NCT00642525

Detection of Anastomotic Leakage After Esophageal Surgery

Radiologic vs. Endoscopic Evaluation of the Conduit After Esophageal Resection: a Prospective, Blinded, Intraindividual Controlled Diagnostic Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Esophageal Cancer
• Anastomotic Leakage

Interventions

Type	Name	Description
PROCEDURE	Contrast swallow radiography, endoscopy	Contrast swallow radiography is performed using water soluble contrast medium Esophagoscopy is performed according to standard safety guidelines

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-09-01
• Completion: 2007-10-01
• First posted: 2008-03-25
• Last updated: 2008-03-25

Locations

1 site across 1 country: Germany