Detection of Anastomotic Leakage After Esophageal Surgery

Sponsor

Heidelberg University (Other)

Overall Status

Completed

CT.gov ID

NCT00642525

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer Anastomotic Leakage	Procedure: Contrast swallow radiography, endoscopy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Investigator)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A 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

Arm

Intervention/Treatment

Experimental: A

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

Outcome Measures

Primary Outcome Measures

Detection of anastomotic leakage [5-7 days after surgical procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with primary esophageal cancer undergoing transthoracic esophagectomy.

Exclusion Criteria:

no transthoracic resection
no primary anastomosis
recurrent disease
refusal to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Surgery, University of Heidelberg	Heidelberg		Germany	69120

Sponsors and Collaborators

Heidelberg University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00642525

Other Study ID Numbers:

Endoray

First Posted:

Mar 25, 2008

Last Update Posted:

Mar 25, 2008

Last Verified:

Mar 1, 2008

Keywords provided by , ,

detection of anastomotic leakage

esophageal resection

diagnostic safety

Additional relevant MeSH terms:

Anastomotic Leak

Study Results

No Results Posted as of Mar 25, 2008