Detection of Anastomotic Leakage After Esophageal Surgery

Heidelberg University55 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Esophageal Cancer Anastomotic Leakage

Interventions

Contrast swallow radiography, endoscopyPROCEDURE

Contrast swallow radiography is performed using water soluble contrast medium Esophagoscopy is performed according to standard safety guidelines

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with primary esophageal cancer undergoing transthoracic esophagectomy. Exclusion Criteria: * no transthoracic resection * no primary anastomosis * recurrent disease * refusal to participate

Locations (1)

Department of Surgery, University of Heidelberg

Heidelberg, Germany

Outcomes

Primary Outcomes

Detection of anastomotic leakage

Time frame: 5-7 days after surgical procedure

Data from ClinicalTrials.gov

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