Endoscopic ultrasound radiofrequency ablation for gastrointestinal stromal tumors
Feasibility, Safety, and Efficacy of EUS-guided Thermal Radiofrequency Ablation in the Treatment of Gastrointestinal Stromal Tumors
This study is testing a new way to treat certain gastrointestinal stromal tumors using a special tool that heats and destroys the tumors without surgery, aimed at helping patients who can't have traditional surgery.
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 |
| Drugs / interventions | imatinib, sunitinib |
| Locations | 1 site (Guayaquil, Guayas) |
| Trial ID | NCT05453292 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility, safety, and efficacy of endoscopic ultrasound (EUS) guided radiofrequency ablation (RFA) for treating gastrointestinal stromal tumors (GISTs) located in the esophagus, stomach, and intestine. It focuses on patients with resectable GISTs that are non-amenable to surgery, specifically those between 2-10 cm in size with low mitotic activity. The approach aims to provide a minimally invasive treatment option for patients who cannot undergo traditional surgical resection. The study will utilize a specialized RFA probe developed by Taewong Medical to assess its effectiveness in this context.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with confirmed resectable GISTs in the esophagus, stomach, or intestine that are between 2-10 cm and have low mitotic activity.
Not a fit: Patients with rectal GISTs, those with significant comorbidities, or who are unable to tolerate general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new minimally invasive option for patients with GISTs who are not candidates for surgery.
How similar studies have performed: While thermal ablation has shown success in treating hepatic metastases from GISTs, the application of this technique for esophageal, gastric, or intestinal GISTs is less established and represents a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (\> 18 years of age) * Confirmed resectable GISTs lesions in esophagus, stomach, and intestine (between 2\<5 cm or 5-10cm and \<5mitotes/HPF) * Non-amenable to surgery * written informed consent * No evidence of metastatic disease on imaging of the chest abdomen and pelvis contrast enhanced computed tomography (CE-CT) or limited liver metastatic disease (maximum 5 lesions \<= 3 cm) * Adequate renal, hepatic, and hematological function Exclusion Criteria: * Pregnancy * Rectal GISTs * Altered renal, hepatic, or hematological function * Inability to provide informed consent * Patients with cardiac pacemakers or other implanted electronic devices and/or electrodes * Patients that have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg), uncontrolled systemic hypertension, and in patients with adult respiratory distress syndrome or any condition that contraindicates the procedure * Inability to tolerate general anesthesia.
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.