NCT07080879进行中（未招募）不适用
Clinical Study on the Advantages and Disadvantages of Linear Anastomat and Tubular Anastomat in Gastrointestinal Anastomosis During Radical Gastrectomy for Distal Gastric Cancer
Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2023年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Incidence of Intraoperative Splenic Laceration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≤ 18 years old ≤75 years old;
- •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.
- •The patient was clinically diagnosed with gastric cancer (in line with clinical signs of gastrointestinal reconstruction after distal subtotal gastrectomy for gastric cancer);
- •Implantation metastasis without peritoneum (confirmed by laparoscopic exploratory surgery);
- •It is estimated that R0 results can be obtained after D2 radical resection of distal gastric cancer (also applicable for multiple primary lower cancers);
- •Karnofsky score ≥60 points;
- •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；
- •Blood biochemical examination: BIL <1.5 times the upper limit of normal value (ULN);ALT and AST<2.5× ULN;Crea≤1 x ULN.
排除标准
- •Previous history of upper abdominal surgery (including gastric ESD/EMR, except laparoscopic cholecystectomy);
- •History of acute pancreatitis;
- •Preoperative imaging examination indicated fusion of enlarged lymph nodes (maximum diameter >3cm);
- •Gastric cancer patients who have received neoadjuvant therapy;
- •History of other malignant diseases within the past 5 years;
- •History of unstable angina pectoris, myocardial infarction, cerebral infarction, or cerebral hemorrhage within the past 6 months;
- •History of continuous systemic corticosteroid therapy in the past 1 month;
- •Concurrent surgical treatment for other diseases is required;
- •Patients with gastric cancer complications (bleeding, perforation) requiring emergency surgery;
- •Pyloric obstruction;
- •Lung function test FEV1< 50% of the expected value;
- •Pregnant or lactating women;
- •Suffers from severe mental illness;
- •Participate in other clinical studies at the same time;
- •Refused to sign the first round of study informed consent;
- •Unable or unwilling to comply with research requirements;
- •Patients with PD after neoadjuvant chemotherapy and unable to undergo distal gastrectomy;
- •Patients undergoing emergency surgery due to tumor bleeding, perforation and obstruction during chemotherapy.
结局指标
主要结局
Incidence of Intraoperative Splenic Laceration
时间窗: Perioperative period
The number and percentage of participants experiencing splenic laceration during surgery.
Incidence of Positive Incisal Margin
时间窗: Perioperative period
The number and percentage of participants with a positive incisal margin after tumor resection.
Incidence of Anastomosis Failure
时间窗: Perioperative period
The number and percentage of participants experiencing anastomosis failure during surgery.
次要结局
- Change in Procalcitonin Levels(Perioperative period)
- Change in C-Reactive Protein Levels(Perioperative period)
- Change in TNF-α Levels(Perioperative period)
- Change in Interleukin-6 Levels(Perioperative period)
- Health-Related Quality of Life assessed by EORTC QLQ-C30 Overall Score(3 years)
- Disease-Specific Quality of Life assessed by EORTC QLQ-STO22 Score(3 years)
研究者
研究点 (1)
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