Comparing laparoscopic and open total gastrectomy for gastric cancer
A Prospective, Multicentral, Open-label, Randomized, Controlled Clinical Trial to Compare the Survival, Morbidity and Mortality of Laparoscopic and Open Total Gastrectomy for Gastric Cancer
This study is testing whether laparoscopic surgery for stomach cancer is safer and easier than traditional open surgery for patients with gastric cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05537129 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and feasibility of laparoscopic total gastrectomy compared to open total gastrectomy in patients with gastric cancer. Gastric cancer is a leading cause of cancer-related deaths globally, and while laparoscopic techniques have shown promise in other types of gastrectomy, their effectiveness in total gastrectomy remains to be fully established. The study will involve patients with histologically confirmed gastric adenocarcinoma who meet specific eligibility criteria, including age and clinical staging. Participants will undergo total gastrectomy with D2 lymphadenectomy, and the outcomes will be assessed to determine the advantages of the laparoscopic approach.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20 to 80 with histologically confirmed gastric adenocarcinoma in the upper or middle third of the stomach, who are scheduled for total gastrectomy.
Not a fit: Patients with advanced clinical stages of gastric cancer or those who have received prior chemotherapy or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive surgical option for patients with gastric cancer, potentially leading to improved recovery times and outcomes.
How similar studies have performed: Previous studies have shown that laparoscopic techniques can be safe and effective for other types of gastrectomy, but this specific comparison for total gastrectomy is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. histologically proven gastric adenocarcinoma in the upper or middle third of the stomach (by preoperative gastrofiberscopy) 2. age between 20 and 80 years old 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. clinical stage I-III (T1-4aN0-2M0) according to the 8th edition of the Americal Joint Committee on Cancer System (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography) 5. scheduled for total gastrectomy with D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese 6. written informed consent 7. without preoperative chemotherapy and radiotherapy Exclusion Criteria: 1. clinical stage T1-4N3M0 or T4bN0-3M0 according to the 8th edition of the Americal Joint Committee on Cancer System 2. history of chemotherapy, radiotherapy, immunotherapy or target therapy 3. perigastric lymphnode≥3cm 4. received gastric surgery (i.e. gastrectomy or gastrojejunostomy) 5. multiple primary tumors 6. suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases. 7. patients need emergency operation with complication of gastric cancer 8. adhesion due to the previous intraabdominal surgery 9. need for combined organ resection due to aggression of gastric cancer of other disease, 10. vulnerable people who cannot communicate or are pregnant (or planning to be pregnant) 11. currently participating or participated in other clinical trials in the last 6 months
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Dazhi Xu, PHD,MD — Fudan University
- Study coordinator: Dazhi Xu, PHD, MD
- Email: xudzh@shca.org.cn
- Phone: 021-64175590
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.