Gastric Cancer
Conditions
Keywords
Linear Anastomat and Tubular Anastomat, Distal radical gastrectomy, Gastroenterostomy
Brief summary
The goal of this clinical trial is to observe and compare the short-term complications, long-term survival and quality of life of linear anastomat and tubular anastomat during digestive tract reconstruction after resection of distal gastric cancer. Participants will receive a linear anastomat or tubular anastomat for digestive tract reconstruction during distal gastrectomy gastroenterostomy.
Interventions
DEVICELinear Anastomat
The product registration certificate numbers of linear anastomat is Su Wei registered 20202021581.
DEVICETubular Anastomat
The product registration certificate numbers of tubular anastomat is Su Wei registered 20182020305.
Sponsors
Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≤ 18 years old ≤75 years old; 2. The primary gastric lesions were diagnosed as gastric adenocarcinoma (papillary adenocarcinoma pap, tubular adenocarcinoma tub, mucinous adenocarcinoma muc, sig-ring cell carcinoma, and poorly differentiated adenocarcinoma por) by gastroscopic biopsy. 3. The patient was clinically diagnosed with gastric cancer (in line with clinical signs of gastrointestinal reconstruction after distal subtotal gastrectomy for gastric cancer); 4. Implantation metastasis without peritoneum (confirmed by laparoscopic exploratory surgery); 5. It is estimated that R0 results can be obtained after D2 radical resection of distal gastric cancer (also applicable for multiple primary lower cancers); 6. Karnofsky score ≥60 points; 7. Preoperative ASA score: I, II, or III; 8。 Routine blood examination (no transfusion within the past 14 days) : HB≥90g/L;ANC ≥1.5×109/L;PLT ≥80×109/L； 9\. Blood biochemical examination: BIL \<1.5 times the upper limit of normal value (ULN);ALT and AST\<2.5× ULN;Crea≤1 x ULN.
Exclusion criteria
1. Previous history of upper abdominal surgery (including gastric ESD/EMR, except laparoscopic cholecystectomy); 2. History of acute pancreatitis; 3. Preoperative imaging examination indicated fusion of enlarged lymph nodes (maximum diameter \>3cm); 4. Gastric cancer patients who have received neoadjuvant therapy; 5. History of other malignant diseases within the past 5 years; 6. History of unstable angina pectoris, myocardial infarction, cerebral infarction, or cerebral hemorrhage within the past 6 months; 7. History of continuous systemic corticosteroid therapy in the past 1 month; 8. Concurrent surgical treatment for other diseases is required; 9. Patients with gastric cancer complications (bleeding, perforation) requiring emergency surgery; 10. Pyloric obstruction; 11. Lung function test FEV1\< 50% of the expected value; 12. Pregnant or lactating women; 13. Suffers from severe mental illness; 14. Participate in other clinical studies at the same time; 15. Refused to sign the first round of study informed consent; 16. Unable or unwilling to comply with research requirements; 17. Patients with PD after neoadjuvant chemotherapy and unable to undergo distal gastrectomy; 18. Patients undergoing emergency surgery due to tumor bleeding, perforation and obstruction during chemotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Intraoperative Splenic Laceration | Perioperative period | The number and percentage of participants experiencing splenic laceration during surgery. |
| Incidence of Positive Incisal Margin | Perioperative period | The number and percentage of participants with a positive incisal margin after tumor resection. |
| Incidence of Anastomosis Failure | Perioperative period | The number and percentage of participants experiencing anastomosis failure during surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Interleukin-6 Levels | Perioperative period | The mean and standard deviation of the percentage of CD3+, CD4+, CD8+, and NK cells among total lymphocytes, measured at designated time points (e.g., pre-operation, 1st post-operative day, 3rd post-operative day). |
| Change in Procalcitonin Levels | Perioperative period | The mean and standard deviation of procalcitonin (pg/mL or ng/mL) measured at designated time points (e.g., pre-operation, 1st post-operative day, 3rd post-operative day). |
| Disease-Specific Quality of Life assessed by EORTC QLQ-STO22 Score | 3 years | The mean and standard deviation of relevant symptom scales and functional scales from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Stomach Module (EORTC QLQ-STO22). |
| Health-Related Quality of Life assessed by EORTC QLQ-C30 Overall Score | 3 years | The mean and standard deviation of the overall global health status/quality of life score from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), ranging from 0 to 100, with higher scores indicating better quality of life. |
| Change in C-Reactive Protein Levels | Perioperative period | The mean and standard deviation of C-reactive protein (mg/L) measured at designated time points (e.g., pre-operation, 1st post-operative day, 3rd post-operative day). |
| Change in TNF-α Levels | Perioperative period | The mean and standard deviation of TNF-α (pg/mL) measured at designated time points (e.g., pre-operation, 1st post-operative day, 3rd post-operative day). |
Countries
China
Outcome results
None listed