SPADE procedure for upper stomach cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective, single-arm phase 2 trial evaluating the SPADE (Spade-Shaped Anastomosis) technique after laparoscopic or robotic proximal gastrectomy for early gastric cancer located in the upper stomach. The goal is to determine safety, feasibility, and clinical outcomes of a built-in anti-reflux mechanism using the angle of His reconstruction. Approximately 159 patients (allowing for 10% dropout) with tumors ≤4 cm will be enrolled and treated with the SPADE reconstruction after D1+ lymph node dissection. Eligibility includes histologically confirmed gastric adenocarcinoma, age 20 or older, ECOG 0-2, ASA I-III, and specific preoperative staging indicating suitability for proximal gastrectomy. The study aims to preserve gastric function while reducing reflux symptoms compared with traditional reconstructions.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Cancer Center, Korea
  Goyang, Gyeonggido, South Korea Recruiting

Study contacts

• Study coordinator: Young-Woo Kim, Ph.D
• Email: youngwookim@ncc.re.kr
• Phone: +82-31-920-1635

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Explainable multimodal AI for diagnosing early gastric cancer from endoscopic images

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.