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Clinical Trials/NCT03428074
NCT03428074
Completed
Not Applicable

A Multi-centre Real-world Non-interventional Observational Study to Compare Effectiveness and Safety of the Minimally Invasive Surgeries of Ivor-Lewis and Mckeown in Chinese Patients With IA-IIIB Esophageal Cancer

Chinese PLA General Hospital9 sites in 1 country1,862 target enrollmentDecember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophageal Cancer
Sponsor
Chinese PLA General Hospital
Enrollment
1862
Locations
9
Primary Endpoint
Overall survivals in patients with esophageal cancer who received surgeries
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The study was designed to compare effectiveness and safety of the surgeries of Ivor-Lewis and Mckeown in patients with esophageal cancer

Detailed Description

The trial is a multi-centre real-world non-interventional observational study. The study was designed to compare effectiveness and safety of the minimally invasive surgeries of Ivor-Lewis and Mckeown in the Chinese patients with IA-IIIB esophageal cancer via a retrospectively review method based on the study data on patient demographic/tumor biological characteristics and clinical treatments.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
March 30, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chinese PLA General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yang Liu

Professor

Chinese PLA General Hospital

Eligibility Criteria

Inclusion Criteria

  • Pathologically diagnosed middle and lower thoracic IA-IIIB esophageal cancer after surgeries;
  • Patients who received minimally invasive radical dissections of Ivor-Lewis and Mckeown;
  • Patients who received tubular gastroesophageal reconstruction;

Exclusion Criteria

  • Patients complicated with arrhythmia, or serious disfunctions of heart, lung, liver, and kidney before surgeries;
  • Patients with second primary tumors;
  • Patients who received abdominal or thoracic surgeries;
  • Patients who received gastrostomy or nesteostomy before surgeries;
  • Patients with suspected cervical lymph metastases (in the subgroup of the patients who received the surgery of Mckeown)

Outcomes

Primary Outcomes

Overall survivals in patients with esophageal cancer who received surgeries

Time Frame: 2010 - 2017

Overall survivals in patients with esophageal cancer who received surgeries categorised by tumor biological characteristics

Secondary Outcomes

  • Death rates within 30 days after surgeries(2010 - 2017)

Study Sites (9)

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