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

Qilu Hospital of Shandong University200 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Klatskin Tumor Cholangiocarcinoma Biopsy, Fine-Needle Endoscopic Retrograde Cholangiopancreatography

Interventions

The appropriate sampling approach was selected as EUS-FNA/B or ERCP with or without POCS-TB based on experts' overall evaluation. This study will compare the histopathological diagnosis of the selected sampling method with the final diagnosis.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. ≥ 18 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.

Outcomes

Primary Outcomes

The diagnostic value of EUS-FNA/B versus ERCP with or without POCS-TB in diagnosing hilar cholangiocarcinoma

The diagnostic value was assessed by sensitivity, specificity, accuracy, and positive and negative predictive values.