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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03428074
Enrollment
1862
Registered
2018-02-09
Start date
2017-12-01
Completion date
2018-03-30
Last updated
2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

Chinese, esophageal cancer, surgeries of Ivor-Lewis/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.

Interventions

PROCEDURESurgeries

Minimally invasive surgeries of Ivor-Lewis and Mckeown

Sponsors

LinkDoc Technology (Beijing) Co. Ltd.
CollaboratorINDUSTRY
Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Overall survivals in patients with esophageal cancer who received surgeries2010 - 2017Overall survivals in patients with esophageal cancer who received surgeries categorised by tumor biological characteristics

Secondary

MeasureTime frameDescription
Death rates within 30 days after surgeries2010 - 2017Death rates within 30 days after surgeries categorised by tumor biological characteristics

Other

MeasureTime frameDescription
Incidence of complications after surgeries2010 - 2017Incidence of complications after surgeries categorised by tumor biological characteristics
Incision R0 rates2010 - 2017Incision R0 rates categorised by tumor biological characteristics
Percentages of patients who received lymphadenectomy2010 - 2017Percentages of patients who received lymphadenectomy categorised by tumor biological characteristics
Extents of lymph metastases2010 - 2017Extents of lymph metastases categorised by tumor biological characteristics

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026