Laparoscopic total gastrectomy for gastric cancer
Official title: Multicenter Randomized Controlled Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)
Run by Yonsei University · NCT03385018 · Data updated 2026-11-12
This study is testing if a less invasive surgical method for removing the stomach can be safer and more effective for people with advanced gastric cancer compared to traditional open surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 80 Years |
| Sex | All |
| Enrollment | 772 (estimated) |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | April 5, 2018 |
| Main results expected | December 31, 2022 |
| Study ends | December 31, 2027 |
| Registry record updated | March 19, 2019 |
| Trial ID | NCT03385018 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 20 to 80 with resectable gastric adenocarcinoma and a performance status of ECOG 0 or 1.
✕Probably not a fit
Patients with distant metastasis or those whose tumors cannot be curatively resected will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to compare the efficacy and safety of laparoscopic total gastrectomy with D2 lymph node dissection against traditional open surgery for patients with proximal advanced gastric cancer. The study will involve a multicenter randomized approach to assess technical outcomes and oncologic safety. By focusing on patients who can undergo curative resection, the trial seeks to provide robust data on the laparoscopic method's effectiveness in this challenging surgical context.
Why it matters
Potential benefit: If successful, this approach could lead to less invasive surgical options for patients with gastric cancer, potentially improving recovery times and outcomes.
How similar studies have gone: While laparoscopic techniques have shown promise in other studies, this specific comparison with open surgery for proximal gastric cancer is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who are over 20 and below 80 years old * Patients who have performance status of ECOG 0 or 1 * Patients with American Society of Anesthesiology score of class I to III * Patients who are diagnosed with gastric adenocarcinoma not involving Z-line by endoscopy with biopsy * Patients with tumors which can be curatively resected by total gastrectomy with lymph node dissection based on preoperative study * Patients who have primary gastric carcinoma invaded into over muscle propria, and not into adjacent organ in preoperative studies (cT2 \~ cT4a) * Patients who have no metastasis to lymph nodes or limited metastasis to perigastric lymph node metastasis in preoperative studies (cN0 \~ cN2) * Patients who agree with participating in the clinical study with informed consents * Patients who can be followed for at least 3 years after study enrollment Exclusion Criteria: * Patients who have possibility of distant metastasis in preoperative studies * Patients who have history of gastric resection with any cause * Patients who have complications (bleeding or obstruction) of gastric cancer * Patients who are treated by chemo(radio)therapy or endoscopic submucosal dissection for gastric cancer * Patients who are diagnosed and treated with other malignancies within 5 years * Vulnerable patients * Patients who participating or participated in other clinical trial within 6 months
Where it's running
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Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Woo Jin Hyung, MD, PhD
- Email: wjhyung@yuhs.ac
- Phone: +82-2-2228-2100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.