Anastomotic Leaks in Esophageal Squamous Cell Carcinoma Patients After Trimodal Therapy

August 13, 2024 updated by: Qiaoqiao Li

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

218

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Consecutive patients with locally advanced thoracic ESCC who underwent nCRT and surgery at our center between 1 January 2015 and 31 December 2020 were retrospectively identified and analyzed.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

Treatment protocol:

  1. 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.
  2. Concurrent chemotherapy was cisplatin-based.
  3. 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of pathological diagnosis until the date of death from any cause or censoring, assessed up to 36 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qiaoqiao Li

Collaborators

Chinese Institute of Food Science and Technology

Investigators

  • Study Chair: Qiaoqiao Li, Sun Yat-sen University Cancer Center, Guangzhou, China
  • Principal Investigator: Chen Yang, Sun Yat-sen University Cancer Center, Guangzhou, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

September 15, 2023

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Actual)

August 16, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202210172055000282645

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The research data are stored in an institutional repository and will be shared on reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anastomotic Leak Esophagus

Clinical Trials on neoadjuvant chemoradiation and McKeown esophagectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe