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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Presumed resectable perihilar, intrahepatic or mid-common bile duct (CBD) cholangiocarcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Ultrasound registration | Procedure | Registration of all findings during Endoscopic Ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Different locations of positive lymph nodes and its effect on survival |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Ghent | Ghent | Belgium | ||||
| Maastricht UMC+ |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40645595 | Background | de 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. | |
| 39184062 | Background | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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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 | Short term (<30 days)
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 |
| Maastricht |
| Limburg |
| 6229 HX |
| Netherlands |
| Amsterdam University Medical Center | Amsterdam | North Holland | Netherlands |
| University Medical Center Groningen | Groningen | Provincie Groningen | 9713GZ | Netherlands |
| Leiden University Medical Center | Leiden | South Holland | 2333 ZA | Netherlands |
| Erasmus University Medical Center | Rotterdam | South Holland | 3015 CN | Netherlands |
| University Medical Center Utrecht | Utrecht | Utrecht | 3508 GA | Netherlands |
| 31860935 | Background | 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. |
| 18061597 | Background | 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. |
| 32277489 | Background | 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. |
| 36741342 | Background | 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. |
| 37890597 | Background | 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. |
| ID | Term |
|---|---|
| D018285 | Klatskin Tumor |
| D018281 | Cholangiocarcinoma |
| D003138 | Common Bile Duct Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001650 | Bile Duct Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D003137 | Common Bile Duct Diseases |
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