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Randomized Study of Intrathoracic Side-to-side Stapled Esophagogastric Anastomosis Versus Circular-Stapled Technique in Ivor-Lewis Oesophagectomy


Phase 2/Phase 3
18 Years
80 Years
Open (Enrolling)
Both
Esophageal Cancer

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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

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