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

Anastomotic Leak Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06348381
• Other study ID #: IS24030
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2025
• Est. primary completion date: April 1, 2025
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anastomotic Leak
• Anastomotic Stenosis
• Esophageal Neoplasm
• Esophageal Neoplasms
• Recurrence
• Recurrent Laryngeal Nerve Injuries
• Wounds and Injuries

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Shanghai Chest Hospital, Shanghai Jiao Tong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anastomotic leak	leak of the anastomosis	One week to six months after esophagectomy
Primary	anastomotic stenosis	stenosis of anastomosis	One week to six months after esophagectomy
Primary	laryngeal nerve injury	hoarseness symptoms, recovery progression of recurrent laryngeal nerve injury	One week to six months after esophagectomy