Endoscopic Ultrasound Radiofrequency Ablation for GISTs

Gastrointestinal Stromal Tumor (GIST) Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Gastrointestinal stromal tumors (GISTs) are the most common malignant mesenchymal tumors of the gastrointestinal tract. GISTs usually appear like subepithelial lesions covered by normal mucosa, arising from the second of fourth layer of the gastrointestinal tract wall. They are variable in size and mostly asymptomatic, but they can present different clinical behavior as bleeding, pain, or obstruction. The tumor size, location and mitotic rate are important prognostic factors. For resectable tumors >2 cm, surgery is the treatment of choice; the management of tumors <2 cm remains debatable because they present unclear clinical significance and low risk of malignancy. Endoscopic treatment, when complete resection it's possible, could be an option to full thickness laparoscopic resection. Moreover, around 90% of GISTs harbour driver mutation in KIT and platelet-derived growth factor alpha (PDGFRA), making the treatment with tyrosine kinase inhibitors (i.e., imatinib, sunitinib and regorafenib) a suitable option for locally advanced and metastatic disease. Nevertheless, the role of local treatment in advanced and metastatic disease is limited, with few retrospective studies suggesting tumor ablation as a therapeutic approach.

According to literature, thermal ablation has been successfully used for local treatment of hepatic metastases from GISTs (as a curative treatment). However, its feasibility and technical success as a local treatment in esophageal, gastric or intestinal GISTs has not been evaluated.

The investigators aimed to determine the feasibility and efficacy of the RFA electrode developed by Taewong Medical for the treatment of resectable GISTs (esophageal, gastric and intestinal lesions) as well as its limited liver metastases in naïve patients or patients with stable disease following systemic therapy with tyrosine kinase inhibitors. The challenge is whether to introduce local ablative therapy as curative or as part of multimodal treatment in patients with GISTs to obtain a curable disease and an increase in overall survival for metastatic patients. ;

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumor (GIST)
• Gastrointestinal Stromal Tumors

• NCT number: NCT05453292
• Study type: Interventional
• Source: Instituto Ecuatoriano de Enfermedades Digestivas
• Contact: Carlos Robles-Medranda, MD FASGE
• Phone: +59342109180
• Email: carlosoakm@yahoo.es
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Completion date: September 15, 2024