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Detection of Anastomotic Leakage After Esophageal Surgery

Primary Purpose

Esophageal Cancer, Anastomotic Leakage

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Contrast swallow radiography, endoscopy

About this trial

This is an interventional diagnostic trial for Esophageal Cancer focused on measuring detection of anastomotic leakage, esophageal resection, diagnostic safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with primary esophageal cancer undergoing transthoracic esophagectomy.

Exclusion Criteria:

no transthoracic resection
no primary anastomosis
recurrent disease
refusal to participate

Sites / Locations

Department of Surgery, University of Heidelberg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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.

Outcomes

Primary Outcome Measures

Detection of anastomotic leakage

Secondary Outcome Measures

Full Information

NCT ID

NCT00642525

First Posted

March 19, 2008

Last Updated

March 19, 2008

Sponsor

Heidelberg University

1. Study Identification

Unique Protocol Identification Number

NCT00642525

Brief Title

Detection of Anastomotic Leakage After Esophageal Surgery

Official Title

Radiologic vs. Endoscopic Evaluation of the Conduit After Esophageal Resection: a Prospective, Blinded, Intraindividual Controlled Diagnostic Study.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

September 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Heidelberg University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer, Anastomotic Leakage

Keywords

detection of anastomotic leakage, esophageal resection, diagnostic safety

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

Non-Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Contrast swallow radiography, endoscopy

Intervention Description

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

Primary Outcome Measure Information:

Title

Detection of anastomotic leakage

Time Frame

5-7 days after surgical procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with primary esophageal cancer undergoing transthoracic esophagectomy. Exclusion Criteria: no transthoracic resection no primary anastomosis recurrent disease refusal to participate

Facility Information:

Facility Name

Department of Surgery, University of Heidelberg

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Detection of Anastomotic Leakage After Esophageal Surgery

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