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

May 18, 2018 updated by: Yang Liu, Chinese PLA General Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1862

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
    • Beijing
      • Beijing, Beijing, China, 100029
        • China-Japan Friendship Hospital
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan cancer hospital
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital Affiliated to Huazhong Technology Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Cancer Hospital
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Xi'an Tangdu Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Shanghai Chest Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Huaxi Hospital Affiliated to Sichuan University
    • Tianjin
      • Tianjin, Tianjin, China, 300051
        • Tianjin Chest Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • First Hospital Affiliated to Medical College, Zhejiang University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pathogically diagnosed IA-IIIB patients with esophageal cancer who received the surgeries of Ivor-Lewis and Mckeown

Description

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)

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
Patients with the surgery of Ivor-Lewis
Pathologically diagnosed IA-IIIB patients with esophageal cancer who received minimally invasive surgery of Ivor-Lewis
Procedure: Surgeries
Minimally invasive surgeries of Ivor-Lewis and Mckeown
Patients with the surgery of Mckeown
Pathologically diagnosed IA-IIIB patients with esophageal cancer who received minimally invasive surgery of Mckeown
Procedure: Surgeries
Minimally invasive surgeries of Ivor-Lewis and Mckeown

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2010 - 2017

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death rates within 30 days after surgeries
Time Frame: 2010 - 2017
Death rates within 30 days after surgeries categorised by tumor biological characteristics
2010 - 2017

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of complications after surgeries
Time Frame: 2010 - 2017
Incidence of complications after surgeries categorised by tumor biological characteristics
2010 - 2017
Incision R0 rates
Time Frame: 2010 - 2017
Incision R0 rates categorised by tumor biological characteristics
2010 - 2017
Percentages of patients who received lymphadenectomy
Time Frame: 2010 - 2017
Percentages of patients who received lymphadenectomy categorised by tumor biological characteristics
2010 - 2017
Extents of lymph metastases
Time Frame: 2010 - 2017
Extents of lymph metastases categorised by tumor biological characteristics
2010 - 2017

Collaborators and Investigators

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

Sponsor

Chinese PLA General Hospital

Collaborators

LinkDoc Technology (Beijing) Co. Ltd.

Investigators

  • Principal Investigator: Yang Liu, PhD, Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 1, 2017

Primary Completion (Actual)

March 30, 2018

Study Completion (Actual)

March 30, 2018

Study Registration Dates

First Submitted

February 5, 2018

First Submitted That Met QC Criteria

February 5, 2018

First Posted (Actual)

February 9, 2018

Study Record Updates

Last Update Posted (Actual)

May 21, 2018

Last Update Submitted That Met QC Criteria

May 18, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 301-EC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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