Impact of the Techniques for Intrathoracic Esophagogastric Anastomosis on Outcome in Ivor-Lewis Oesophagectomy
This trial is active, not recruiting.
|Treatments||side-to-side stapled esophagogastric anastomosis, circular-stapled esophagogastric anastomosis|
|Phase||phase 2/phase 3|
|Sponsor||Tianjin Medical University Cancer Institute and Hospital|
|Start date||January 2011|
|End date||November 2016|
|Trial size||40 participants|
|Trial identifier||NCT01242124, TMU-CIH-ECC-001|
The purpose of this study is to determine the safety and efficacy of the side-to-side stapled intrathoracic esophagogastric anastomosis in Ivor-Lewis Oesophagectomy.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Long and short outcome related with anastomoses
time frame: 3 year
Quality of life and function outcomes
time frame: 3 year
Male or female participants from 18 years up to 80 years old.
Inclusion Criteria: - Cancer of the distal esophagus or gastroesophageal junction confirmed by biopsy (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) clinical stage I, II, or III. - Received no previous treatment for esophageal cancer - Adequate bone marrow, liver and kidney function - Patients must be able to understand the nature consent of the study and give written informed consent. Exclusion Criteria: - Age < 18 years - History of significant heart disease - Inoperable on the basis of co-existent medical problems
|Official title||Randomized Study of Intrathoracic Side-to-side Stapled Esophagogastric Anastomosis Versus Circular-Stapled Technique in Ivor-Lewis Oesophagectomy|
|Principal investigator||YU zhen tao, M.D., Ph.D.|
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