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

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ClinicalTrials.gov Identifier: NCT03428074
Recruitment Status : Completed
First Posted : February 9, 2018
Last Update Posted : May 21, 2018
Sponsor:
Collaborator:
LinkDoc Technology (Beijing) Co. Ltd.
Information provided by (Responsible Party):
Yang Liu, Chinese PLA General Hospital

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

Condition or disease Intervention/treatment
Esophageal Cancer Procedure: Surgeries

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
Actual Enrollment : 1862 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: 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
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Death rates within 30 days after surgeries [ Time Frame: 2010 - 2017 ]
    Death rates within 30 days after surgeries categorised by tumor biological characteristics


Other Outcome Measures:
  1. Incidence of complications after surgeries [ Time Frame: 2010 - 2017 ]
    Incidence of complications after surgeries categorised by tumor biological characteristics

  2. Incision R0 rates [ Time Frame: 2010 - 2017 ]
    Incision R0 rates categorised by tumor biological characteristics

  3. Percentages of patients who received lymphadenectomy [ Time Frame: 2010 - 2017 ]
    Percentages of patients who received lymphadenectomy categorised by tumor biological characteristics

  4. Extents of lymph metastases [ Time Frame: 2010 - 2017 ]
    Extents of lymph metastases categorised by tumor biological characteristics



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pathogically diagnosed IA-IIIB patients with esophageal cancer who received the surgeries of Ivor-Lewis and Mckeown
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428074


Locations
China, Beijing
China-Japan Friendship Hospital
Beijing, Beijing, China, 100029
China, Henan
Henan cancer hospital
Zhengzhou, Henan, China, 450008
China, Hubei
Tongji Hospital Affiliated to Huazhong Technology Hospital
Wuhan, Hubei, China, 430030
China, Jiangsu
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210009
China, Shaanxi
Xi'an Tangdu Hospital
Xi'an, Shaanxi, China, 710000
China, Shanghai
Shanghai Chest Hospital
Shanghai, Shanghai, China, 200030
China, Sichuan
Huaxi Hospital Affiliated to Sichuan University
Chengdu, Sichuan, China, 610041
China, Tianjin
Tianjin Chest Hospital
Tianjin, Tianjin, China, 300051
China, Zhejiang
First Hospital Affiliated to Medical College, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
Chinese PLA General Hospital
LinkDoc Technology (Beijing) Co. Ltd.
Investigators
Principal Investigator: Yang Liu, PhD Chinese PLA General Hospital

Responsible Party: Yang Liu, Professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03428074     History of Changes
Other Study ID Numbers: 301-EC-01
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yang Liu, Chinese PLA General Hospital:
Chinese, esophageal cancer, surgeries of Ivor-Lewis/Mckeown

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases