Comparing two surgical methods for advanced gastric cancer treatment
Comparison Between Partial Omentectomy and Total Omentectomy During Minimally Invasive Radical Distal Gastrectomy for Clinical T3 and T4a Gastric Cancer; Multicenter Randomized Clinical Trial (KLASS-10)
This study is testing whether removing all or just part of a certain fatty tissue during stomach surgery helps people with advanced gastric cancer do better and stay safe.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 20 Years to 85 Years |
| Sex | All |
| Sponsor | Gangnam Severance Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06608381 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the effectiveness of partial versus total omentectomy during minimally invasive distal gastrectomy for patients with advanced gastric cancer. The study aims to determine whether total omentectomy, which involves complete removal of the greater omentum, provides any significant oncological benefits compared to partial omentectomy, while also assessing the associated risks and complications. By evaluating surgical outcomes, the trial seeks to establish the best approach for ensuring patient safety and effective cancer treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 to 85 with histologically proven adenocarcinoma of the stomach and clinical T3 or T4a tumors.
Not a fit: Patients with confirmed distant metastasis or those who have previously undergone gastrectomy or omentectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing surgery for advanced gastric cancer.
How similar studies have performed: While the approach of comparing omentectomy techniques is not widely tested, similar studies in minimally invasive surgery have shown promising results in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically proven adenocarcinoma of the stomach * Age between 20 to 85 years old * ECOG PS 0-1, ASA class I-III * Endoscopically Borrmann type I, II, III * Clinical T3 and T4a tumors with or without regional lymph node metastases (cT3N0M0\~T4aN3M0) * Capable of minimal invasive radical subtotal gastrectomy with R0 resection in preoperative examinations * Patients who signed an written consent form approved by the Institutional Review Board(IRB) after receiving sufficient explanations of the contents of the clinical trial * Domestic patients who are able to follow up for 3 years after surgery Exclusion Criteria: * Confirmed distant metastasis in preoperative examinations * Confirmed metastasis in abdominal cavity or distant organs during surgery * Confirmed no infiltration of the serosa layer or unable to confirm the tumor location during surgery (sT1-2) * Confirmed invasion of surrounding organs (sT4b) * History of previous gastrectomy or greater omentum related surgery * Patients who underwent preoperative treatment (chemotherapy, radiotherapy, or endoscopic submucosal dissection) for recently diagnosed gastric cancer * Synchronous or metachronous malignancies, which underwent surgery, chemotherapy or radiotherapy within 5 years * Patients judged to be inappropriate for the study by the physician. (ex. Pregnancy) * Patients refused to participate after random assignment * Surgery is not performed until 30 days after consenting to participate * Patients who has participated in another on-going clinical trial, which is related surgical procedures and survival.
Where this trial is running
Seoul
- GangnamSeverance Hospital — Seoul, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.