Feasibility, Safety, and Efficacy of EUS-guided Thermal Radiofrequency Ablation in the Treatment of Gastrointestinal Stromal Tumors

Status: Unknown
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Nowadays, for the selection of the treatment for gastrointestinal stromal tumors (GISTs), tumor size, prognosis, resectability and stage should be considered. Due to mutations in KIT and platelet-derived growth factor alpha (PDGFRA) in 90% of patients with this mesenchymal tumor, many tyrosine kinase inhibitors are used. On the other hand, a resectable tumor is approached by surgery, endoscopic and ablation therapy. Radiofrequency ablation (RFA) approach has been studied in hepatic GISTs, and hepatic metastases, but its evaluation in esophageal, gastric, and intestinal GISTs is scarce. This study aims to determine the feasibility, safety and efficacy of endoscopic ultrasound (EUS) guided RFA using the 19 G RFA probe developed by Taewong Medical for the treatment of GISTs.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Ecuador
Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
RECRUITING
Guayaquil
Contact Information
Primary
Carlos Robles-Medranda, MD FASGE
carlosoakm@yahoo.es
+59342109180
Time Frame
Start Date: 2024-01-15
Completion Date: 2024-09-15
Participants
Target number of participants: 30
Treatments
Experimental: EUS guided RFA
This group is comprised by patients with diagnosis of resectable GISTs with/without liver metastasis. The patients included are naïve (without previous treatment) or patients with stable/progressive disease following systemic therapy with tyrosine kinase inhibitors.
Related Therapeutic Areas
Sponsors
Leads: Instituto Ecuatoriano de Enfermedades Digestivas

This content was sourced from clinicaltrials.gov

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