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SPADE Clinical Trial.

RecruitingNAAges 20 Years - anyAllNational Cancer Center, Korea
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In plain words

What the trial is, and whether it could suit you

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 โ‰ค 4 cm) located in the upper third of the stomach who are eligible for gastric function-

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
* Inclusion Criteria โ‘  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. โ‘ฃ American Society of Anesthesiologists (ASA) physical status classification of class I to III. โ‘ค 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. โ‘ฅ Patients eligible for proximal gastrectomy satisfying the following oncologic characteristics on preoperative evaluation: โ€ข 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). โ‘ก Patients requiring concomitant resection of other organs due to other diseases. โ‘ข Patients with other malignancies that may affect gastric function preservation indicators: โ€ข History of cancer in other organs. * Presence of concurrent cancer in other organs. * History of previous gastric resection surgery. โ‘ฃ Vulnerable populations: patients lacking decision-making capacity, pregnant women, or those planning pregnancy.
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What it tests

  • 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
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Where

1 site
National Cancer Center, Korea
Goyang, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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