Detective flow imaging endoscopic ultrasonography for diagnosing subepithelial lesions
Diagnosis of Gastrointestinal Subepithelial Lesions Using a Novel Endoscopic Ultrasonography Imaging Technique
This study is testing a new imaging technique to see if it can better identify certain types of growths in the digestive system, helping doctors tell the difference between cancerous and non-cancerous tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Instituto Ecuatoriano de Enfermedades Digestivas Academic / other |
| Locations | 1 site (Guayaquil, Guayas) |
| Trial ID | NCT05474794 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a novel diagnostic method called detective flow imaging endoscopic ultrasonography (DFI-EUS) for the assessment of subepithelial lesions (SELs) in the gastrointestinal tract, particularly focusing on differentiating gastrointestinal stromal tumors (GISTs) from benign leiomyomas. The study aims to improve diagnostic accuracy by utilizing DFI-EUS, which is designed to detect slow and fine blood flow in these lesions without the risks associated with contrast agents. Patients referred for endoscopic ultrasound (EUS) will be included, and the effectiveness of DFI-EUS will be compared to traditional contrast-enhanced EUS (CE-EUS).
Who should consider this trial
Good fit: Ideal candidates for this study are patients referred for endoscopic ultrasound evaluation of subepithelial lesions.
Not a fit: Patients with contraindications for contrast agent administration or those with clinical conditions that make EUS inviable will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses of GISTs, allowing for better treatment decisions and improved patient outcomes.
How similar studies have performed: While traditional EUS techniques have been utilized, the DFI-EUS approach is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients referred to our center with an indication of EUS for the evaluation of SELs * Patients who authorized for DFI or CE-EUS. * Written informed consent Exclusion Criteria: * Patients with contraindication for contrast agent administration. * Any clinical condition which makes EUS-DFI or CE-EUS inviable * Pregnancy
Where this trial is running
Guayaquil, Guayas
- Instituto Ecuatoriano de Enfermedades Digestivas (IECED) — Guayaquil, Guayas, Ecuador (Recruiting)
Study contacts
- Principal investigator: Carlos Robles-Medranda, MD FASGE — Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
- Study coordinator: Carlos Robles-Medranda, MD FASGE
- Email: carlosoakm@yahoo.es
- Phone: +59342109180
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.