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

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.

Study Overview

• Status: Recruiting
• Conditions: Anastomotic Leak; Esophageal Neoplasm; Anastomotic Stenosis; Recurrent Laryngeal Nerve Injuries; Endoscopic Evaluation
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• China
  • Shanghai, China, SH 21
    • Recruiting
    • Shanghai Chest Hospital, Shanghai Jiao Tong University
    • Contact: Zhigang Li, Doctor; Phone Number: 86-18930619260; Email: zhigang.li@shchest.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients who received radical resection of esophageal cancer in our hospital from April 2024 to July 2024.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anastomotic leak	leak of the anastomosis	One week to six months after esophagectomy
anastomotic stenosis	stenosis of anastomosis	One week to six months after esophagectomy
laryngeal nerve injury	hoarseness symptoms, recovery progression of recurrent laryngeal nerve injury	One week to six months after esophagectomy

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 30, 2024
• First Submitted That Met QC Criteria: March 30, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: March 30, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Postoperative Complications; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Otorhinolaryngologic Diseases; Craniocerebral Trauma; Trauma, Nervous System; Esophageal Diseases; Cranial Nerve Diseases; Laryngeal Diseases; Cranial Nerve Injuries; Vagus Nerve Injuries; Wounds and Injuries; Recurrence; Anastomotic Leak; Esophageal Neoplasms; Laryngeal Nerve Injuries; Recurrent Laryngeal Nerve Injuries
• Other Study ID Numbers: IS24030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No