Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Peking University Cancer Hospital & Institute | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| Fujian Cancer Hospital | OTHER_GOV |
| Fujian Medical University Union Hospital |
Not provided
Not provided
Not provided
Not provided
This is a phase III, multicenter, prospective, randomized, controlled clinical trial to evaluate the impact of omentectomy for advanced gastric cancer on patient survival.
In order to evaluate the impact of omentectomy for advanced gastric cancer on patient survival, we designed this trial. Patients who received curative gastrectomy were divided into two groups based on whether they underwent omentectomy. The purpose of this study is to prove the non-inferiority of omentum preservation compared with omentectomy in patients with T3-T4a gastric cancer.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group/D2 radical gastrectomy with partial omentectomy | Experimental | Partial omentectomy with preservation of the greater omentum at >3 cm from the gastroepiploic arcade. |
|
| Control group/D2 radical gastrectomy with total omentectom | No Intervention | Control group with total omentectomy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Type of omentectomy | Procedure | Experimental group D2 radical gastrectomy with partial omentectomy. Partial omentectomy with preservation of the greater omentum at >3 cm from the gastroepiploic arcade.Control group with total omentectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival(DFS) | Disease Free Survivalof the Participants | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | Overall Survival of the Participants | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| The volume of intraoperative blood loss | The volume of intraoperative blood loss (IBL) was defined as the total from suction and the weight of gauze sponges at the conclusion of the operation. The Blood loss volume is recorded in milliliters. | 1 week |
| Postoperative morbidity |
Inclusion Criteria:
12. Not greater curvature tumor; with distal or total gastrectomyï¼› 13. No previous surgery for any abdominal disease, except an appendectomy for appendicitis, a laparoscopic cholecystectomy for gallbladder stones; No previous history of peritonitis, pancreatitis; 14. Karnofsky performance status (KPS)>60; Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1.
Exclusion Criteria:
Pregnancy or breast feeding; 2. Patients with Serious liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, hypertension and other chronic systemic diseases, heart disease with Clinical symptoms, such as congestive heart failure, coronary heart disease symptoms, drug is difficult to control arrhythmia, hypertension, or six months had a myocardial infarction attack, or cardiac insufficiency; 3. Organ transplantation patients need immunosuppressive therapy; 4. Severe recurrent infections were not controlled or with other serious concomitant diseases; 5. Patients got other primary malignant tumors (except curable skin basal cell carcinoma and cervical cancer in situ) except gastric cancer within 5 years; 6. Psychiatric disease which require treatment; 7. Have the history of organ transplantation; 8. Within 6 months before study starts and in the process of this study, patients participate in other clinical researches. 9. Advanced gastric cancer with omentum invasion 10. Patients can't treated with XELOX after surgery; 11 . Macroscopic types : Borrmann IV; 12. Tumor invasion of adjacent organ (T4b) or with distant metastasis#M1 #; 13. Tumor invasion the greater curvature invasion.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Han Liang, Master | Contact | +86 022 233401 23 | 1061 | tjlianghan@126.com |
| Bik Ke, Doctor | Contact | +86 022 23340123 | 1061 | binke@tmu.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| Harbin Medical University | OTHER |
| Hebei Medical University Fourth Hospital | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Changzhi People's Hospital | OTHER |
| The First Affiliated Hospital of Air Force Medicial University | OTHER |
| First Affiliated Hospital of Kunming Medical University | OTHER |
| LanZhou University | OTHER |
| Liaoning Cancer Hospital & Institute | OTHER |
| The First Affiliated Hospital of Nanchang University | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| West China Hospital | OTHER |
| Xinjiang Medical University Cancer Hospital | UNKNOWN |
| Zhejiang Cancer Hospital | OTHER |
| Chinese PLA General Hospital | OTHER |
| Sun Yat-Sen University Cancer Center | OTHER |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Postoperative morbidity was defined as the incidence rate of the postoperative complication. The postoperative morbidity were examined within 30 days after surgery. Postoperative morbidity was graded with use of the modified Clavien-Dindo classification of surgical complications. |
| 1 month |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |