A Observational Study to Compare Effectiveness and Safety of the Surgeries in Patients With Esophageal Cancer
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
1 other identifier
observational
1,862
1 country
9
Brief Summary
The study was designed to compare effectiveness and safety of the surgeries of Ivor-Lewis and Mckeown in patients with esophageal cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2017
Shorter than P25 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 5, 2018
CompletedFirst Posted
Study publicly available on registry
February 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2018
CompletedMay 21, 2018
May 1, 2018
4 months
February 5, 2018
May 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Death rates within 30 days after surgeries
2010 - 2017
Other Outcomes (4)
Incidence of complications after surgeries
2010 - 2017
Incision R0 rates
2010 - 2017
Percentages of patients who received lymphadenectomy
2010 - 2017
- +1 more other outcomes
Study Arms (2)
Patients with the surgery of Ivor-Lewis
Pathologically diagnosed IA-IIIB patients with esophageal cancer who received minimally invasive surgery of Ivor-Lewis
Patients with the surgery of Mckeown
Pathologically diagnosed IA-IIIB patients with esophageal cancer who received minimally invasive surgery of Mckeown
Interventions
Minimally invasive surgeries of Ivor-Lewis and Mckeown
Eligibility Criteria
Pathogically diagnosed IA-IIIB patients with esophageal cancer who received the surgeries of Ivor-Lewis and Mckeown
You may qualify if:
- 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;
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Henan cancer hospital
Zhengzhou, Henan, 450008, China
Tongji Hospital Affiliated to Huazhong Technology Hospital
Wuhan, Hubei, 430030, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
Xi'an Tangdu Hospital
Xi'an, Shaanxi, 710000, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Huaxi Hospital Affiliated to Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300051, China
First Hospital Affiliated to Medical College, Zhejiang University
Hangzhou, Zhejiang, 310003, China
Related Publications (1)
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.
PMID: 32285107DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yang Liu, PhD
Chinese PLA General Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 5, 2018
First Posted
February 9, 2018
Study Start
December 1, 2017
Primary Completion
March 30, 2018
Study Completion
March 30, 2018
Last Updated
May 21, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share