NCT02662777

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 19, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

9 years

First QC Date

January 19, 2016

Last Update Submit

August 13, 2024

Conditions

Leakage After EsophagectomyLeakage After GastrectomyPerforation of the Esophagus

Keywords

esophageal anastomosis leakageendoscopic vacuum therapyesophageal perforationupper gastrointestinal tractesophageal leakendoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Number of Eso-SPONGE® changes

    until day of discharge (approximately 2 weeks)

  • Total number of sponges used

    until day of discharge (approximately 2 weeks)

  • Average replacement intervals

    until day of discharge (approximately 2 weeks)

  • Duration of endoscopic vacuum therapy

    until day of discharge (approximately 2 weeks)

  • Complication Rate

    until day of discharge (approximately 2 weeks)

Study Arms (1)

Eso-SPONGE® vacuum treatment

leakage after esophagectomy and gastrectomy, perforation of the esophagus

Device: Eso-SPONGE® vacuum treatment

Interventions

Eso-SPONGE® vacuum treatmentDEVICE
Eso-SPONGE® vacuum treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Siloah St. Trudpert Klinikum

Pforzheim, Baden-Wurttemberg, 75179, Germany

Location

Sankt Katharinen Krankenhaus

Frankfurt am Main, Hesse, 60389, Germany

Location

Klinikum Herford

Herford, Hesse, 32049, Germany

Location

Asklepios Klinik

Lich, Hesse, 35423, Germany

Location

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

Lüneburg, Lower Saxony, 21339, Germany

Location

Klinikum Wilhelmshaven

Wilhelmshaven, Lower Saxony, 26389, Germany

Location

Augusta-Kliniken GmbH

Bochum, North Rhine-Westphalia, 44791, Germany

Location

St. Johannes-Hospital Dortmund

Dortmund, North Rhine-Westphalia, 44137, Germany

Location

EVK Herne

Herne, North Rhine-Westphalia, 44623, Germany

Location

Universitätsklinikum Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Wald-Klinikum Gera

Gera, Thuringia, 07548, Germany

Location

Zentralklinik Bad Berka

Bad Berka, 99437, Germany

Location

Krankenhaus der Augustinerinnen

Cologne, 50678, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 70106, Germany

Location

Universitätsmedizin Greifswald

Greifswald, 17475, Germany

Location

Städtisches Krankenhaus Heinsberg

Heinsberg, 52525, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Related Publications (36)

  • 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.

    PMID: 20806153BACKGROUND

  • 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.

    PMID: 24149851BACKGROUND

  • 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.

    PMID: 23733727BACKGROUND

  • 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.

    PMID: 23199232BACKGROUND

  • 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.

    PMID: 24444874BACKGROUND

  • 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.

    PMID: 22948839BACKGROUND

  • 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.

    PMID: 23858378BACKGROUND

  • Loske G, Schorsch T. [Endoscopic intraluminal vacuum therapy of complete esophageal-jejunal anastomotic rupture: a case report.] Viszeralmedizin. 2011; 27: 166-168.

    BACKGROUND

  • 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.

    PMID: 21448855BACKGROUND

  • Loske G, Schorsch T, Müller C. Intraluminale und intracavitäre Vakuumtherapie bei Ösophagusdefekten. Z Gastroenterol. 2010; 48: 19.

    BACKGROUND

  • Loske G, Schorsch T, Müller C. Erste Erfahrungen mit der intraluminalen endoskopischen Vakuumschwammtherapie zur Behandlung von Duodenaldefekten. Z Gastroenterol. 2010; 48: 55

    BACKGROUND

  • 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.

    PMID: 20556720BACKGROUND

  • 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.

    PMID: 20405387BACKGROUND

  • 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.

    PMID: 20333402BACKGROUND

  • 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.

    PMID: 20306395BACKGROUND

  • Loske G, Schorsch T. [Intraluminale Vakuumtherapie - ein innovativer endoskopischer Ansatz zur Therapie von duodenalen Leckagen.] Endoscopy. 2010; 23 (4). 267-269.

    BACKGROUND

  • Loske G, Muller C. Endoscopic vacuum-assisted closure of upper intestinal anastomotic leaks. Gastrointest Endosc. 2009 Mar;69(3 Pt 1):601-2; author reply 602. doi: 10.1016/j.gie.2008.06.058. No abstract available.

    PMID: 19231507BACKGROUND

  • Loske G, Muller C. [Vacuum therapy of an esophageal anastomotic leakage--a case report]. Zentralbl Chir. 2009 Jun;134(3):267-70. doi: 10.1055/s-0028-1098764. Epub 2009 Apr 22. German.

    PMID: 19387934BACKGROUND

  • Murphy T, Jobe BA. Endoluminal management of anastomotic dehiscence after esophagectomy: an increasing quiver of options reflects the difficulty in realizing a definitive therapy. Gastrointest Endosc. 2010 Feb;71(2):387-9. doi: 10.1016/j.gie.2009.09.033. No abstract available.

    PMID: 20152315BACKGROUND

  • Saadi A, Perentes JY, Gonzalez M, Tempia AC, Wang Y, Demartines N, Ris HB, Krueger T. Vacuum-assisted closure device: a useful tool in the management of severe intrathoracic infections. Ann Thorac Surg. 2011 May;91(5):1582-9. doi: 10.1016/j.athoracsur.2011.01.018. Epub 2011 Feb 26.

    PMID: 21354551BACKGROUND

  • Schniewind B, Schafmayer C, Voehrs G, Egberts J, von Schoenfels W, Rose T, Kurdow R, Arlt A, Ellrichmann M, Jurgensen C, Schreiber S, Becker T, Hampe J. Endoscopic endoluminal vacuum therapy is superior to other regimens in managing anastomotic leakage after esophagectomy: a comparative retrospective study. Surg Endosc. 2013 Oct;27(10):3883-90. doi: 10.1007/s00464-013-2998-0. Epub 2013 May 25.

