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

NCT ID: NCT06348381

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

No intervention

No intervention

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhigang Li

Deputy director of department of thoracic surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Chest Hospital, Shanghai Jiao Tong University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Zhigang Li, Doctor

Role: primary

zhigang.li@shchest.org

86-18930619260

Other Identifiers

IS24030

Identifier Type: -

Identifier Source: org_study_id