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Spade-Shaped Anastomosis after Laparoscopic 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 single arm clinical trial.

Spade-Shaped Anastomosis after Laparoscopic 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 single arm clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010229
Enrollment
159
Registered
2025-02-21
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : (1) a specific method of research ? Standardization and quality control of surgery - The conditions of surgeons participating in this clinical trial are that each institution has m

Sponsors

National Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Histologic biopsy diagnosed as gastric cancer ? adult patients over the age of 20 ? ECOG performance is 0-2 ? ASA score class I - III ? Prior to participation in the study, the patient signed a written consent form approved by the Institutional Research Ethics Review Committee to participate in the study according to his/her free will after being fully explained about the purpose and content of the test ? A person who can perform proximal gastrectomy on preoperative examination by satisfying the following oncological characteristics - The tumor is located in the upper third of the stomach (High body, cardia, fundus, gastroesophageal motion (Siewert III)) - The size of the tumor is less than 4 cm - Preoperative stage is below cT1 (submucosal invasion) - The preoperative examination shows that all lymph nodes are N0

Exclusion criteria

Exclusion criteria: ? Patients whose gastric antecedent is the only appropriate treatment (such as the presence of other gastric cancer lesions in the lower part of the stomach) ? a patient who has undergone chemotherapy or radiotherapy prior to surgery for gastric cancer ? a patient who needs a concomitant resection of another organ due to another disease ? Patients with other malignancies affecting gastric function conservation indicators - You have a history of cancer in other organs - If cancer of other organs is currently accompanied - a patient with a history of gastrectomy ? Vulnerable persons (those who lack medical capacity, pregnant women, or those who are planning to become pregnant)

Design outcomes

Primary

MeasureTime frame
Incidence of endoscopic reflux esophagitis

Secondary

MeasureTime frame
Postoperative reflux symptoms;Postoperative weight change;Postoperative complications;Postoperative quality of life;3-year overall survival rate, 3-year disease-free survival rate;Changes in hemoglobin levels after surgery;Changes in serum iron levels after surgery;Changes in postoperative vitamin B12 levels;Changes in postoperative albumin levels;Changes in total protein levels after surgery

Countries

Korea, Republic of

Contacts

Public ContactYoungwoo Kim

National Cancer Center

gskim@ncc.re.kr+82-31-920-1635

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026