state-of-the-art cross-sectional imaging (CT scan and Pet-MRI) and complications of EUS-FNA/FNB will be evaluated.

EUS-FNA/FNB can more accurately detect regional and non-regional lymph node metastasis than cross-sectional imaging and has a significant impact on clinical decision making.

Before EUS (imaging), EUS procedure and surgery (if performed)

EUS, conform current clinical practice, to assess all lymph nodes through a systematic survey. FNA or FNB will be performed in any lymph node that is indicated suspicious.