Anastomotic Leaks in Esophageal Squamous Cell Carcinoma Patients After Trimodal Therapy

Completed

• Conditions: Anastomotic Leak Esophagus
• Interventions: Other: neoadjuvant chemoradiation and McKeown esophagectomy

• Registration Number: NCT06556355
• Lead Sponsor: Qiaoqiao Li

Brief Summary

To investigate the clinical factors and preoperative treatment to the future anastomotic location of cervical esophagus that were correlated with anastomotic leaks in esophageal squamous cell carcinoma patients undergoing neoadjuvant chemoradiation and McKeown esophagectomy and to explore the prognosis of anastomotic leak.

Detailed Description

The goal of this observational study is to investigate the clinical factors and preoperative treatment to the future anastomotic location of cervical esophagus that were correlated with anastomotic leaks in esophageal squamous cell carcinoma patients undergoing neoadjuvant chemoradiation and McKeown esophagectomy and to explore the postoperative complications, mortality, and long-term survival of different types of anastomotic leak.

Study Timeline

• Study Start: 2022-11-01
• Primary Completion: 2023-09-15
• Study Completion: 2023-09-15
• Status Verified: 2024-08
• Study First Submitted: 2024-08-07
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-16
• Last Update Posted: 2024-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

• histologically confirmed ESCC;
• clinically staged as T3-4aN0M0 or T1-4aN+M0 by the eighth edition of the American Joint Committee on Cancer and treated with nCRT followed by McKeown esophagectomy24;
• aged 18-75 years;
• Eastern Cooperative Oncology Group performance status score ≤ 2.

Exclusion Criteria

• cervical esophageal cancer;
• previously treated with chest radiotherapy, esophageal, or gastric surgery;
• insufficient clinical data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Overall patients	neoadjuvant chemoradiation and McKeown esophagectomy	Consecutive patients with locally advanced thoracic ESCC who underwent nCRT and surgery at our center between 1 January 2015 and 31 December 2020.

Primary Outcome Measures

Name	Time	Method
anastomotic leak rate	Up to 1 month	According to the consensus on standardization of data collection for complications associated with esophagectomy by the Esophagectomy Complications Consensus Group (ECCG), anastomotic leak was defined as a full-thickness gastrointestinal defect involving the esophagus, anastomosis, staple line or conduit, which was diagnosed as extravasation of water-soluble contrast during a swallow study, postoperative esophageal barium X-ray or CT scan, visualization of anastomotic dehiscence or leak during endoscopy, or salivary fluid in the cervical region.

Secondary Outcome Measures

Name	Time	Method
Overall survival	From date of pathological diagnosis until the date of death from any cause or censoring, assessed up to 36 months	Overall survival (OS) was defined as the duration from the date of pathological diagnosis to the date of death or censoring.

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China