Evaluating diagnostic methods for suspected hilar cholangiocarcinoma
Diagnostic Efficacy of Endoscopic Ultrasound-guided Fine-needle Aspiration/Biopsy Versus Endoscopic Retrograde Cholangiopancreatography With or Without Peroral Cholangioscopy Targeted Biopsy for Suspected Hilar Cholangiocarcinoma: an Open Multicenter Prospective Study
Qilu Hospital of Shandong University · NCT05993429
This study is testing which method works better for diagnosing suspected hilar cholangiocarcinoma in patients by comparing a needle biopsy technique to a different type of imaging and biopsy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University (other) |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT05993429 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the diagnostic efficacy of endoscopic ultrasound-guided fine-needle aspiration/biopsy (EUS-FNA/B) compared to endoscopic retrograde cholangiopancreatography (ERCP) with or without peroral cholangioscopy targeted biopsy (POCS-TB) in patients suspected of having hilar cholangiocarcinoma. It will enroll patients based on imaging findings and evaluate the histopathological outcomes and complications associated with each method. Additionally, the study will analyze how the histopathological diagnosis impacts survival outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-90 with newly diagnosed suspected hilar cholangiocarcinoma based on imaging.
Not a fit: Patients with a confirmed diagnosis of cholangiocarcinoma or those scheduled for liver transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve diagnostic accuracy and treatment planning for patients with suspected hilar cholangiocarcinoma.
How similar studies have performed: Previous studies have shown varying success with similar diagnostic approaches, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jinan, Shandong
- Qilu Hospital of Shandong University — Jinan, Shandong, China (RECRUITING)
Study contacts
- Principal investigator: Ning Zhong, MD — Qilu Hospital of Shandong University
- Study coordinator: Zhen Li, MD
- Email: qilulizhen@sdu.edu.cn
- Phone: 18560086106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Klatskin Tumor, Cholangiocarcinoma, Biopsy, Fine-Needle, Endoscopic Retrograde Cholangiopancreatography