Anastomotic Leakage, Esophageal Cancer
Conditions
Keywords
detection of anastomotic leakage, esophageal resection, diagnostic safety
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.
Interventions
PROCEDUREContrast swallow radiography, endoscopy
Contrast swallow radiography is performed using water soluble contrast medium Esophagoscopy is performed according to standard safety guidelines
Sponsors
Heidelberg University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with primary esophageal cancer undergoing transthoracic esophagectomy.
Exclusion criteria
* no transthoracic resection * no primary anastomosis * recurrent disease * refusal to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection of anastomotic leakage | 5-7 days after surgical procedure |
Countries
Germany
Outcome results
None listed