Safety of Robotic Surgery for Gastrointestinal Stromal Tumors at Special Anatomic Sites: A Multicenter, Prospective Clinical Study
This study is a prospective, multicenter, single-arm, phase II clinical trial. It plans to enroll 182 patients with localized gastric gastrointestinal stromal tumors (GISTs) at special anatomic sites. Eligible patients who meet the inclusion/exclusion criteria and provide written informed consent will undergo robotic radical surgery. Postoperative treatment will be determined jointly by the clinicians and patients based on actual clinical practice.
• Aged 18 to 75 years, regardless of sex.
• Diagnosis of GIST located at a special anatomic site confirmed preoperatively by endoscopy/endoscopic ultrasound, CT, or MRI.
• Preoperative imaging suggests a tumor diameter between 2 cm and 5 cm.
• No prior neoadjuvant therapy (e.g., imatinib) administered.
• Expected survival period ≥ 6 months.
• Preoperative assessment indicates feasibility for robotic surgery.
• Preoperative examinations show no evidence of distant metastasis or direct invasion into adjacent organs.
• Preoperative ECOG Performance Status score of 0 or 1.
• Preoperative ASA Physical Status classification of I to III.
• The subject has read and fully understood the patient information sheet and provided written informed consent.