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Endoscopic Ultrasound Radiofrequency Ablation for GISTs

Ecuador30 participantsStarted 2024-01-15

Plain-language 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.

Who can participate

Age range18 Years – 89 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Incidence of adverse events

Timeframe: up to 6 months

Technical success of RFA of GISTs lesions and metastasis

Timeframe: up to 2 hours

Disease-free survival

Timeframe: up to 6 months

Trial details

NCT IDNCT05453292

SponsorInstituto Ecuatoriano de Enfermedades Digestivas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-15

Contact for this trial

Carlos Robles-Medranda, MD FASGE

+59342109180 carlosoakm@yahoo.es