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SPADE Clinical Trial.
Sponsor: National Cancer Center, Korea
Summary
Purpose: This multicenter, prospective, single-arm phase 2 clinical trial aims to evaluate the safety, feasibility, and clinical outcomes of the SPADE operation (Spade-Shaped Anastomosis) in patients undergoing laparoscopic or robotic proximal gastrectomy for early gastric cancer located in the upper stomach . Background: While proximal gastrectomy (removing only the upper part of the stomach) offers nutritional advantages over total gastrectomy, it often leads to significant postoperative reflux esophagitis * The SPADE technique was developed to prevent this by creating an artificial anti-reflux mechanism (angle of His and pseudo-fornix) using double suture anchoring between the esophagus and the stomach Study Plan: Participants: The study will enroll approximately 159 patients with tumors (size ≤ 4 cm) located in the upper third of the stomach who are eligible for gastric function-preserving surgery . Intervention: All participants will undergo laparoscopic or robotic proximal gastrectomy followed by the SPADE reconstruction method . Primary Objective: The primary goal is to determine the incidence of endoscopic reflux esophagitis at one year postoperatively . Secondary Objectives: Investigators will also monitor postoperative reflux symptoms, nutritional parameters (such as weight, hemoglobin, and vitamin B12 levels), surgical complications, quality of life, and 3-year survival rates . Hypothesis: The researchers hypothesize that the SPADE operation is a safe and effective surgical approach that can provide equivalent reflux prevention (a target rate of approximately 2.9%) compared to existing complex reconstruction methods, while maintaining the benefits of preserving gastric function
Official title: Spade-Shaped Anastomosis After Laparoscopic or Robotic Proximal Gastrectomy Using Double Suture Anchoring Between the Posterior Wall of the Esophagus and the Anterior Wall of the Stomach (SPADE Operation): a Multicenter Prospective Clinical Trial.
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
159
Start Date
2025-06-25
Completion Date
2030-12-31
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
Spade-Shaped Anastomosis after Laparoscopic or Robotic Proximal Gastrectomy Using Double Suture Anchoring between the Posterior Wall of the Esophagus and the Anterior Wall of the Stomac
The SPADE operation (Spade-Shaped Anastomosis) is a specialized reconstruction technique performed following a laparoscopic or robotic proximal gastrectomy for patients with upper-third early gastric cancer * The intervention involves several key technical steps designed to preserve gastric function and prevent postoperative reflux: Surgical Approach and Resection: The procedure begins with a laparoscopic or robotic proximal gastrectomy accompanied by D1+ lymph node dissection * Surgeons must preserve the hepatic branch of the vagus nerve in all patients * The esophagus is resected just above the esophagogastric junction (EGJ) using a linear stapler Anchoring and Fixation: To create an anti-reflux mechanism, the proximal part of the residual stomach and the distal esophagus (3 cm above the transected edge) are fixed using single interrupted sutures on both sides * This "double suture anchoring" ensures the anastomosis remains in an intra-abdominal position and creates an ar
Locations (1)
National Cancer Center, Korea
Goyang, Gyeonggido, South Korea