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

Phase 2

• Conditions: Esophageal Cancer
• Interventions: Procedure: side-to-side stapled esophagogastric anastomosis; Procedure: circular-stapled esophagogastric anastomosis

• Registration Number: NCT01242124
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-09
• Study First Submitted: 2010-11-13
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Study Start: 2011-01
• Last Update Submitted: 2015-12-21
• Last Update Posted: 2015-12-22
• Primary Completion: 2016-11
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
side-to-side stapled esophagogastric anastomosis arm	side-to-side stapled esophagogastric anastomosis	-
circular-stapled esophagogastric anastomosis arm	circular-stapled esophagogastric anastomosis	-

Primary Outcome Measures

Name	Time	Method
Long and short outcome related with anastomoses	3 year	Include anastomotic leakage,anastomotic stricture,regurgitation,heartburn, dumping syndrome and anastomoses diameter.

Secondary Outcome Measures

Name	Time	Method
Quality of life and function outcomes	3 year

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy; 🇨🇳 Tianjin, Tianjin, China