NCT05537129 Laparoscopic vs Open Total Gastrectomy for Gastric Cancer
| NCT ID | NCT05537129 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2024-10-01 |
Trial Parameters
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Brief Summary
The aim of the present study is to demonstrated the the safety and feasibility of laparoscopic total gastrectomy comparing with open total gastrectomy.
Eligibility 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 gast
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