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Search / Trial NCT06348381

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

Launched by SHANGHAI CHEST HOSPITAL · Mar 30, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how certain factors observed during an early endoscopic evaluation (a procedure that allows doctors to look inside the esophagus) can help predict complications after surgery for esophageal cancer. Specifically, it aims to understand the relationship between the anatomy seen during this evaluation and the risk of problems like leaks or narrowing at the surgical site. The trial also looks at how well the recurrent laryngeal nerve, which affects voice and swallowing, recovers after surgery. By tracking changes in vocal cord movement and symptoms like hoarseness, the researchers hope to identify risk factors for delayed recovery.

To be eligible for this trial, participants must be adults aged 18 to 80 who have been diagnosed with esophageal squamous cell carcinoma and are undergoing specific surgical procedures at the hospital from April to July 2024. Participants can expect to undergo endoscopic evaluations to monitor their recovery and provide valuable information to improve future patient care. It's important to note that individuals with certain medical histories or previous surgeries may not qualify for this study.

Gender

ALL

Eligibility 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.

About Shanghai Chest Hospital

Shanghai Chest Hospital is a leading medical institution in China, renowned for its specialized expertise in respiratory and thoracic diseases. As a prominent clinical trial sponsor, the hospital is dedicated to advancing medical research and improving patient outcomes through innovative therapies and treatments. With a strong emphasis on collaboration and scientific rigor, Shanghai Chest Hospital actively engages in a variety of clinical trials aimed at exploring novel interventions and enhancing the understanding of pulmonary health. The hospital's state-of-the-art facilities and commitment to patient-centered care position it as a key player in the global research landscape.

Locations

Shanghai, , China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported