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

Shandong University

Status: Completed

Conditions: Klatskin Tumor; Biopsy, Fine-Needle; Endoscopic Retrograde Cholangiopancreatography; Cholangiocarcinoma

Treatments: Diagnostic Test: The sampling method selected in patients with suspected hilar cholangiocarcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT05993429

2023SDU-QILU-3

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

EUS-FNA/B group; ERCP with or without POCS-TB group

Description:

EUS-FNA/B group: Patients with suspected hilar cholangiocarcinoma who were considered suitable for obtaining histopathological diagnosis by EUS-FNA/B by experts

Treatment:

Diagnostic Test: The sampling method selected in patients with suspected hilar cholangiocarcinoma

ERCP with or without POCS-TB group

Description:

ERCP with or without POCS-TB group: Patients with suspected hilar cholangiocarcinoma who were considered suitable for obtaining histopathological diagnosis by ERCP with or without POCS-TB by experts

Treatment:

Diagnostic Test: The sampling method selected in patients with suspected hilar cholangiocarcinoma