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Eso-Sponge Registry

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ClinicalTrials.gov Identifier: NCT02662777
Recruitment Status : Recruiting
First Posted : January 26, 2016
Last Update Posted : March 9, 2021
Sponsor:
Collaborator:
Universitätsklinikum Kiel
Information provided by (Responsible Party):
Aesculap AG

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.

Condition or disease Intervention/treatment
Leakage After Esophagectomy Leakage After Gastrectomy Perforation of the Esophagus Device: Eso-SPONGE® vacuum treatment

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Weeks
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.
Actual Study Start Date : January 2015
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Group/Cohort Intervention/treatment
Eso-SPONGE® vacuum treatment
leakage after esophagectomy and gastrectomy, perforation of the esophagus
Device: Eso-SPONGE® vacuum treatment



Primary Outcome Measures :
  1. Healing rate of the esophageal anastomosis leakage or esophageal perforation [ Time Frame: until day of discharge (approximately 2 weeks) ]
    Reduction of the cavity, endoscopic vacuum therapy no longer necessary


Secondary Outcome Measures :
  1. Number of Eso-SPONGE® changes [ Time Frame: until day of discharge (approximately 2 weeks) ]
  2. Total number of sponges used [ Time Frame: until day of discharge (approximately 2 weeks) ]
    Total number of Eso-SPONGE® units used until day of discharge

  3. Average replacement intervals [ Time Frame: until day of discharge (approximately 2 weeks) ]
    Period of time between exchange of ESO-Sponge®

  4. Duration of endoscopic vacuum therapy [ Time Frame: until day of discharge (approximately 2 weeks) ]
    Number of days during which Eso-SPONGE® was applied

  5. Complication Rate [ Time Frame: until day of discharge (approximately 2 weeks) ]
    Number of Complications during endoscopic vacuum treatment (e.g. death, re-operations, stenosis, pneumonia, peritonitis, mediastinitis)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with anastomotic leakages after esophageal resection or gastrectomy and spontaneous or iatrogenic esophageal perforations.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662777


Contacts
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Contact: Petra Baumann, Dr. +49-7461-95 ext 1646 petra.baumann@aesculap.de

Locations
Show Show 17 study locations
Sponsors and Collaborators
Aesculap AG
Universitätsklinikum Kiel
Investigators
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Study Chair: Clemens Schafmayer, Prof. Dr. Universitätsklinikum Kiel
Additional Information:

Publications:
Loske G, Schorsch T. [Endoscopic intraluminal vacuum therapy of complete esophageal-jejunal anastomotic rupture: a case report.] Viszeralmedizin. 2011; 27: 166-168.
Loske G, Schorsch T, Müller C. Intraluminale und intracavitäre Vakuumtherapie bei Ösophagusdefekten. Z Gastroenterol. 2010; 48: 19.
Loske G, Schorsch T, Müller C. Erste Erfahrungen mit der intraluminalen endoskopischen Vakuumschwammtherapie zur Behandlung von Duodenaldefekten. Z Gastroenterol. 2010; 48: 55
Loske G, Schorsch T. [Intraluminale Vakuumtherapie - ein innovativer endoskopischer Ansatz zur Therapie von duodenalen Leckagen.] Endoscopy. 2010; 23 (4). 267-269.
Wallstabe I, Weimann A. Eine neue endoskopische Technik im Management der Anastomoseinsuffizienz nach Ösophaguschirurgie. Z Gastroenterol 2007; 45
Wedemeyer J, Schneider AS, Winkler M, Manns MP. Endoskopische Vakuumtherapie bei Perforationen und Anastomoseninsuffizienzen. Gastroenterologe. 2011; 6 (2): 120-123.
Wedemeyer J, Helfritz FA, Brangewitz M, Winkler M, Manns MP, Schneider A. Endoskopische Vakuum-Schwamm-Therapie bei Leckagen im Verdauungstrakt . Gastrointest Endosc 2009; 23 (1): 41-45.

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Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT02662777    
Other Study ID Numbers: AAG-O-H-1317
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Aesculap AG:
esophageal anastomosis leakage
endoscopic vacuum therapy
esophageal perforation
upper gastrointestinal tract
esophageal leak
endoscopy
Additional relevant MeSH terms:
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Esophageal Perforation
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Wounds and Injuries