Clinical trial NCT03428074: A Observational Study to Compare Effectiveness and Safety of the Surgeries in Patients With Esophageal Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Keywords: Chinese, esophageal cancer, surgeries of Ivor-Lewis/Mckeown
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: LinkDoc Technology (Beijing) Co. Ltd.
First posted: 2018-02-09
Enrollment: 1862
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pathogically diagnosed IA-IIIB patients with esophageal cancer who received the surgeries of Ivor-Lewis and Mckeown

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

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.

Eligibility 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)

Primary outcomes:
measure: Overall survivals in patients with esophageal cancer who received surgeries
timeFrame: 2010 - 2017
Secondary outcomes:
measure: Death rates within 30 days after surgeries
timeFrame: 2010 - 2017
Other outcomes:
measure: Incidence of complications after surgeries
timeFrame: 2010 - 2017
measure: Incision R0 rates
timeFrame: 2010 - 2017
measure: Percentages of patients who received lymphadenectomy
timeFrame: 2010 - 2017
measure: Extents of lymph metastases
timeFrame: 2010 - 2017
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Zhengzhou
country: China
facility: Henan cancer hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Huazhong Technology Hospital
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Xi'an
country: China
facility: Xi'an Tangdu Hospital
state: Shaanxi
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Chengdu
country: China
facility: Huaxi Hospital Affiliated to Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Hangzhou
country: China
facility: First Hospital Affiliated to Medical College, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Chinese PLA General Hospital
name: Yang Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.