| NCT ID | NCT07892183 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Center, Korea |
| Condition | Early Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 159 participants |
| Start Date | 2025-06-25 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 159 participants in total. It began in 2025-06-25 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
* 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07892183 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Early Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07892183 currently recruiting?
Yes, NCT07892183 is actively recruiting participants. Contact the research team at youngwookim@ncc.re.kr for enrollment information.
Where is the NCT07892183 trial being conducted?
This trial is being conducted at Goyang, South Korea.
Who is sponsoring the NCT07892183 clinical trial?
NCT07892183 is sponsored by National Cancer Center, Korea. The trial plans to enroll 159 participants.
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