NCT07405125

Safety of Robotic Surgery for GISTs at Special Anatomic Sites

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Gastrointestinal stromal tumor (GIST) is the most common mesenchymal tumor of the digestive tract. For localized gastric GISTs, surgical resection remains the cornerstone of curative treatment, adhering to the fundamental principles of complete tumor excision (R0 resection), avoidance of rupture, and negative surgical margins. Since GIST rarely metastasizes to lymph nodes, local resection has become the standard procedure. With advancements in minimally invasive techniques, laparoscopic and robotic surgeries are increasingly utilized in GIST management. International guidelines (NCCN, ESMO) and Asian consensus statements recommend laparoscopic surgery for small tumors (\<5 cm) in favorable anatomic locations (e.g., gastric anterior wall, greater curvature), highlighting benefits such as reduced intraoperative bleeding, lower complication rates, and faster postoperative recovery. However, the applicability of minimally invasive techniques for tumors in special anatomic sites (e.g., cardia, pyloric region) remains controversial. For instance, subcardiac GISTs, due to their proximity to the gastroesophageal junction (GEJ) and critical vascular structures, present significant surgical challenges. Traditional laparoscopic techniques may encounter limitations such as restricted operating space and difficulty in tumor exposure, while excessive resection may lead to loss of cardiac function or postoperative stenosis. Robotic surgical systems, leveraging advantages like three-dimensional high-definition visualization, enhanced instrument flexibility, and tremor filtration, show unique potential for operations within confined anatomic spaces. Compared to conventional laparoscopy, its wristed instruments allow for more precise tumor dissection, potentially reducing injury to adjacent tissues. Stable visual control facilitates R0 resection in complex areas, making it particularly suitable for anatomically challenging regions (e.g., cardia, gastric posterior wall, duodenum). Some retrospective studies report successful preservation of cardiac and pyloric function with R0 resection using robotic surgery. For example, a single-center study involving 25 patients with gastric GISTs in challenging locations like the GEJ and lesser curvature undergoing robot-assisted partial gastrectomy reported preserved cardiac and pyloric function in all cases without tumor rupture. Small-sample studies also confirm that robotic resection for GISTs in the cardia or duodenum can precisely preserve cardiac and ampullary structures, avoiding the need for cardiectomy or pancreaticoduodenectomy. Nevertheless, existing research primarily focuses on the overall efficacy of laparoscopic or robotic techniques, lacking systematic data on the success rate of robotic surgery specifically for gastric GISTs in special anatomic sites. Although the safety of laparoscopic surgery for GISTs in certain special locations (e.g., gastric anterior wall, greater curvature) is supported by some retrospective studies, the potential advantages of robotic surgery in such cases-such as higher rates of function preservation and lower conversion rates to open surgery-remain unclarified. For instance, a multicenter study comparing open, laparoscopic, and robotic resections for gastric GIST found no significant differences in operative time or blood loss between the robotic and laparoscopic groups but did not specifically analyze cases involving special anatomic sites. Another study suggested that robotic surgery might facilitate more precise resection in difficult locations like the GEJ, but more specific, targeted evaluations are lacking. Therefore, this study aims to prospectively analyze the application of robotic surgery for gastric GISTs in special anatomic sites, focusing on evaluating its safety and success rate, thereby addressing gaps in current guidelines and literature. The findings are expected to provide evidence-based support for the broader adoption of robotic surgery in these complex cases and potentially contribute to expanding the indications for minimally invasive techniques.

Conditions

• Gastrointenstinal Stromal Tumor (GIST)

Interventions

Type	Name	Description
PROCEDURE	Robotic Surgery	To perform robotic radical surgery with the aim of achieving R0 resection.

Timeline

• Start date: 2026-02-01
• Primary completion: 2029-01-01
• Completion: 2029-06-01
• First posted: 2026-02-12
• Last updated: 2026-02-12

Locations

1 site across 1 country: China