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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00686569
Other study ID # S-20070062
Secondary ID
Status Completed
Phase N/A
First received May 27, 2008
Last updated August 3, 2014
Start date April 2007
Est. completion date February 2009

Study information

Verified date August 2014
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 2009
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Histological verified oesophageal or cardia cancer

Exclusion Criteria:

- Lack of consent, otherwise none

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
Denmark Surgical department A, Odense University Hospital Odense
Denmark Odense University Hospital, surgical department A Odense C

Sponsors (1)

Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Ellebæk 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.201 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Early detection of postoperative complications 30 days postoperative Yes
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