Detection of Anastomotic Leakage After Esophageal Surgery

Heidelberg University

Status: Completed

Conditions: Esophageal Cancer; Anastomotic Leakage

Treatments: Procedure: Contrast swallow radiography, endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT00642525

Endoray

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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55 participants in 1 patient group

A

Experimental group

Description:

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.

Treatment:

Procedure: Contrast swallow radiography, endoscopy