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

NCT06348381 | Recruiting

• 1 other identifier: IS24030
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Diagnosed with esophageal squamous cell carcinoma;
• years old;
• ECOG PS 0-1;
• Thoracic esophageal cancer (20-40cm from the incisors);
• Received radical resection of esophageal cancer in our hospital from April 2024 to July 2024;
• Received the McKeown procedure in our hospital's single treatment group;
• Received gastric reconstruction and cervical anastomosis with a side-to-side anastomotic device;
• Complete clinical materials.

You may not qualify if:

• History of other malignant tumors;
• Incomplete or missing clinical materials;
• Received combined surgery (total laryngectomy + esophagectomy, esophagectomy + lung resection, esophagectomy + aorta, etc.);
• Gastric reconstruction or cervical anastomosis with a side-to-side anastomotic device was not performed;
• Patients who underwent 3-field lymph node dissection;
• Patients with clear intraoperative recurrent laryngeal nerve section;
• 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);
• Lost to follow-up.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital, Shanghai Jiao Tong University

Shanghai, SH 21, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Anastomotic Leak; Recurrent Laryngeal Nerve Injuries

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Laryngeal Nerve Injuries; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Injuries; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of department of thoracic surgery

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: April 4, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: December 31, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-03

Locations

CN (1)