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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
The product registration certificate numbers of linear anastomat is Su Wei registered 20202021581.
The product registration certificate numbers of tubular anastomat is Su Wei registered 20182020305.
Xiangya Hospital, Central South University
Changsha, Hunan, China
Incidence of Intraoperative Splenic Laceration
The number and percentage of participants experiencing splenic laceration during surgery.
Time frame: Perioperative period
Incidence of Positive Incisal Margin
The number and percentage of participants with a positive incisal margin after tumor resection.
Time frame: Perioperative period
Incidence of Anastomosis Failure
The number and percentage of participants experiencing anastomosis failure during surgery.
Time frame: Perioperative period
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).
Time frame: Perioperative period
Change in C-Reactive Protein Levels
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).
Time frame: 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).
Time frame: 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).
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Time frame: 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.
Time frame: 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).
Time frame: 3 years