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Detection of Anastomotic Leakage After Esophageal Surgery

NCT ID: NCT00642525

Last Updated: 2008-03-25

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

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-10-31

Brief Summary

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Anastomotic leakage is a major complication in esophageal surgery. Although contrast swallow is the current standard to exclude anastomotic leakage postoperatively, endoscopy may be superior. This is the first study to compare radiographic contrast study and endoscopy for the identification of local complications after subtotal esophagectomy.

Detailed Description

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This prospective, blinded, intraindividual controlled study will be conducted with patients with transthoracic esophagectomy due to esophageal cancer. A radiographic contrast study will be performed prior to endoscopy at the 5th to 7th postoperative day. The investigators will not be aware of the results of the corresponding examination. Sensitivity, specificity and feasibility of the radiologic and endoscopic evaluation of the esophageal substitute will be compared.

Conditions

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Esophageal Cancer Anastomotic Leakage

Keywords

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detection of anastomotic leakage esophageal resection diagnostic safety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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A

A prospective, blinded, intraindividual controlled study is conducted with patients with transthoracic esophagectomy due to esophageal cancer. A radiographic contrast study is performed prior to endoscopy at the 5th to 7th postoperative day.

Group Type EXPERIMENTAL

Contrast swallow radiography, endoscopy

Intervention Type PROCEDURE

Contrast swallow radiography is performed using water soluble contrast medium Esophagoscopy is performed according to standard safety guidelines

Interventions

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Contrast swallow radiography, endoscopy

Contrast swallow radiography is performed using water soluble contrast medium Esophagoscopy is performed according to standard safety guidelines

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with primary esophageal cancer undergoing transthoracic esophagectomy.

Exclusion Criteria

* no transthoracic resection
* no primary anastomosis
* recurrent disease
* refusal to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Department of Surgery, University of Heidelberg

Locations

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Department of Surgery, University of Heidelberg

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Endoray

Identifier Type: -

Identifier Source: org_study_id