Mediastinal Microdialysis in Patients With Oesophageal or Cardia Cancer Treated by Resection

NCT ID: NCT00686569

Last Updated: 2014-08-05

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

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-02-28

Brief Summary

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Postoperative anastomotic leakage is a serious complication in patients with oesophageal or cardia cancer. Early diagnosis and treatment are mandatory. The primary aim of the present study is to investigate the clinical use of mediastinal microdialysis and whether is able to detect anastomotic leakage prior to the development of clinical symptoms.

Detailed Description

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Patients undergoing oesophageal or cardia resection for cancer are monitored by mediastinal microdialysis during the postoperative period. Subcutaneous microdialysis serves as a control. Samples are collected every 4-hour. Samples will be analyzed continuously but the results will not be included in the clinical evaluation of the patient.

A total of 30 patients will be included in this pilot study. The results of the mediastinal microdialyses will be compared with the clinical course in each patient. The results form the uncomplicated courses will be used to define the normal variations in mediastinal microdialysis. This will be compared to results from patients with various complications.

Conditions

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Anastomotic Leakage Esophageal Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Histological verified oesophageal or cardia cancer

Exclusion Criteria

* Lack of consent, otherwise none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Niels Qvist

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Niels Qvist, Professor

Role: STUDY_CHAIR

Department of Surgery

Locations

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Surgical department A, Odense University Hospital

Odense, , Denmark

Site Status

Odense University Hospital, surgical department A

Odense C, , Denmark

Site Status

Countries

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Denmark

References

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Ellebaek M, Qvist N, Fristrup C, Mortensen MB. Mediastinal microdialysis in the diagnosis of early anastomotic leakage after resection for cancer of the esophagus and gastroesophageal junction. Am J Surg. 2014 Sep;208(3):397-405. doi: 10.1016/j.amjsurg.2013.09.026. Epub 2014 Jan 16.

Reference Type RESULT
PMID: 24656920 (View on PubMed)

Other Identifiers

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S-20070062

Identifier Type: -

Identifier Source: org_study_id

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