Detection of Anastomotic Leakage After Esophageal Surgery

Esophageal Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

• NCT number: NCT00642525
• Study type: Interventional
• Source: Heidelberg University
• Status: Completed
• Phase: N/A
• Start date: January 2006
• Completion date: October 2007