Detection of Anastomotic Leakage After Esophageal Surgery

Not Applicable

Completed

• Conditions: Esophageal Cancer; Anastomotic Leakage
• Interventions: Procedure: Contrast swallow radiography, endoscopy

• Registration Number: NCT00642525
• Lead Sponsor: Heidelberg University

Brief 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.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2007-09
• Study Completion: 2007-10
• Status Verified: 2008-03
• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-03-19
• Last Update Submitted: 2008-03-19
• Study First Posted: 2008-03-25
• Last Update Posted: 2008-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Patients with primary esophageal cancer undergoing transthoracic esophagectomy.

Exclusion Criteria

• no transthoracic resection
• no primary anastomosis
• recurrent disease
• refusal to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Contrast swallow radiography, endoscopy	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.

Primary Outcome Measures

Name	Time	Method
Detection of anastomotic leakage	5-7 days after surgical procedure

Trial Locations

Locations (1)

Department of Surgery, University of Heidelberg; 🇩🇪 Heidelberg, Germany