NCT07892183Recruiting
SPADE Clinical Trial.
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.
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 159 (estimated)
- First submitted
- 7 Oct 2026
- Start date
- 25 Jun 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- National Cancer Center, Korea
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07892183
What you commit to
- Study type: Interventional
- Planned participants: 159
- From 25 Jun 2025 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Inclusion Criteria
- 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:
- Tumor location: Upper third of the stomach (High body, cardia, fundus, gastroesophageal junction \[Siewert III\])
- Tumor size: 4 cm or less
- Preoperative clinical stage: T1N0, T1N1, T2N0, T2N1 (any differentiation)
- Preoperative clinical stage: T3N0, T3N1 (well or moderate differentiation)
- Expected residual stomach: 60% or more after surgery
- Exclusion Criteria
- 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:
- History of cancer in other organs.
- Presence of concurrent cancer in other organs.
- History of previous gastric resection surgery. ④ Vulnerable populations: patients lacking decision-making capacity, pregnant women, or those planning pregnancy.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center Korea Coordinator of this site? Confirm its status | Goyang | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.