An interventional study of 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 in Early Gastric Cancer, Adenocarcinoma of the Stomach and Proximal Gastric Cancer, sponsored by National Cancer Center, Korea. Recruiting at 1 site in South Korea. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by National Cancer Center, Korea · Not applicable, Interventional, and Treatment
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
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
Background and Rationale: Total gastrectomy has been the standard treatment for proximal gastric cancer, but it often results in a significant decline in quality of life (QoL) due to malnutrition, weight loss, and malabsorption
Study Design and Population: This is a multicenter, prospective, single-arm phase 2 clinical trial
Surgical Procedure (SPADE Operation):
Resection: Surgeons will perform laparoscopic or robotic proximal gastrectomy with D1+ lymph node dissection
Reconstruction: The proximal remnant stomach and the distal esophagus (3 cm above the transected edge) are fixed with interrupted sutures on both sides to create the "spade" shape . Anastomosis: A linear opening is made in the stomach, and the anterior and posterior walls of the esophagus and stomach are sutured using continuous barbed sutures to secure the intra-abdominal positioning of the anastomosis
. Evaluation and Follow-up: Patients will undergo a structured follow-up protocol at 3 weeks, and 3, 6, 12, 18, 24, 30, and 36 months postoperatively
. Primary Endpoint: The incidence of endoscopic reflux esophagitis at 12 months, graded by the Los Angeles (LA) classification
. Secondary Endpoints: Postoperative reflux symptoms (Visick score), changes in nutritional parameters (body weight, hemoglobin, albumin, vitamin B12, etc.), surgical complications (Clavien-Dindo classification), and Quality of Life (using EORTC QLQ-C30 and STO22)
. Survival: 3-year overall survival (OS) and disease-free survival (DFS) will also be monitored
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2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.
This study's planned enrollment of 159 is above the median of 66 across 2,143 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →National Cancer Center, Korea is the lead sponsor of 203 studies on the registry; 36 are open to participants now.
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① Histologically confirmed diagnosis of gastric adenocarcinoma by biopsy.
Adult patients aged 20 years or older.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
④ American Society of Anesthesiologists (ASA) physical status classification of class I to III.
⑤ Patients who have received a full explanation of the study purpose and procedures, and voluntarily signed the informed consent form approved by the Institutional Review Board.
⑥ Patients eligible for proximal gastrectomy satisfying the following oncologic characteristics on preoperative evaluation:
Patients for whom total gastrectomy is the only appropriate treatment (e.g., presence of additional gastric cancer lesions in the distal stomach).
② Patients requiring concomitant resection of other organs due to other diseases.
③ Patients with other malignancies that may affect gastric function preservation indicators:
All participants enrolled in this single-arm study will undergo the SPADE operation (Spade-Shaped Anastomosis). This procedure is performed following a laparoscopic or robotic proximal gastrectomy with D1+ lymph node dissection for patients with early gastric cancer located in the upper third of the stomach . The intervention specifically focuses on a unique reconstruction technique designed to prevent reflux: Anti-reflux Mechanism: The surgeons fix the posterior wall of the distal esophagus (approximately 3 cm above the transected edge) to the proximal part of the residual stomach using single interrupted sutures on both sides * This creates a "spade" shape and reconstructs an artificial angle of His and a pseudo-fornix to maintain the anastomosis in an intra-abdominal position Anastomosis: The opening is created 3 cm inferior to the proximal end of the remnant stomach, and the anterior and posterior walls of the esophagus and stomach are joined using continuous barbed sutures.
Procedure: 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
Incidence of Endoscopic Reflux Esophagitis at 1 Year
The primary goal is to determine the rate of reflux esophagitis exactly 12 months postoperatively * This will be assessed via endoscopy and graded according to the Los Angeles (LA) classification (Grades A, B, C, and D)
Time frame: 1 Year
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Plan to share: No
Started Jun 2025 (actual). Primary completion is estimated for Dec 2028, 42 months after the start.
Of 309 non-industry interventional studies with no phase under Stomach Neoplasms, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 66. This study's planned 42 months is above that.
Counting every sponsor, half of 318 studies reached it within 37 months; a quarter within 19 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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