Safety of Robotic Surgery for GISTs at Special Anatomic Sites (NCT07405125) | Clinical Trial Compass
RecruitingNot Applicable
Safety of Robotic Surgery for GISTs at Special Anatomic Sites
China182 participantsStarted 2026-02-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* History of previous upper abdominal surgery (except laparoscopic cholecystectomy).
* History of previous gastrectomy, endoscopic mucosal resection (EMR), or endoscopic submucosal dissection (ESD).
* Previous administration of neoadjuvant therapy (e.g., imatinib).
* Presence of other active malignancies within the past 5 years or concurrently. (Note: Patients with cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervical carcinoma in situ, breast carcinoma in situ, Stage I lung cancer, or Stage I colorectal cancer, may be enrolled.)
* Requirement for concurrent surgery for other d…
What they're measuring
1
3-year disease-free survival rate (3-year DFS)
Timeframe: Patients were followed for 3 years after undergoing robotic surgery.
Trial details
NCT IDNCT07405125
SponsorThe First Affiliated Hospital with Nanjing Medical University