Endoscopic Ultrasound Radiofrequency Ablation for GISTs

Launched by INSTITUTO ECUATORIANO DE ENFERMEDADES DIGESTIVAS · Jul 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for gastrointestinal stromal tumors (GISTs), which are a type of tumor found in the digestive system. Specifically, the trial is exploring the use of a procedure called endoscopic ultrasound radiofrequency ablation (EUS-RFA) to see if it is safe and effective for treating GISTs located in the esophagus, stomach, and intestines that cannot be surgically removed. The researchers are looking for adult participants who have confirmed GISTs between 2 and 10 cm in size, have not had their tumors spread to other parts of the body, and are unable to undergo surgery.

If you or a loved one are considering joining this trial, you'll need to be over 18 years old and meet certain health criteria, including good kidney and liver function. Participants will receive the EUS-RFA treatment, which involves using sound waves to target and destroy the tumor tissue. The trial is currently recruiting, meaning they are looking for volunteers to help find out more about this approach. It's important to note that there are specific health conditions that might prevent someone from participating, such as pregnancy or having certain heart or lung issues.

Gender

ALL

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.