Radiologic vs. Endoscopic Evaluation of the Conduit After Esophageal Resection: a Prospective, Blinded, Intraindividual Controlled Diagnostic Study.
18 Years
N/A
Both
Esophageal Cancer, Anastomotic Leakage
Trial Information
Radiologic vs. Endoscopic Evaluation of the Conduit After Esophageal Resection: a Prospective, Blinded, Intraindividual Controlled Diagnostic Study.
This prospective, blinded, intraindividual controlled study will be conducted with patients
with transthoracic esophagectomy due to esophageal cancer. A radiographic contrast study
will be performed prior to endoscopy at the 5th to 7th postoperative day. The investigators
will not be aware of the results of the corresponding examination. Sensitivity, specificity
and feasibility of the radiologic and endoscopic evaluation of the esophageal substitute
will be compared.
Inclusion Criteria:
- Patients with primary esophageal cancer undergoing transthoracic esophagectomy.
Exclusion Criteria:
- no transthoracic resection
- no primary anastomosis
- recurrent disease
- refusal to participate
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
Outcome Measure:
Detection of anastomotic leakage
Outcome Time Frame:
5-7 days after surgical procedure
Safety Issue:
Yes
Authority:
Ethics Commission, Heidelberg: Germany
Study ID:
Endoray
NCT ID:
NCT00642525
Start Date:
January 2006
Completion Date:
October 2007
Related Keywords:
- Esophageal Cancer
- Anastomotic Leakage
- detection of anastomotic leakage
- esophageal resection
- diagnostic safety
- Esophageal Diseases
- Esophageal Neoplasms
- Anastomotic Leak
Name | Location |
|---|
