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Leakage After EsophagectomyNCT02662777

Eso-Sponge Registry

An observational study of Leakage After Esophagectomy and Leakage After Gastrectomy, run by Aesculap AG at 17 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Eso-SPONGE® vacuum treatment
Type of treatment
Medical device
How many people
108 participants
Where
17 sitesGermany
Study dates
Jan 2015to 31 Dec 2023
How long will I take part?
2 Weeks
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with anastomotic leakages after esophageal resection or gastrectomy and spontaneous or iatrogenic esophageal perforations.

Who may be able to join

  • Endoscopic vacuum therapy (EVT) of anastomotic leakage after esophageal resection or spontaneous or iatrogenic perforations
  • age > 18 years
  • written informed consent

Who cannot join

  • none

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Germany17 sites

  • Zentralklinik Bad Berka

    Bad Berka, 99437

  • Augusta-Kliniken GmbH

    Bochum, North Rhine-Westphalia, 44791

  • Krankenhaus der Augustinerinnen

    Cologne, 50678

  • St. Johannes-Hospital Dortmund

    Dortmund, North Rhine-Westphalia, 44137

  • Sankt Katharinen Krankenhaus

    Frankfurt am Main, Hesse, 60389

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 70106

  • Wald-Klinikum Gera

    Gera, Thuringia, 07548

  • Universitätsmedizin Greifswald

    Greifswald, 17475

  • Städtisches Krankenhaus Heinsberg

    Heinsberg, 52525

  • Klinikum Herford

    Herford, Hesse, 32049

  • EVK Herne

    Herne, North Rhine-Westphalia, 44623

  • Universitätsklinikum Kiel

    Kiel, Schleswig-Holstein, 24105

  • Asklepios Klinik

    Lich, Hesse, 35423

  • Klinikum Lüneburg, Klinik für Allgemein-, Viszeral- & Thoraxchirurgie

    Lüneburg, Lower Saxony, 21339

  • Siloah St. Trudpert Klinikum

    Pforzheim, Baden-Wurttemberg, 75179

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Klinikum Wilhelmshaven

    Wilhelmshaven, Lower Saxony, 26389

Other trials in Germany

About this study

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.

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.

Read the 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.

Being tested
Eso-SPONGE® vacuum treatment
Keywords
esophageal anastomosis leakage, endoscopic vacuum therapy, esophageal perforation, upper gastrointestinal tract, esophageal leak, endoscopy
Medical subject headings
Esophageal Perforation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eso-SPONGE® vacuum treatmentDevice

Study groups in NCT02662777
Study groupRoleWhat they receive
Eso-SPONGE® vacuum treatmentleakage after esophagectomy and gastrectomy, perforation of the esophagus
Receives: Device: Eso-SPONGE® vacuum treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Healing rate of the esophageal anastomosis leakage or esophageal perforation

    Reduction of the cavity, endoscopic vacuum therapy no longer necessary

    Measured: until day of discharge (approximately 2 weeks)

Secondary outcomes (5)

  1. Number of Eso-SPONGE® changes

    Measured: until day of discharge (approximately 2 weeks)

  2. Total number of sponges used

    Total number of Eso-SPONGE® units used until day of discharge

    Measured: until day of discharge (approximately 2 weeks)

  3. Average replacement intervals

    Period of time between exchange of ESO-Sponge®

    Measured: until day of discharge (approximately 2 weeks)

  4. Duration of endoscopic vacuum therapy

    Number of days during which Eso-SPONGE® was applied

    Measured: until day of discharge (approximately 2 weeks)

  5. Complication Rate

    Number of Complications during endoscopic vacuum treatment (e.g. death, re-operations, stenosis, pneumonia, peritonitis, mediastinitis)

    Measured: until day of discharge (approximately 2 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2016 (estimated)
  2. Study startJan 2015
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
108 participants (actual)
Target duration
2 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT02662777
Sponsor's protocol ID
AAG-O-H-1317
Status last verified
Aug 2024
First submitted
19 Jan 2016
Last updated
14 Aug 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Ahrens M, Schulte T, Egberts J, Schafmayer C, Hampe J, Fritscher-Ravens A, Broering DC, Schniewind B. Drainage of esophageal leakage using endoscopic vacuum therapy: a prospective pilot study. Endoscopy. 2010 Sep;42(9):693-8. doi: 10.1055/s-0030-1255688. Epub 2010 Aug 30.

