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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Niels Qvist, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00686569
First received: May 27, 2008
Last updated: August 3, 2014
Last verified: August 2014
  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 Odense University Hospital:

Primary Outcome Measures:
  • Early detection of postoperative complications [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686569

Locations
Denmark
Surgical department A, Odense University Hospital
Odense, Denmark, 5000
Odense University Hospital, surgical department A
Odense C, Denmark, DK-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
Study First Received: May 27, 2008
Last Updated: August 3, 2014
Health Authority: Denmark: Ethics Committee

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

ClinicalTrials.gov processed this record on November 25, 2014