Xiangya Hospital, Central South University
Changsha, Hunan, 410013, China
NCT Number: NCT07080879
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Changsha, Hunan, 410013, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Perioperative period
The number and percentage of participants experiencing splenic laceration during surgery.
Time frame: Perioperative period
The number and percentage of participants with a positive incisal margin after tumor resection.
Time frame: Perioperative period
The number and percentage of participants experiencing anastomosis failure during surgery.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Xiangya Hospital of Central South University
Other
Clinical Study on the Advantages and Disadvantages of Linear Anastomat and Tubular Anastomat in Gastrointestinal Anastomosis During Radical Gastrectomy for Distal Gastric Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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