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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642525
• Other study ID #: Endoray
• Status: Completed
• Phase: N/A
• First received: March 19, 2008
• Last updated: March 19, 2008
• Start date: January 2006
• Est. completion date: October 2007

Study information

• Verified date: March 2008
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethics Commission, Heidelberg: Germany
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Procedure:
• Contrast swallow radiography, endoscopy
Contrast swallow radiography is performed using water soluble contrast medium Esophagoscopy is performed according to standard safety guidelines

Locations

Country	Name	City	State
Germany	Department of Surgery, University of Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of anastomotic leakage		5-7 days after surgical procedure	Yes