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

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Aug 14, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at different methods for diagnosing a type of cancer called hilar cholangiocarcinoma, often referred to as Klatskin tumor. Researchers want to see how well two procedures—endoscopic ultrasound-guided fine-needle aspiration/biopsy (EUS-FNA/B) and endoscopic retrograde cholangiopancreatography (ERCP), with or without a special type of biopsy called peroral cholangioscopy targeted biopsy (POCS-TB)—work in finding this cancer in patients who are suspected to have it based on imaging tests. They will also compare any complications that might arise from these procedures and how accurate the tests are in predicting patient survival outcomes.

To be eligible for this study, participants need to be between 18 and 90 years old and have recently been diagnosed with suspected hilar cholangiocarcinoma based on imaging tests. However, certain patients, such as those with a confirmed diagnosis who are planning surgery soon, or those who cannot undergo specific medical procedures, may not qualify. If someone joins the study, they can expect to undergo one of these diagnostic procedures, and the research team will monitor their recovery and any side effects. Overall, the goal is to find the best way to diagnose this serious condition while keeping patients' safety in mind.

Gender

ALL

Eligibility criteria

• 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.