Impact of the Techniques for Intrathoracic Esophagogastric Anastomosis on Outcome in Ivor-Lewis Oesophagectomy

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01242124
• Other study ID #: TMU-CIH-ECC-001
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: November 13, 2010
• Last updated: December 21, 2015
• Start date: January 2011
• Est. completion date: December 2016

Study information

• Verified date: September 2010
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Procedure:
• side-to-side stapled esophagogastric anastomosis
20 patients of distal esophageal cancer receive side-to-side stapled esophagogastric anastomosis in Ivor-Lewis oesophagectomy
• circular-stapled esophagogastric anastomosis
20 patients of distal esophageal cancer receive circular-stapled esophagogastric anastomosis in Ivor-Lewis oesophagectomy

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long and short outcome related with anastomoses	Include anastomotic leakage,anastomotic stricture,regurgitation,heartburn, dumping syndrome and anastomoses diameter.	3 year	Yes
Secondary	Quality of life and function outcomes		3 year	Yes