Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperati… (NCT06348381) | Clinical Trial Compass
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Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation
China250 participantsStarted 2024-04-01
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. History of other malignant tumors;
✕. Incomplete or missing clinical materials;
✕. Received combined surgery (total laryngectomy + esophagectomy, esophagectomy + lung resection, esophagectomy + aorta, etc.);
What they're measuring
1
anastomotic leak
Timeframe: One week to six months after esophagectomy
2
anastomotic stenosis
Timeframe: One week to six months after esophagectomy
3
laryngeal nerve injury
Timeframe: One week to six months after esophagectomy
✕. 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);