Mediastinal Microdialysis in Patients With Oesophageal or Cardia Cancer Treated by Resection
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Mediastinal Microdialysis in Early Diagnosis of Anastomotic Leakage After Resection for Esophageal Cancer: Preliminary Results|
- Early detection of postoperative complications [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2007|
|Study Completion Date:||February 2009|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686569
|Surgical department A, Odense University Hospital|
|Odense, Denmark, 5000|
|Odense University Hospital, surgical department A|
|Odense C, Denmark, DK-5000|
|Study Chair:||Niels Qvist, Professor||Department of Surgery|