C15 C16
Conditions
Interventions
Group 1: In case of an leakage of an esophago-enteric anastomosis after extended gastrectomy or esophagectomy an endoscopic placement of a self-expanding Stent (metal or plastic) over the anastomotic
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Histological confirmed esophageal or gastric cancer or a similar surgically treated malignancy (e.g. GIST) 2.Esophagectomy or gastrectomy with an intrathiracic or intraabdominal esophago-enteric anastomosis 3.Radiologically or endoscopically verified leakage 4.Clinical symptoms or elevated inflammatory lab results due to the leakage 5.Age over 18 years 6.Ability to understand and willingness to consent to formal requirements for study participation 7.Written informed consent
Exclusion criteria
Exclusion criteria: 1. Macroscopical incomplete resection(R2) 2.Endoscopically verified conduit necrosis 3.Leakage size over 2/3 of circumference4.Early leakage (<48 hours after surgery) 5. Pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of leakage healing (radiologically or endoscopical confirmed) or hospital discharge on day 44 after primary surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hospitalization 2. Rate of treatment failure 3. Rate of a need of surgical revision and its kind 4. Complications 5.Mortality 6.ICU-time 7.SOFA-Score 8.Artificial ventilation time 9.Quality of life 10.Duration of leakage therapy 11.Time until endoscopical verified healing 12.Time until perusal nutrition 13. Direct costs 14. Symptomatic stenosis rate after 1 year | — |
Countries
Germany
Contacts
Public ContactMichael Tachezy
Universitätsklinikum Hamburg-Eppendorf
Outcome results
None listed