Robotic removal of stomach GISTs in difficult anatomic locations

Safety of Robotic Surgery for Gastrointestinal Stromal Tumors at Special Anatomic Sites: A Multicenter, Prospective Clinical Study

This study will try robotic radical surgery to remove localized gastric GISTs 2–5 cm located at special anatomic sites in adults who have not received prior neoadjuvant therapy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 182 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (other)
• Drugs / interventions: imatinib, chemotherapy, radiation
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07405125 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm, phase II study planning to enroll 182 adults with localized gastric GISTs at special anatomic sites for robotic radical surgery. Eligible patients (age 18–75, tumor 2–5 cm, ECOG 0–1, no distant metastasis or prior neoadjuvant therapy) will undergo robotic resection and be followed for perioperative and postoperative outcomes. Postoperative treatment decisions will be made jointly by clinicians and patients according to usual clinical practice. The primary emphasis is on surgical safety, feasibility, and oncologic outcomes such as R0 resection rate, intraoperative complications, and functional preservation.

Who should consider this trial

Good fit: Adults 18–75 years with a localized gastric GIST 2–5 cm located at a special anatomic site, ECOG 0–1, no distant metastasis, no prior neoadjuvant therapy, and deemed suitable for robotic surgery are ideal candidates.

Not a fit: Patients with distant metastases, tumors outside the 2–5 cm range, prior gastrectomy or relevant upper-abdominal surgery, prior neoadjuvant therapy, invasion of adjacent organs, or poor performance status are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could allow safer, more precise removal of difficult-to-reach gastric GISTs with better organ and function preservation and fewer complications.

How similar studies have performed: Minimally invasive approaches are well supported for favorable gastric locations, and growing case series suggest robotic surgery is feasible, but high-quality evidence specifically for special anatomic sites remains limited.

Eligibility criteria

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.

Where this trial is running

Nanjing, Jiangsu

• The First Affiliated Hospital with Nanjing Medical University (Jiangsu Province Hospital) — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Qiang Zhang, Ph.D

Conditions: Gastrointenstinal Stromal Tumor