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| Name | Class |
|---|---|
| Chinese PLA General Hospital | OTHER |
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
| The First Affiliated Hospital of Nanchang University | OTHER |
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To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of robotic radical total gastrectomy and laparoscopic radical total gastrectomy in patients with locally advanced middle and upper gastric adenocarcinoma (CT2-4A, N-/+, M0) .
In the field of gastrectomy, Hashizume et al. first reported robotic gastrectomy in 2002. Since then, reports on the safety and feasibility of the application of robotic surgical system in the treatment of gastric cancer (GC) have gradually increased. Reports of robotic surgery for GC are increasing, especially in Asia. Several studies confirmed the advantages of robotic gastrectomy when compared with laparoscopic gastrectomy. However, whether robotic radical total gastrectomy is noninferior to laparoscopic radical total gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of robotic radical total gastrectomy versus laparoscopic radical total gastrectomy for GC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic radical total gastrectomy with D2 lymphadenectomy | Experimental | After exploration and randomization, patients received robotic radical total gastrectomy with D2 lymphadenectomy |
|
| Laparoscopic radical total gastrectomy with D2 lymphadenectomy | Active Comparator | After exploration and randomization, patients received laparoscopic radical total gastrectomy with D2 lymphadenectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic radical total gastrectomy with D2 lymphadenectomy | Procedure | Most surgical procedures are performed using the robot system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease free survival rate | 3-year disease free survival rate | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity rates | This is for the early postoperative complication, which defined as the event observed within 30 days after surgery. | 30 days |
| 3-year overall survival rate | 3-year overall survival rate |
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Inclusion Criteria:
1.Age between 18 and 75 years 2.The primary gastric lesion was histopathologically diagnosed as middle and upper gastric adenocarcinoma (papillary adenocarcinoma PAP, tubular adenocarcinoma TUB, mucinous adenocarcinoma MUC, signed-ring cell carcinoma SIG, poorly differentiated adenocarcinoma POR) by endoscopic biopsy.
3.Preoperative clinical stages were CT2-4A、 N-/+、and M0 (according to AJCC-8th TNM tumor staging) 4.Excepting to perform radical total gastrectomy and D2 lymph node dissection can achieve R0 resection.
5.American Society of Anesthesiology (ASA) score class I, II, or III 6.Written informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang-ming Huang, MD | Contact | +86-13805069676 | hcmlr2002@163.com | |
| Hua-long Zheng, MD | Contact | +86-18359190587 | 291167038@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Chang-ming Huang, MD | Fujian Medical University Union Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | China |
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| Lanzhou Military Region General Hospital |
| UNKNOWN |
| Gansu Provincial Hospital | OTHER |
| Southwest Hospital, China | OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| Second Xiangya Hospital of Central South University | OTHER |
| Hebei Medical University Fourth Hospital | OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
| The Second Affiliated Hospital of Dalian Medical University | OTHER |
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| Laparoscopic radical total gastrectomy with D2 lymphadenectomy | Procedure | Without the robot system, Most surgical procedures are performed using laparoscopic equipment. |
|
| 36 months |
| 3-year recurrence pattern | Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type. | 36 months |
| intraoperative morbidity rates | The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation. | 1 day |
| overall postoperative serious morbidity rates | Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher | 30 days |
| Total Number of Retrieved Lymph Nodes | Total Number of Retrieved Lymph Nodes | 1 day |
| postoperative recovery course | Duration of postoperative hospital stay in days is used to assess the postoperative recovery course. | 30 days |
| postoperative nutritional status | The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status. | 3, 6, 9 and 12 months |
| inflammatory immune response | The variation of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response | Preoperative 3 days and postoperative 1, 3, and 5 days |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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