Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation: a Prospective, Observational, Non-interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- anastomotic leak
研究概览
简要总结
Analyze the correlation between the conformity of the anatomy (based on endoscopic examination) and postoperative anastomotic fistula and anastomotic stenosis; establish an anastomotic classification; and construct a predictive model combined with perioperative-related test indicators to provide more accurate risk assessment for clinical practice. Analyze the natural recovery process of postoperative recurrent laryngeal nerve injury in esophageal cancer by tracking vocal cord movement (based on endoscopic examination) and hoarseness symptoms; combined with perioperative related surgical and laboratory indicators, identify the relevant risk factors associated with delayed recovery of recurrent laryngeal nerve injury.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with esophageal squamous cell carcinoma;
- •18 - 80 years old;
- •ECOG PS 0-1;
- •Thoracic esophageal cancer (20-40cm from the incisors);
- •Received radical resection of esophageal cancer in our hospital from April 2024 to July 2024;
- •Received the McKeown procedure in our hospital's single treatment group;
- •Received gastric reconstruction and cervical anastomosis with a side-to-side anastomotic device;
- •Complete clinical materials.
排除标准
- •History of other malignant tumors;
- •Incomplete or missing clinical materials;
- •Received combined surgery (total laryngectomy + esophagectomy, esophagectomy + lung resection, esophagectomy + aorta, etc.);
- •Gastric reconstruction or cervical anastomosis with a side-to-side anastomotic device was not performed;
- •Patients who underwent 3-field lymph node dissection;
- •Patients with clear intraoperative recurrent laryngeal nerve section;
- •Highly suspected anastomotic fistula before the first endoscopic evaluation (abnormal secretion at the cervical anastomotic site, abnormal drainage fluid in the chest tube, and high fever that other reasons cannot explain);
- •Lost to follow-up.
结局指标
主要结局
anastomotic leak
时间窗: One week to six months after esophagectomy
leak of the anastomosis
laryngeal nerve injury
时间窗: One week to six months after esophagectomy
hoarseness symptoms, recovery progression of recurrent laryngeal nerve injury
anastomotic stenosis
时间窗: One week to six months after esophagectomy
stenosis of anastomosis
次要结局
未报告次要终点
研究者
Zhigang Li
Deputy director of department of thoracic surgery
Shanghai Chest Hospital