NCT06970327

Totally Laparoscopic Distal Gastrectomy VS Pylorus-Preserving Gastrectomy for Early Gastric Cancer in the Middle Stomach

Comparative Study on the Efficacy of Totally Laparoscopic Distal Gastrectomy and Pylorus-Preserving Gastrectomy for Early Gastric Cancer in the Middle Stomach

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 95 (actual)
• Sponsor: Changzhi Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

With the development of laparoscopic technology, the surgical treatment of early gastric cancer (EGC) has shifted towards minimally invasive, precise, and function-preserving strategies. Totally laparoscopic distal gastrectomy (TLDG) and totally laparoscopic pylorus-preserving gastrectomy (TLPPG) are minimally invasive procedures. However, there is a lack of systematic evidence to directly compare their efficacies. This study focuses on two fully laparoscopic techniques, TLDG and TLPPG, to address two key objectives: (1) whether TLPPG can avoid the long-term functional sequelae of TLDG while ensuring oncological safety, including complications (delayed gastric emptying, reflux, and dumping syndrome), postoperative quality of life (assessed via the PGSAS-37 scale), and survival outcomes; and (2) the balance between complications and survival in function-preserving surgery. The findings aim to provide critical technical parameters for individualized surgical decision-making in EGC.

Detailed description

With the continuous advancement and innovation of laparoscopic technology, the surgical treatment paradigm for early gastric cancer (EGC) is undergoing a profound transformation, gradually evolving towards a more minimally invasive, precise, and function-preserving approach. In this context, Totally Laparoscopic Distal Gastrectomy (TLDG) and Totally Laparoscopic Pylorus-Preserving Gastrectomy (TLPPG) have emerged as two highly representative minimally invasive surgical procedures. Characterized by smaller incisions, reduced trauma, and relatively faster postoperative recovery, they have garnered extensive attention in the field of EGC treatment. However, despite their application in clinical practice, there is currently a lack of comprehensive and systematic evidence-based medical data that can directly and thoroughly compare their therapeutic effects. This study will focus on these two advanced laparoscopic surgical techniques, TLDG and TLPPG, and conduct in-depth exploration around two core objectives. Firstly, it will evaluate whether TLPPG can effectively avoid the long-term functional sequelae potentially caused by TLDG while ensuring oncological safety. These sequelae include common complications such as delayed gastric emptying, reflux, and dumping syndrome. Additionally, the study will comprehensively assess patients' postoperative quality of life using the PGSAS-37 scale and further analyze the impact of the two surgical procedures on patients' survival outcomes. Secondly, it will delve into how to achieve the optimal balance between complication control and patients' survival benefits in function-preserving surgeries. Through rigorous data analysis and scientific demonstration, this study aims to provide crucial technical parameters and reliable decision-making bases for the formulation of personalized surgical plans for EGC patients, thereby promoting the development of minimally invasive treatment for early gastric cancer towards a more precise and efficient direction.

Conditions

• Gastrectomy

Timeline

• Start date: 2020-01-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2025-05-14
• Last updated: 2025-05-14

Locations

1 site across 1 country: China