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

Esophageal Cancer Clinical Trial

Official title:

Mediastinal Microdialysis in Early Diagnosis of Anastomotic Leakage After Resection for Esophageal Cancer: Preliminary Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686569
• Other study ID #: S-20070062
• 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

Related Conditions & MeSH terms

• Anastomotic Leak
• Anastomotic Leakage
• Esophageal Cancer
• Esophageal Neoplasms

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