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Completed

NCT Number: NCT03428074

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

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

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Observational

Primary location

China-Japan Friendship Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Surgeries

Procedure

Minimally invasive surgeries of Ivor-Lewis and Mckeown

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • LinkDoc Technology (Beijing) Co. Ltd.

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 9, 2018
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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