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

NCT ID: NCT01242124

Last Updated: 2015-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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side-to-side stapled esophagogastric anastomosis arm

Group Type EXPERIMENTAL

side-to-side stapled esophagogastric anastomosis

Intervention Type PROCEDURE

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

circular-stapled esophagogastric anastomosis arm

Group Type ACTIVE_COMPARATOR

circular-stapled esophagogastric anastomosis

Intervention Type PROCEDURE

20 patients of distal esophageal cancer receive circular-stapled esophagogastric anastomosis in Ivor-Lewis oesophagectomy

Interventions

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side-to-side stapled esophagogastric anastomosis

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

Intervention Type PROCEDURE

circular-stapled esophagogastric anastomosis

20 patients of distal esophageal cancer receive circular-stapled esophagogastric anastomosis in Ivor-Lewis oesophagectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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YU zhen tao, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Locations

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Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Other Identifiers

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TMU-CIH-ECC-001

Identifier Type: -

Identifier Source: org_study_id