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

NCT ID: NCT03428074

Last Updated: 2018-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1862 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-03-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Esophageal Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with the surgery of Ivor-Lewis

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

Surgeries

Intervention Type PROCEDURE

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

Surgeries

Intervention Type PROCEDURE

Minimally invasive surgeries of Ivor-Lewis and Mckeown

Interventions

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Surgeries

Minimally invasive surgeries of Ivor-Lewis and Mckeown

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LinkDoc Technology (Beijing) Co. Ltd.

INDUSTRY

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yang Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yang Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

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China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status

Henan cancer hospital

Zhengzhou, Henan, China

Site Status

Tongji Hospital Affiliated to Huazhong Technology Hospital

Wuhan, Hubei, China

Site Status

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Site Status

Xi'an Tangdu Hospital

Xi'an, Shaanxi, China

Site Status

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status

Huaxi Hospital Affiliated to Sichuan University

Chengdu, Sichuan, China

Site Status

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

Site Status

First Hospital Affiliated to Medical College, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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Zhang T, Hou X, Li Y, Fu X, Liu L, Xu L, Liu Y. Effectiveness and safety of minimally invasive Ivor Lewis and McKeown oesophagectomy in Chinese patients with stage IA-IIIB oesophageal squamous cell cancer: a multicentre, non-interventional and observational study. Interact Cardiovasc Thorac Surg. 2020 Jun 1;30(6):812-819. doi: 10.1093/icvts/ivaa038.

Reference Type DERIVED
PMID: 32285107 (View on PubMed)

Other Identifiers

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301-EC-01

Identifier Type: -

Identifier Source: org_study_id

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