Which biopsy is best for hilar cancer? new study aims to find out

NCT ID NCT05993429

Diagnosis Sponsor: Qilu Hospital of Shandong University Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study compares two ways to get tissue samples from a suspected hilar bile duct cancer: one using an endoscope with ultrasound guidance (EUS-FNA/B) and another using a scope to look directly into the bile ducts (ERCP with or without a special camera). Researchers will check which method is more accurate, safer, and more cost-effective. The study involves 200 adults with suspected hilar cholangiocarcinoma based on imaging.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to: If successful, this study could help doctors choose the best biopsy method for diagnosing hilar bile duct cancer, improving accuracy and reducing complications.
What could go wrong: This is an observational study, not a treatment trial, so it won't directly improve patient outcomes. Results may vary based on individual patient factors and expert judgment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

200 people

The number who actually took part.

Started

Aug 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with suspected hilar cholangiocarcinoma who were considered suitable for obtaining histopathological diagnosis by EUS-FNA/B or ERCP with or without POCS-TB by experts

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma hilar cholangiocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biopsy, fine-needle Cholangiocarcinoma Endoscopic retrograde cholangiopancreatography Klatskin tumor

Which biopsy is best for hilar cancer? new study aims to find out

What the study statuses mean