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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linear Anastomat Group (L Group) | Experimental | The duodenum and distal stomach were separated by linear anastomat at the planned tangents, and the specimens were taken out to confirm the safe cutting edge.The two arms of the linear anastomat were extended into the posterior wall of the duodenum and small openings at the stump of the greater curvature of the stomach respectively for cutting closure, and then the common openings were closed with the linear anastomat. |
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| Tubular Anastomat Group (C Group) | Active Comparator | The duodenum and distal stomach were separated by tubular anastomat at the planned tangents, and the specimens were taken out to confirm the safe cutting edge.The two arms of the tubular anastomat were extended into the posterior wall of the duodenum and small openings at the stump of the greater curvature of the stomach respectively for cutting closure, and then the common openings were closed with the tubular anastomat. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linear Anastomat | Device | The product registration certificate numbers of linear anastomat is Su Wei registered 20202021581. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Intraoperative Splenic Laceration | The number and percentage of participants experiencing splenic laceration during surgery. | Perioperative period |
| Incidence of Positive Incisal Margin | The number and percentage of participants with a positive incisal margin after tumor resection. | Perioperative period |
| Incidence of Anastomosis Failure | The number and percentage of participants experiencing anastomosis failure during surgery. | Perioperative period |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Procalcitonin Levels | 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). | Perioperative period |
| Change in C-Reactive Protein Levels |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital, Central South University | Changsha | Hunan | 410013 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Tubular Anastomat | Device | The product registration certificate numbers of tubular anastomat is Su Wei registered 20182020305. |
|
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). |
| Perioperative period |
| Change in TNF-α Levels | 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). | Perioperative period |
| Change in Interleukin-6 Levels | 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). | Perioperative period |
| Health-Related Quality of Life assessed by EORTC QLQ-C30 Overall Score | 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. | 3 years |
| Disease-Specific Quality of Life assessed by EORTC QLQ-STO22 Score | 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). | 3 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |