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| Sponsored by: |
University of Heidelberg |
|---|---|
| Information provided by: | University of Heidelberg |
| ClinicalTrials.gov Identifier: | NCT00642525 |
Purpose
Anastomotic leakage is a major complication in esophageal surgery. Although contrast swallow is the current standard to exclude anastomotic leakage postoperatively, endoscopy may be superior. This is the first study to compare radiographic contrast study and endoscopy for the identification of local complications after subtotal esophagectomy.
| Condition | Intervention |
|---|---|
|
Esophageal Cancer Anastomotic Leakage |
Procedure: Contrast swallow radiography, endoscopy |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Single Blind (Investigator), Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Radiologic vs. Endoscopic Evaluation of the Conduit After Esophageal Resection: a Prospective, Blinded, Intraindividual Controlled Diagnostic Study. |
| Enrollment: | 55 |
| Study Start Date: | January 2006 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
A prospective, blinded, intraindividual controlled study is conducted with patients with transthoracic esophagectomy due to esophageal cancer. A radiographic contrast study is performed prior to endoscopy at the 5th to 7th postoperative day.
|
Procedure: Contrast swallow radiography, endoscopy
Contrast swallow radiography is performed using water soluble contrast medium Esophagoscopy is performed according to standard safety guidelines
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Department of Surgery, University of Heidelberg ( Jens Werner, MD Professor of Surgery ) |
| Study ID Numbers: | Endoray |
| Study First Received: | March 19, 2008 |
| Last Updated: | March 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00642525 History of Changes |
| Health Authority: | Ethics Commission, Heidelberg: Germany |
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detection of anastomotic leakage esophageal resection diagnostic safety |
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Digestive System Neoplasms Digestive System Diseases Esophageal Disorder Gastrointestinal Diseases Head and Neck Neoplasms |
Esophageal Neoplasms Gastrointestinal Neoplasms Esophageal Cancer Esophageal Diseases |
|
Neoplasms Neoplasms by Site Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Head and Neck Neoplasms Esophageal Neoplasms Gastrointestinal Neoplasms Esophageal Diseases |
