A Observational Study to Compare Effectiveness and Safety of the Surgeries in Patients With Esophageal Cancer

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: March 30, 2018

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.

Interventions

  • Procedure: Surgeries
    • Minimally invasive surgeries of Ivor-Lewis and Mckeown

Arms, Groups and Cohorts

  • Patients with the surgery of Ivor-Lewis
    • Pathologically diagnosed IA-IIIB patients with esophageal cancer who received minimally invasive surgery of Ivor-Lewis
  • Patients with the surgery of Mckeown
    • Pathologically diagnosed IA-IIIB patients with esophageal cancer who received minimally invasive surgery of Mckeown

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Death rates within 30 days after surgeries
    • Time Frame: 2010 – 2017
    • Death rates within 30 days after surgeries categorised by tumor biological characteristics

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese PLA General Hospital
  • Collaborator
    • LinkDoc Technology (Beijing) Co. Ltd.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yang Liu, Professor – Chinese PLA General Hospital
  • Overall Official(s)
    • Yang Liu, PhD, Principal Investigator, Chinese PLA General Hospital

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