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

Tianjin Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Esophageal Cancer

Treatments: Procedure: circular-stapled esophagogastric anastomosis; Procedure: side-to-side stapled esophagogastric anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT01242124

TMU-CIH-ECC-001

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

side-to-side stapled esophagogastric anastomosis arm

Experimental group

Treatment:

Procedure: side-to-side stapled esophagogastric anastomosis

circular-stapled esophagogastric anastomosis arm

Active Comparator group

Treatment:

Procedure: circular-stapled esophagogastric anastomosis