Clinical trial NCT05453292: Endoscopic Ultrasound Radiofrequency Ablation for GISTs
Official title: Feasibility, Safety, and Efficacy of EUS-guided Thermal Radiofrequency Ablation in the Treatment of Gastrointestinal Stromal Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Stromal Tumor (GIST)
Keywords: Gastrointestinal stromal tumor
Radiofrequency
Endosonography
Lead sponsor: Instituto Ecuatoriano de Enfermedades Digestivas
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A non-blinded, single center, non-randomized prospective feasibility trial.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: up to 6 months
measure: Technical success of RFA of GISTs lesions and metastasis
timeFrame: up to 2 hours
measure: Disease-free survival
timeFrame: up to 6 months
Secondary outcomes:
measure: Re-treatment rate
timeFrame: 1-month
Other outcomes:
Locations:
city: Guayaquil
country: Ecuador
facility: Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
state: Guayas
Study officials:
affiliation: Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
name: Carlos Robles-Medranda, MD FASGE
role: PRINCIPAL_INVESTIGATOR
References:
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