RecruitingNCT06348381

Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation

Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation: a Prospective, Observational, Non-interventional Study

Sponsor

Shanghai Chest Hospital

Enrollment

250 participants

Start Date

Apr 1, 2024

Study Type

OBSERVATIONAL

Conditions

Esophageal Neoplasm Anastomotic Leak Recurrent Laryngeal Nerve Injuries Anastomotic Stenosis Endoscopic Evaluation

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This observational study looks at whether early endoscopic (camera-based) examination of the throat and esophagus after esophageal cancer surgery can predict serious complications — specifically leaks at the surgical connection point or damage to the nerve controlling the vocal cords. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with thoracic esophageal squamous cell carcinoma (a type of esophageal cancer) - You had radical surgery (esophagectomy using the McKeown procedure with gastric reconstruction and cervical anastomosis) at the study hospital between April and July 2024 - Your ECOG performance status is 0 or 1 (you are mostly active and able to care for yourself) **You may NOT be eligible if...** - You have a history of another malignant tumor - You had a combined surgery involving additional organs - Your medical records are incomplete Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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