Overview

This trial is active, not recruiting.

Condition esophageal cancer
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

Summary

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

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
side-to-side stapled esophagogastric anastomosis
20 patients of distal esophageal cancer receive side-to-side stapled esophagogastric anastomosis in Ivor-Lewis oesophagectomy
(Active Comparator)
circular-stapled esophagogastric anastomosis
20 patients of distal esophageal cancer receive circular-stapled esophagogastric anastomosis in Ivor-Lewis oesophagectomy

Primary Outcomes

Measure
Long and short outcome related with anastomoses
time frame: 3 year

Secondary Outcomes

Measure
Quality of life and function outcomes
time frame: 3 year

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Tianjin Medical University Cancer Institute and Hospital.