Clinical Trial

Feasibility and Safety of Laparoscopic Purse-string Suture Clamp and Multi-functional Seal Cap for Totally Laparoscopic Radical Total Gastrectomy

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Summary
Currently, there are three main methods for endoscopic esophagojejunostomy: circular, linear, and hand-sewn anastomosis, but no universally accepted optimal approach has been established. Hand-sewn anastomosis relies on advanced endoscopic suturing skills, making it technically demanding and only performed in a limited number of hospitals. Linear anastomosis is simple to perform and the most widely used in clinical practice. However, it requires resection of a longer segment of the distal esophagus and may struggle to ensure adequate margins for high-positioned tumors or unclear resection boundaries. Circular anastomosis is a classic method. Its end-to-side approach preserves more esophageal length, making it suitable for high-positioned tumors without the need to close a common opening. Various techniques (e.g., the reverse-puncture method and the Orvil™ transoral anvil technique) have been reported. However, due to challenges such as purse-string suturing, complex anvil placement, and restricted stapler maneuverability, widespread adoption remains difficult. Prof. Du Jianjun's team innovatively employed endoscopic purse-string forceps and a multifunctional sealing ring to achieve circular anastomosis, demonstrating preliminary technical advantages. This study further explores its feasibility and short-term outcomes in totally endoscopic total gastrectomy.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-05.
Trial Details
NCT Number NCT07117812
Lead Sponsor The First Affiliated Hospital with Nanjing Medical University
Conditions Gastric Cancer (GC), Gastrectomy, Anastomosis, Roux-en-Y, Laparoscopic
Enrollment 50 participants
Start Date 2025-09-01
Primary Completion 2027-09-01 (estimated)
Study Completion 2027-09-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-15