Safety of Robotic Surgery for GISTs at Special Anatomic Sites

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.

Eligibility

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 diseases.
* Emergency surgery performed due to tumor-related complications (bleeding, obstruction, or perforation).
* Arterial/venous thrombotic events within 6 months prior to screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (excluding thrombosis related to prior chemotherapy venous catheters deemed resolved by the investigator), and pulmonary embolism.
* Myocardial infarction within 6 months prior to surgery, or poorly controlled arrhythmia (including QTc interval ≥450 ms for males or ≥470 ms for females, calculated using Fridericia's formula).
* Cardiac insufficiency classified as NYHA Class III-IV, or left ventricular ejection fraction (LVEF) \<50% on cardiac ultrasound.
* Ventilatory dysfunction: FEV1 \<50% of predicted value.
* Clinically symptomatic pleural or abdominal effusion requiring clinical intervention.
* Human Immunodeficiency Virus (HIV) infection.
* Active pulmonary tuberculosis.
* History or presence of interstitial lung disease, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired pulmonary function that may interfere with the detection or management of suspected drug-related pulmonary toxicity.
* Any active infection requiring systemic anti-infective therapy within 14 days prior to surgery; except for prophylactic antibiotic therapy (e.g., for urinary tract infection or chronic obstructive pulmonary disease).
* Concurrent participation in another clinical trial involving surgical treatment.
* History of alcohol abuse, drug abuse, or substance abuse. (Note: Patients who have ceased alcohol consumption may be enrolled.)
* Patients deemed likely to be non-compliant with medical advice or medication regimens, or with incomplete data that may affect efficacy or safety assessment.
* Pregnant or lactating female patients.
* Any condition that may increase the risk associated with study participation, or other severe, acute, or chronic diseases, or any other situation that, in the investigator's judgment, makes the patient unsuitable for clinical study participation.

Conditions2

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