Comparing motorized and standard fine needle biopsies for liver and pancreas diseases
Comparison Between a Novel Motorized EUS Guided Fine Needle Biopsy (FNB) With Standard Needle for Pancreatic and Liver Biopsies
NA · Instituto Ecuatoriano de Enfermedades Digestivas · NCT06298604
This study is testing whether a new motorized biopsy method can get better tissue samples from the liver and pancreas than the standard biopsy method for patients needing these tests.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Instituto Ecuatoriano de Enfermedades Digestivas (other) |
| Locations | 1 site (Guayaquil) |
| Trial ID | NCT06298604 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a newly developed motorized fine needle biopsy (mFNB) compared to standard fine needle biopsy (FNB) in acquiring tissue samples from the liver and pancreas using endoscopic ultrasound (EUS). The study will involve two groups of patients, one receiving the mFNB and the other the standard FNB, with a focus on assessing sample quality and diagnostic accuracy. The mFNB utilizes advanced technology for controlled tissue cutting and optimized specimen acquisition, potentially improving the quality of biopsies. The trial is conducted at a single center, the Instituto Ecuatoriano de Enfermedades Digestivas in Guayaquil.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 99 who require EUS-guided biopsies of the liver or pancreas and are able to provide consent.
Not a fit: Patients who are pregnant, nursing, have coagulation disorders, or other medical conditions that contraindicate EUS-guided biopsies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved biopsy techniques that provide higher quality tissue samples for better diagnosis of liver and pancreas diseases.
How similar studies have performed: While the approach of using motorized fine needle biopsies is relatively novel, advancements in EUS-guided tissue acquisition have shown promising results in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients between 18 and 99 years * Patients referred to our center who require EUS-guided liver or pancreas biopsy. * Male or female patients. * Patients able to give consent Exclusion Criteria: * Pregnancy or nursing * Patients with coagulation disorders (platelets \<50.000/mm3, international normalised ratio (INR) \>2) * Any underlying medical condition that contraindicates EUS-guided fine needle biopsy such as anatomical alterations, significant gastric outlet obstruction, collateral intervening vessels.
Where this trial is running
Guayaquil
- Instituto Ecuatoriano de Enfermedades Digestivas (IECED) — Guayaquil, Ecuador (RECRUITING)
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: Pancreas Disease, Liver Diseases, Fine-needle biopsy, Endosonography, liver, pancreas, pathology