Clinical trial NCT02662777: Eso-Sponge Registry
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leakage After Esophagectomy
Leakage After Gastrectomy
Perforation of the Esophagus
Keywords: esophageal anastomosis leakage
endoscopic vacuum therapy
esophageal perforation
upper gastrointestinal tract
esophageal leak
endoscopy
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: Universitätsklinikum Kiel
First posted: 2016-01-26
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with anastomotic leakages after esophageal resection or gastrectomy and spontaneous or iatrogenic esophageal perforations.

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.

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

Primary outcomes:
measure: Healing rate of the esophageal anastomosis leakage or esophageal perforation
timeFrame: until day of discharge (approximately 2 weeks)
Secondary outcomes:
measure: Number of Eso-SPONGE® changes
timeFrame: until day of discharge (approximately 2 weeks)
measure: Total number of sponges used
timeFrame: until day of discharge (approximately 2 weeks)
measure: Average replacement intervals
timeFrame: until day of discharge (approximately 2 weeks)
measure: Duration of endoscopic vacuum therapy
timeFrame: until day of discharge (approximately 2 weeks)
measure: Complication Rate
timeFrame: until day of discharge (approximately 2 weeks)
Other outcomes:
Locations:
city: Pforzheim
country: Germany
facility: Siloah St. Trudpert Klinikum
state: Baden-Württemberg
city: Frankfurt
country: Germany
facility: Sankt Katharinen Krankenhaus
state: Hessen
city: Herford
country: Germany
facility: Klinikum Herford
state: Hessen
city: Lich
country: Germany
facility: Asklepios Klinik
state: Hessen
city: Lüneburg
country: Germany
facility: Klinikum Lüneburg, Klinik für Allgemein-, Viszeral- & Thoraxchirurgie
state: Niedersachsen
city: Wilhelmshaven
country: Germany
facility: Klinikum Wilhelmshaven
state: Niedersachsen
city: Bochum
country: Germany
facility: Augusta-Kliniken GmbH
state: Nordrhein-Westfalen
city: Dortmund
country: Germany
facility: St. Johannes-Hospital Dortmund
state: Nordrhein-Westfalen
city: Herne
country: Germany
facility: EVK Herne
state: Nordrhein-Westfalen
city: Kiel
country: Germany
facility: Universitätsklinikum Kiel
state: Schleswig-Holstein
city: Gera
country: Germany
facility: Wald-Klinikum Gera
state: Thüringen
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Heinsberg
country: Germany
facility: Städtisches Krankenhaus Heinsberg
city: Köln
country: Germany
facility: Krankenhaus der Augustinerinnen
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
Study officials:
affiliation: Universitätsklinikum Kiel
name: Clemens Schafmayer, Prof. Dr.
role: STUDY_CHAIR
References:
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