    PMID: 23708716BACKGROUND

  • Schniewind B, Schafmayer C, Both M, Arlt A, Fritscher-Ravens A, Hampe J. Ingrowth and device disintegration in an intralobar abscess cavity during endosponge therapy for esophageal anastomotic leakage. Endoscopy. 2011;43 Suppl 2 UCTN:E64-5. doi: 10.1055/s-0030-1255799. Epub 2011 Feb 21. No abstract available.

    PMID: 21341185BACKGROUND

  • Schorsch T, Muller C, Loske G. Pancreatico-gastric anastomotic insufficiency successfully treated with endoscopic vacuum therapy. Endoscopy. 2013;45 Suppl 2 UCTN:E141-2. doi: 10.1055/s-0032-1326260. Epub 2013 May 28. No abstract available.

    PMID: 23716102BACKGROUND

  • Schorsch T, Muller C, Loske G. Endoscopic vacuum therapy of anastomotic leakage and iatrogenic perforation in the esophagus. Surg Endosc. 2013 Jun;27(6):2040-5. doi: 10.1007/s00464-012-2707-4. Epub 2012 Dec 18.

    PMID: 23247743BACKGROUND

  • Wallstabe I, Tiedemann A, Schiefke I. Endoscopic vacuum-assisted therapy of infected pancreatic pseudocyst using a coated sponge. Endoscopy. 2012;44 Suppl 2 UCTN:E49-50. doi: 10.1055/s-0031-1291525. Epub 2012 Mar 6. No abstract available.

    PMID: 22396274BACKGROUND

  • Wallstabe I, Tiedemann A, Schiefke I. Endoscopic vacuum-assisted therapy of an infected pancreatic pseudocyst. Endoscopy. 2011;43 Suppl 2 UCTN:E312-3. doi: 10.1055/s-0030-1256643. Epub 2011 Sep 13. No abstract available.

    PMID: 21915843BACKGROUND

  • Wallstabe I, Plato R, Weimann A. Endoluminal vacuum therapy for anastomotic insufficiency after gastrectomy. Endoscopy. 2010;42 Suppl 2:E165-6. doi: 10.1055/s-0029-1244150. Epub 2010 Jun 16. No abstract available.

    PMID: 20556717BACKGROUND

  • Wallstabe I, Weimann A. Eine neue endoskopische Technik im Management der Anastomoseinsuffizienz nach Ösophaguschirurgie. Z Gastroenterol 2007; 45

    BACKGROUND

  • Wedemeyer J, Lankisch T. [Endoscopic vacuum-assisted closure]. Internist (Berl). 2013 Mar;54(3):309-14. doi: 10.1007/s00108-012-3182-7. German.

    PMID: 23430199BACKGROUND

  • Wedemeyer J, Schneider AS, Winkler M, Manns MP. Endoskopische Vakuumtherapie bei Perforationen und Anastomoseninsuffizienzen. Gastroenterologe. 2011; 6 (2): 120-123.

    BACKGROUND

  • Wedemeyer J, Brangewitz M, Kubicka S, Jackobs S, Winkler M, Neipp M, Klempnauer J, Manns MP, Schneider AS. Management of major postsurgical gastroesophageal intrathoracic leaks with an endoscopic vacuum-assisted closure system. Gastrointest Endosc. 2010 Feb;71(2):382-6. doi: 10.1016/j.gie.2009.07.011. Epub 2009 Oct 30.

    PMID: 19879566BACKGROUND

  • 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.

    BACKGROUND

  • Wedemeyer J, Schneider A, Manns MP, Jackobs S. Endoscopic vacuum-assisted closure of upper intestinal anastomotic leaks. Gastrointest Endosc. 2008 Apr;67(4):708-11. doi: 10.1016/j.gie.2007.10.064.

    PMID: 18374029BACKGROUND

  • Weidenhagen R, Hartl WH, Gruetzner KU, Eichhorn ME, Spelsberg F, Jauch KW. Anastomotic leakage after esophageal resection: new treatment options by endoluminal vacuum therapy. Ann Thorac Surg. 2010 Nov;90(5):1674-81. doi: 10.1016/j.athoracsur.2010.07.007.

    PMID: 20971288BACKGROUND

  • Wettstein M, Frieling T, Luthen R, Heintges T, Niederau C, Oette M, Vogt C, Vom Dahl S. [Endoscopic therapy for leaks in the gastrointestinal tract, the bile ducts and the pancreas]. Z Gastroenterol. 2011 Jun;49(6):740-8. doi: 10.1055/s-0031-1273422. Epub 2011 Jun 1. German.

    PMID: 21638241BACKGROUND

  • Richter F, Hendricks A, Schniewind B, Hampe J, Heits N, von Schonfels W, Reichert B, Eberle K, Ellrichmann M, Baumann P, Egberts JH, Becker T, Schafmayer C. Eso-Sponge(R) for anastomotic leakage after oesophageal resection or perforation: outcomes from a national, prospective multicentre registry. BJS Open. 2022 Mar 8;6(2):zrac030. doi: 10.1093/bjsopen/zrac030.

    PMID: 35451010RESULT

MeSH Terms

Conditions

Esophageal Perforation

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesWounds and Injuries

Study Officials

  • Clemens Schafmayer, Prof. Dr.

    Universitätsklinikum Kiel

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2016

First Posted

January 26, 2016

Study Start

January 1, 2015

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 14, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(17)