Skip to main content
OpenTrials
Completed

NCT Number: NCT06556355

Anastomotic Leaks in Esophageal Squamous Cell Carcinoma Patients After Trimodal Therapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anastomotic Leak Esophagus Anastomotic Leak Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

neoadjuvant chemoradiation and McKeown esophagectomy

Other

Treatment protocol:

  • All patients were irradiated a total prescribed dose of 40-50.4 Gy in 20-28 fractions by a 6-8 MV photons linear accelerator with the intensity-modulated radiotherapy or volumetric modulated arc therapy technique.
  • Concurrent chemotherapy was cisplatin-based.
  • McKeown esophagectomy (three incision) consisted of thoracic esophageal mobilization with lymphadenectomy, abdominal exploration and stomach mobilization with lymphadenectomy, and subsequently left cervical incision for anastomosis. The lymphadenectomy was total two-field (thoracic + abdomen).

Primary outcomes

  1. anastomotic leak rate

    Time frame: 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 outcomes

  1. Overall survival

    Time frame: 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.

Other outcomes

  1. Pathologic complete response

    Time frame: Up to 1 month

    Pathologic complete response (pCR) was defined as no evidence of residual tumor cells in the primary tumors and resected lymph nodes of the operative specimens.

Sponsors and collaborators

Lead sponsor

Qiaoqiao Li

Other

Collaborators

  • Chinese Institute of Food Science and Technology

Registry information

Official study title

Impact of Preoperative Radiation Dose to the Cervical Esophagus on Anastomotic Leak in Esophageal Squamous Cell Carcinoma Patients After Neoadjuvant Chemoradiation and McKeown Esophagectomy: A Retrospective Analysis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 16, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.