    PubMed 20806153

  • Bludau M, Holscher AH, Herbold T, Leers JM, Gutschow C, Fuchs H, Schroder W. Management of upper intestinal leaks using an endoscopic vacuum-assisted closure system (E-VAC). Surg Endosc. 2014 Mar;28(3):896-901. doi: 10.1007/s00464-013-3244-5. Epub 2013 Oct 23.

    PubMed 24149851

  • Brangewitz M, Voigtlander T, Helfritz FA, Lankisch TO, Winkler M, Klempnauer J, Manns MP, Schneider AS, Wedemeyer J. Endoscopic closure of esophageal intrathoracic leaks: stent versus endoscopic vacuum-assisted closure, a retrospective analysis. Endoscopy. 2013 Jun;45(6):433-8. doi: 10.1055/s-0032-1326435. Epub 2013 Jun 3.

    PubMed 23733727

  • Gubler C, Schneider PM, Bauerfeind P. Complex anastomotic leaks following esophageal resections: the new stent over sponge (SOS) approach. Dis Esophagus. 2013 Aug;26(6):598-602. doi: 10.1111/dote.12005. Epub 2012 Nov 30.

    PubMed 23199232

  • Heits N, Stapel L, Reichert B, Schafmayer C, Schniewind B, Becker T, Hampe J, Egberts JH. Endoscopic endoluminal vacuum therapy in esophageal perforation. Ann Thorac Surg. 2014 Mar;97(3):1029-35. doi: 10.1016/j.athoracsur.2013.11.014. Epub 2014 Jan 18.

    PubMed 24444874

  • Kuehn F, Schiffmann L, Rau BM, Klar E. Surgical endoscopic vacuum therapy for anastomotic leakage and perforation of the upper gastrointestinal tract. J Gastrointest Surg. 2012 Nov;16(11):2145-50. doi: 10.1007/s11605-012-2014-3. Epub 2012 Sep 5.

    PubMed 22948839

  • Lenzen H, Negm AA, Erichsen TJ, Manns MP, Wedemeyer J, Lankisch TO. Successful treatment of cervical esophageal leakage by endoscopic-vacuum assisted closure therapy. World J Gastrointest Endosc. 2013 Jul 16;5(7):340-5. doi: 10.4253/wjge.v5.i7.340.

    PubMed 23858378

  • 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, Muller C. Intraluminal and intracavitary vacuum therapy for esophageal leakage: a new endoscopic minimally invasive approach. Endoscopy. 2011 Jun;43(6):540-4. doi: 10.1055/s-0030-1256345. Epub 2011 Mar 29.

    PubMed 21448855

  • 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, Muller C. Endoscopic intracavitary vacuum sponge therapy of anastomotic leakage in the proximal colon after right-sided colectomy. Endoscopy. 2010;42 Suppl 2:E171-2. doi: 10.1055/s-0029-1244177. Epub 2010 Jun 16. No abstract available.

    PubMed 20556720

  • Loske G, Schorsch T, Muller C. Endoscopic intracavitary vacuum therapy of Boerhaave's syndrome: a case report. Endoscopy. 2010;42 Suppl 2:E144-5. doi: 10.1055/s-0029-1244092. Epub 2010 Apr 19. No abstract available.

    PubMed 20405387

  • Loske G, Schorsch T, Muller C. Endoscopic vacuum sponge therapy for esophageal defects. Surg Endosc. 2010 Oct;24(10):2531-5. doi: 10.1007/s00464-010-0998-x. Epub 2010 Mar 24.

    PubMed 20333402

  • Loske G, Schorsch T, Mueller CT. Endoscopic intraluminal vacuum therapy of duodenal perforation. Endoscopy. 2010;42 Suppl 2:E109. doi: 10.1055/s-0029-1243947. Epub 2010 Mar 19. No abstract available.

    PubMed 20306395

Questions about this trial

What is this clinical trial studying?

An observational study of Leakage After Esophagectomy and Leakage After Gastrectomy, run by Aesculap AG at 17 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Healing rate of the esophageal anastomosis leakage or esophageal perforation (time frame: until day of discharge (approximately 2 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02662777, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024; AzTrials last refreshed its copy on 28 Oct 2026.

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