Comparing laparoscopic and open surgery for advanced gastric cancer
Comparison of Laparoscopic Versus Open Total Gastrectomy for Locally Advanced Gastric Cancer: a Prospective Randomized Control Trial
This study is testing whether laparoscopic surgery is safer and more effective than traditional open surgery for patients with advanced gastric cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Medical Center Ho Chi Minh City (UMC) Academic / other |
| Locations | 3 sites (Bien Hoa, Dong Nai and 2 other locations) |
| Trial ID | NCT06202105 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the short- and mid-term outcomes of laparoscopic total gastrectomy (LTG) versus open total gastrectomy (OTG) in patients with locally advanced gastric cancer (GC). Gastric cancer is a major health concern, and while OTG has been the standard surgical approach, advancements in laparoscopic techniques have prompted a need for this comparison. The study will include patients with confirmed gastric adenocarcinoma who require total gastrectomy, assessing the safety and efficacy of LTG in this context. The research is particularly relevant as there is limited data on the long-term outcomes of LTG for advanced cases of gastric cancer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with confirmed gastric adenocarcinoma requiring total gastrectomy and classified as cT2-4aNanyM0.
Not a fit: Patients with concurrent cancers, bulky lymph node metastasis, or those requiring combined esophagectomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence supporting the use of laparoscopic techniques for improved surgical outcomes in patients with advanced gastric cancer.
How similar studies have performed: Previous studies have shown the advantages of laparoscopic techniques for early gastric cancer, but this approach for advanced cases is still being evaluated and lacks extensive prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma * Age: 18 - 80 year old * Tumor required total gastrectomy for radical treatment * Preoperative cancer stage (CT scan stage): cT2-4aNanyM0 * ASA score: ≤ 3 * Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available) Exclusion Criteria: * Concurrent cancer or patient who was treated due to other cancer before the patient was diagnosed gastric cancer * Bulky lymph node andd/or Para-aortic lymph node metastasis * Combined esophagectomy due to invading to the esophagus * Pregnant patient
Where this trial is running
Bien Hoa, Dong Nai and 2 other locations
- Dong Nai General Hospital — Bien Hoa, Dong Nai, Vietnam (Recruiting)
- 108 Military Central Hospital — Hà Nội, Vietnam (Not_yet_recruiting)
- University Medical Center Ho Chi Minh City — Ho Chi Minh City, Vietnam (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.