Comparing two techniques for obtaining tissue samples from pancreatic lesions
Multicentered Prospective Randomized Controlled Trial On Contrast-Enhanced Harmonic Endoscopic Ultrasound (CH_EUS) Vs Conventional EUS-Guided Fine Needle Biopsy (FNB) For Solid Pancreatic Lesions
This study is testing whether a new way of taking tissue samples from pancreatic lesions is better than the standard method for helping doctors get accurate results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT04841616 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the diagnostic performance of contrast-enhanced endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) compared to conventional EUS-FNB for solid pancreatic lesions. The study will involve patients referred for tissue acquisition of pancreatic lesions larger than 1 cm, utilizing advanced techniques such as macroscopic on-site evaluation to assess specimen adequacy. The goal is to determine which method provides better diagnostic accuracy and specimen quality for further histological analysis.
Who should consider this trial
Good fit: Ideal candidates are individuals referred for EUS-guided tissue acquisition of solid pancreatic lesions greater than 1 cm.
Not a fit: Patients with coagulopathy, altered anatomy, contraindications for conscious sedation, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy for pancreatic lesions, enabling better treatment decisions for patients.
How similar studies have performed: Previous studies have shown promising results with similar techniques, although this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * referred for EUS-guided tissue acquisition for solid pancreatic lesions greater than 1cm in the largest diameter. Exclusion Criteria: * with coagulopathy, altered anatomy, contraindications for conscious sedation, pregnancy * who cannot provide informed consent.
Where this trial is running
Hong Kong
- Department of Surgery; The Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Ching Ning Chong — Cuhk
- Study coordinator: Ching Ning Chong
- Email: chongcn@surgery.cuhk.edu.hk
- Phone: 35051496
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.