NCT00686569

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

1.5 years

First QC Date

May 27, 2008

Last Update Submit

August 3, 2014

Conditions

Anastomotic LeakageEsophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • Early detection of postoperative complications

    30 days postoperative

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoin oesophageal resection for cancer

You may qualify if:

  • Histological verified oesophageal or cardia cancer

You may not qualify if:

  • Lack of consent, otherwise none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Surgical department A, Odense University Hospital

Odense, 5000, Denmark

Location

Odense University Hospital, surgical department A

Odense C, DK-5000, Denmark

Location

Related Publications (1)

  • Ellebaek 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.2013.09.026. Epub 2014 Jan 16.

    PMID: 24656920RESULT

MeSH Terms

Conditions

Anastomotic LeakEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Niels Qvist, Professor

    Department of Surgery

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 30, 2008

Study Start

April 1, 2007

Primary Completion

October 1, 2008

Study Completion

February 1, 2009

Last Updated

August 5, 2014

Record last verified: 2014-08

Locations

DK(2)