K22.3 K91.81
Conditions
Interventions
Group 1: The VAC stent is a combination of the two previous, usually single-use treatments. The new procedure is a vacuum-assisted stent system for occluding a leak in the esophagus. In this system, t
Sponsors
Universitätsklinikum Köln
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Spontanous perforation of the esophagus Iatrogene perforation of the esophagus Postoperative leakage of the esophagus
Exclusion criteria
Exclusion criteria: Endoscopic inaccessibility of the affected section Full anticoagulation with INR> 1.5 and / or PTT> 50 sec or platelets <20,000 / µl (after therapeutic correction is an inclusion possible) Unstable patients with severe septicemia Disease after clinical evaluation an immediate surgery required ileus with constant vomiting (after Gastric tube and gastric emptying is a Inclusion possible)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technique - % of patients with successful implantation of VACStent [ Time Frame: 1 year ] % of patients with successful implantation of VACStent | — |
Secondary
| Measure | Time frame |
|---|---|
| - Avoidance / elimination of sepsis - Morphological healing of insufficiency - Complication detection (stent dislocation, Arrosion of tissue structures in the Abscess cavity / in the esophagus / paraesophageal / bleeding | — |
Countries
Germany
Contacts
Public ContactSeung-Hun Chon
Universitätsklinikum Köln
Outcome results
None listed