Trial Information
Randomized Study of Intrathoracic Side-to-side Stapled Esophagogastric Anastomosis Versus Circular-Stapled Technique in Ivor-Lewis Oesophagectomy
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
Long and short outcome related with anastomoses
Outcome Description:
Include anastomotic leakage,anastomotic stricture,regurgitation,heartburn, dumping syndrome and anastomoses diameter.
Outcome Time Frame:
3 year
Safety Issue:
Yes
Principal Investigator
YU zhen tao, M.D., Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Tianjin Medical University Cancer Institute and Hospital
Authority:
China: Ethics Committee
Study ID:
TMU-CIH-ECC-001
NCT ID:
NCT01242124
Start Date:
January 2011
Completion Date:
December 2015
Related Keywords:
- Esophageal Cancer
- Esophageal Diseases
- Esophageal Neoplasms