Safety of Robotic Surgery for GISTs at Special Anatomic Sites
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital with Nanjing Medical University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.)
Trial design
Treatments tested in this trial
- Robotic Surgery
Treatment groups
182 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov