Eso-Sponge Registry

Study Overview
=================
Brief Summary
-----------------
This international, prospective and multicenter registry was designed to collect clinical evidence for the endoscopic vacuum treatment using Eso-SPONGE® for anastomotic leakage after esophageal resection or iatrogenic or spontaneous esophageal perforation.

Detailed Description
-----------------
Anastomotic Leakages or other defects in the upper gastrointestinal tract can have serious consequences for the affected patients. Different parameters, like the size, location, time to diagnosis of the lesion, but also the general condition of the patient, have a significant influence on the clinical outcome of the patient. Often this situation is accompanied by symptoms of sepsis and a significant morbidity rate with corresponding substantial mortality rate. For this reason the treatment of this clinical situation is often a challenge for the clinician. Besides surgical examination and the endoscopic stent system, good experiences have been obtained with the Endo-SPONGE® therapy for the lower gastrointestinal tract. In the future the endoluminal vacuum therapy for the upper gastrointestinal is available, too, with Eso-SPONGE®. Eso-SPONGE® represent an innovative therapy concept for the treatment of this problem in the upper gastrointestinal tract, which can contribute significantly to the reduction of morbidity and mortality of the patients. The overall success rate of endoscopic esophageal vacuum therapy in the literature ranges from 80-100%. Currently only cohort studies including a small number of patients have been performed and published. Therefore an international, prospective and multicenter registry was designed to collect clinical evidence for Eso-SPONGE treatment concept in a large population under daily clinical routine.

Official Title
-----------------
International, Prospective, Multicenter Registry Designed to Collect Clinical Evidence for Endoscopic Vacuum Treatment Using Eso-SPONGE® for Anastomotic Leakage After Esophageal Resection or Iatrogenic or Spontaneous Esophageal Perforation.

Conditions
-----------------
Leakage After Esophagectomy, Leakage After Gastrectomy, Perforation of the Esophagus

Intervention / Treatment
-----------------
* Device: Eso-SPONGE® vacuum treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Endoscopic vacuum therapy (EVT) of anastomotic leakage after esophageal resection or spontaneous or iatrogenic perforations age > 18 years written informed consent Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eso-SPONGE® vacuum treatment<br>leakage after esophagectomy and gastrectomy, perforation of the esophagus | Device: Eso-SPONGE® vacuum treatment<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing rate of the esophageal anastomosis leakage or esophageal perforation | Reduction of the cavity, endoscopic vacuum therapy no longer necessary | until day of discharge (approximately 2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Eso-SPONGE® changes |  | until day of discharge (approximately 2 weeks) | 
| Total number of sponges used | Total number of Eso-SPONGE® units used until day of discharge | until day of discharge (approximately 2 weeks) | 
| Average replacement intervals | Period of time between exchange of ESO-Sponge® | until day of discharge (approximately 2 weeks) | 
| Duration of endoscopic vacuum therapy | Number of days during which Eso-SPONGE® was applied | until day of discharge (approximately 2 weeks) | 
| Complication Rate | Number of Complications during endoscopic vacuum treatment (e.g. death, re-operations, stenosis, pneumonia, peritonitis, mediastinitis) | until day of discharge (approximately 2 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
esophageal anastomosis leakage, endoscopic vacuum therapy, esophageal perforation, upper gastrointestinal tract, esophageal leak, endoscopy