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Diagnostic Efficacy of EUS-FNA/B Versus ERCP With or Without POCS-TB in Patients With Suspected Hilar Cholangiocarcinoma

Diagnostic Efficacy of EUS-FNA/B Versus ERCP With or Without POCS-TB in Patients With Suspected Hilar Cholangiocarcinoma

Recruiting
18-90 years
All
Phase N/A

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Overview

This is an observational study with a prospective cohort design. This study enrolled patients with suspected hilar cholangiocarcinoma on imaging. This study aims to evaluate the histopathological diagnostic efficacy of endoscopic ultrasound-guided fine-needle aspiration/biopsy (EUS-FNA/B) and endoscopic retrograde cholangiopancreatography (ERCP) with or without peroral cholangioscopy targeted biopsy (POCS-TB) in patients with suspected hilar cholangiocarcinoma. In addition, the incidence of complications was compared between the EUS-FNA/B and ERCP with or without POCS-TB. The impact of the histopathological diagnosis on survival outcomes in patients with suspected hilar cholangiocarcinoma was evaluated.

Eligibility

Inclusion Criteria:

  1. 18-90 years old;
  2. Newly diagnosed patients with suspected hilar cholangiocarcinoma on imaging examination

Exclusion Criteria:

  1. Patients with a definite diagnosis of cholangiocarcinoma by imaging (enhanced CT, MRI, or MRCP) and surgical candidacy within 3 months;
  2. Patients scheduled for liver transplantation;
  3. patients with previous gastroduodenal diversion or biliary surgery;
  4. Patients with hilar bile duct stenosis caused by tumor or lesion outside the bile duct;
  5. Pregnant or lactating women;
  6. Patients who cannot tolerate intravenous general anesthesia due to various reasons;
  7. Patients with severe coagulation dysfunction, or patients who cannot stop antiplatelet/anticoagulant therapy for a short time and are unsuitable for low molecular weight heparin replacement therapy;
  8. Patients who refused to sign informed consent.

Study details
    Klatskin Tumor
    Cholangiocarcinoma
    Biopsy
    Fine-Needle
    Endoscopic Retrograde Cholangiopancreatography

NCT05993429

Qilu Hospital of Shandong University

4 May 2024

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