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

Esophageal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03428074
• Other study ID #: 301-EC-01
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: May 2018
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1862
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Huaxi Hospital Affiliated to Sichuan University	Chengdu	Sichuan
China	First Hospital Affiliated to Medical College, Zhejiang University	Hangzhou	Zhejiang
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Tianjin Chest Hospital	Tianjin	Tianjin
China	Tongji Hospital Affiliated to Huazhong Technology Hospital	Wuhan	Hubei
China	Xi'an Tangdu Hospital	Xi'an	Shaanxi
China	Henan cancer hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	LinkDoc Technology (Beijing) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of complications after surgeries	Incidence of complications after surgeries categorised by tumor biological characteristics	2010 - 2017
Other	Incision R0 rates	Incision R0 rates categorised by tumor biological characteristics	2010 - 2017
Other	Percentages of patients who received lymphadenectomy	Percentages of patients who received lymphadenectomy categorised by tumor biological characteristics	2010 - 2017
Other	Extents of lymph metastases	Extents of lymph metastases categorised by tumor biological characteristics	2010 - 2017
Primary	Overall survivals in patients with esophageal cancer who received surgeries	Overall survivals in patients with esophageal cancer who received surgeries categorised by tumor biological characteristics	2010 - 2017
Secondary	Death rates within 30 days after surgeries	Death rates within 30 days after surgeries categorised by tumor biological characteristics	2010 - 2017