Gastric Cancer
Conditions
Keywords
gastric cancer, D2, laparoscopic, open, surgery
Brief summary
The purpose of this study is to evaluate the effect and safety of laparoscopy-assisted D2 radical surgery for distal advanced gastric cancer.
Detailed description
In both arms,subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery (4d, 4sb), hepatoduodenal ligament, superior mesenteric vein) wiil be performed basically. As a general rule, Billroth I or BillrothII methods will be used for gastric reconstruction for all cases. For anastomosis, absorbable suture is used. Anastomotic diameter is 5\ 6 cm length. Drainage tube is inserted through the right flank area and additional drainage tubes can be inserted as needed.
Interventions
PROCEDUREopen surgery
Subtotal gastectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dessection(around common hepatic artery, celiac artery, proximal part of splenic artery, hepatoduodenal ligament, superior mesenteric vein) will be performed basically.
PROCEDURElaparoscopic surgery
Patients in this arm undergo radical resection of gastric cancer in laparoscopic surgery.10 mm trocar under umbilicus, 12 mm and 5 mm trocar at the right flank area are inserted into abdominal wall. Another two 5 mm trocar are inserted into the both midline of subcostal line. The devices for operation are inserted through the trocars. Subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, hepatoduodenal ligament, superior mesenteric vein) will be performed basically. Dissected stomach and lymph node are collected through additional 5-10 cm incision at the preexisting epigastric incision.
Sponsors
Beijing Friendship Hospital
Beijing Shijitan Hospital, Capital Medical University
Xuanwu Hospital, Beijing
Beijing Tongren Hospital
Peking University Cancer Hospital & Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: older than 18 years old，including 18 years old 2. Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma) 3. Cancer core: located at lower part of stomach 4. Preoperative cancer stage : cT2-4a,N0-3,M0 (according to AJCC-7th TNM staging) 5. surgery：subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection 6. ASA score: ≤ 3;ECOG performance status 0/1 7. Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)
Exclusion criteria
1. Concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient 2. Patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy 3. Patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy) 4. Patient who was treated because of systemic inflammatory disease 5. Pregnant patient or lactating women 6. Patient who suffer from bleeding tendency disease, such as hemophilia or patient taking anti-coagulant medication due to deep vein thrombosis 7. serious mental illness 8. gastric surgery (including for gastric ESD / EMR) 9. imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm) 10. other malignant diseases in 5 years 11. have unstable angina or myocardial infarction within six months 12. have cerebral infarction or cerebral hemorrhage within 6 months 13. sustained systemic glucocorticoid treatment history within 1 month 14. have other diseases needed operative treatment at the same time 15. complications (bleeding, perforation, obstruction) required emergency surgery 16. Pulmonary function tests FEV1 \<50% of predicted value.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complication rate | 30 days | Surgical complications within 30 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease free survival rate | 3 years | 3-year disease free survival rate |
Countries
China
Outcome results
None listed