Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

245 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-05

Study Completion Date

2025-08-01

Brief Summary

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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:

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

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Detailed Description

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Conditions

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Hilar Cholangiocarcinoma Intrahepatic Cholangiocarcinoma Common Bile Duct Neoplasms Cholangiocarcinoma Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Presumed resectable perihilar, intrahepatic or mid-common bile duct (CBD) cholangiocarcinoma

Endoscopic Ultrasound registration

Intervention Type PROCEDURE

Registration of all findings during Endoscopic Ultrasound

Interventions

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Endoscopic Ultrasound registration

Registration of all findings during Endoscopic Ultrasound

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No