Comparing open and laparoscopic surgery for advanced gastric cancer
Comparison of Laparoscopic Versus Open Distal Gastrectomy for T4a Gastric Cancer: a Prospective Randomized Control Trial
This study is testing whether laparoscopic surgery is a safe and effective option compared to open surgery for patients with advanced stomach cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Medical Center Ho Chi Minh City (UMC) Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Ho Chi Minh City, Ho Chi Minh) |
| Trial ID | NCT04384757 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the technical feasibility and outcomes of open versus laparoscopic distal gastrectomy in patients with T4a stage gastric adenocarcinoma. Given that a significant number of gastric cancer patients in Vietnam are diagnosed at an advanced stage, the research focuses on evaluating both early and long-term results of these surgical approaches. The study will include patients aged 18 to 80 with specific tumor characteristics and will assess the safety and effectiveness of laparoscopic techniques in this challenging patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with confirmed gastric adenocarcinoma at the T4a stage.
Not a fit: Patients with concurrent cancers, previous treatments for cancer, or those requiring total gastrectomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into safer and more effective surgical options for patients with advanced gastric cancer.
How similar studies have performed: While some studies have shown short-term benefits of laparoscopic techniques for advanced gastric cancer, the overall evidence remains limited, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma * Age: 18 - 80 year old * Tumor located at the middle or lower third of the stomach * Preoperative cancer stage (CT scan stage): cT4aN0M0, cT4aN1M0, cT4aN2M0, cT4aN3M0 * 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 * Had another treatment methods, such as chemotherapy, immunotherapy, or radiotherapy * Pregnant patient * Combined resection * Total gastrectomy
Where this trial is running
Ho Chi Minh City, Ho Chi Minh
- University Medical Center — Ho Chi Minh City, Ho Chi Minh, Vietnam (Recruiting)
Study contacts
- Principal investigator: Long D. Vo, PhD, MD — University Medical Center, 215 Hong Bang street, Dist. 5, HCM city, VN
- Study coordinator: Long D. Vo, PhD, MD
- Email: long.vd@umc.edu.vn; longvoduy26@yahoo.com
- Phone: +84918133915
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.