Predicting complications after esophageal cancer surgery using endoscopic evaluation
Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation: a Prospective, Observational, Non-interventional Study
This study is testing if looking at the esophagus through a camera can help predict complications after surgery for esophageal cancer and track recovery from voice problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai Chest Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06348381 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the relationship between anatomical conformity observed through endoscopic examination and the occurrence of postoperative complications such as anastomotic leaks and stenosis in patients with esophageal cancer. It seeks to establish a classification system for anastomotic complications and develop a predictive model that incorporates perioperative indicators for better risk assessment. Additionally, the study will track the recovery of recurrent laryngeal nerve injury by monitoring vocal cord movement and hoarseness symptoms, identifying risk factors that may delay recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 diagnosed with esophageal squamous cell carcinoma who have undergone radical resection at the participating hospital.
Not a fit: Patients with a history of other malignant tumors or those who have undergone combined surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for patients undergoing esophageal cancer surgery.
How similar studies have performed: While similar studies have explored postoperative complications in esophageal surgery, this specific predictive approach using endoscopic evaluation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosed with esophageal squamous cell carcinoma; 2. 18 - 80 years old; 3. ECOG PS 0-1; 4. Thoracic esophageal cancer (20-40cm from the incisors); 5. Received radical resection of esophageal cancer in our hospital from April 2024 to July 2024; 6. Received the McKeown procedure in our hospital's single treatment group; 7. Received gastric reconstruction and cervical anastomosis with a side-to-side anastomotic device; 8. Complete clinical materials. Exclusion Criteria: 1. History of other malignant tumors; 2. Incomplete or missing clinical materials; 3. Received combined surgery (total laryngectomy + esophagectomy, esophagectomy + lung resection, esophagectomy + aorta, etc.); 4. Gastric reconstruction or cervical anastomosis with a side-to-side anastomotic device was not performed; 5. Patients who underwent 3-field lymph node dissection; 6. Patients with clear intraoperative recurrent laryngeal nerve section; 7. 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); 8. Lost to follow-up.
Where this trial is running
Shanghai
- Shanghai Chest Hospital, Shanghai Jiao Tong University — Shanghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.