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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00686569
First Posted: May 30, 2008
Last Update Posted: August 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Niels Qvist, Odense University Hospital
  Purpose
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.

Condition
Anastomotic Leakage Esophageal Cancer

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Niels Qvist, Odense University Hospital:

Primary Outcome Measures:
  • Early detection of postoperative complications [ Time Frame: 30 days postoperative ]

Enrollment: 40
Study Start Date: April 2007
Study Completion Date: February 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoin oesophageal resection for cancer
Criteria

Inclusion Criteria:

  • Histological verified oesophageal or cardia cancer

Exclusion Criteria:

  • Lack of consent, otherwise none
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00686569


Locations
Denmark
Odense University Hospital, surgical department A
Odense C, Denmark, DK-5000
Surgical department A, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Study Chair: Niels Qvist, Professor Department of Surgery
  More Information

Publications:
Responsible Party: Niels Qvist, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00686569     History of Changes
Other Study ID Numbers: S-20070062
First Submitted: May 27, 2008
First Posted: May 30, 2008
Last Update Posted: August 5, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Esophageal Neoplasms
Anastomotic Leak
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Postoperative Complications
Pathologic Processes