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      Upper GI tract

      Eso-SPONGE®

      Endoluminal vacuum therapy for the treatment and prevention of anastomotic leakages, and for the treatment of perforations, in the upper GI tract.

      Product image of Eso-SPONGE®

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      Vacuum therapy to treat anastomotic leakages and perforations in the upper GI

      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. Now also the endoluminal vacuum therapy for the upper gastrointestinal is available – Eso-SPONGE®.

      Anastomotic leakage is one of the most dreaded complications after esophagectomy, with an incidence reported to up to 30%, [1-10] and a high morbidity and mortality associated. [1-10] Patients with conditions such as calcification of arteries, heart failure, hypertension, renal insufficiency, obesity or diabetes have an increased risk of anastomotic leakage after esophagectomy. [11], [12], [13] For these patients there is the option to use Eso-SPONGE® to prevent the development of anastomotic leakages.

       

      Indications

      • Treatment of anastomotic leaks or perforations in the upper gastrointestinal tract* by means of negative pressure including intraluminal or intracavitary therapy of paraoesophageal and mediastinal septic focus or localised abscesses endoscopically accessible.
      • New: Preventive therapy to reduce the risk of anastomotic leaks in the upper gastrointestinal tract*.

      *The upper GI tract refers to the oesophagus, stomach and duodenum, endoscopically accessible within the range of the overtube length.

      12.3 % - 13.6 %

      12.3 % - 13.6 %

      Leakage rate in cervical anastomosis [11], [12]

      2.9 % - 9.3 %

      2.9 % - 9.3 %

      Leakage rate in thoracic anastomosis [11], [12]

      How it works

      The basic principle of Eso-SPONGE® vacuum therapy consist of inserting an open-pored sponge into the leakage cavity or in the endoluminal area or the defect using a flexible endoscope. A drainage tube connected to the sponge is routed through the nose and connected to a low vacuum pump. Through the application of negative pressure, effective continuous drainage is achieved and a build up of secretion avoided. The sponge induces cleaning away of fibrin coatings as well as inducing granulation tissue growth to close the defect. 

      Product picture of the Eso-SPONGE® kit
      Animation about Endo-SPONGE® endoluminal vacuum therapy in the colorectal area

      How to use

      Endoluminal vacuum therapy for the treatment of anastomotic leakages and perforations in the upper GI tract.

      Procedure step by step and recommended placement

      close
      Illustration: The wound cavity should be measured with an appropriate endoscope. Cut the sponge slightly smaller than the cavity.
      Illustration: Push the overtube over the endoscope and introduce it using the endoscope as a guide until the tapered end is near the end of the cavity, leaving enough space for the sponge to deploy.
      Illustration: After leaving the overtube in the required position, place the drain of the sponge inside the pusher and introduce the sponge, previously impregnated with sterile hydrogel based on glycerol, through the overtube.
      Illustration: Push the Eso-SPONGE® to the mark with the pusher. The sponge is now at the end of the overtube (uncut sponge).
      Illustration: Advance gently until the sponge is expelled from the overtube, the resistance will fade once the sponge is released. Withdraw the overtube and pusher together.
      Illustration: The sponge will now expand in the leakage cavity. Check the position of the sponge using the endoscope to make sure that the sponge has not migrated and apply appropriate correction by means of endoscopic grasping forceps if necessary.
      Illustration: Transnasal channelling – Feed a 16 CH gastric tube in through the nose and out through the mouth. Cut off the atraumatic tip.
      Illustration: Connect the drain to the gastric tube in front of the mouth. Pull the stomach tube together with the drain back through the nose.
      Illustration: Disconnect the gastric tube. The drain is now transnasally channelled. (!) Remove of the sponge only through the mouth and never through the nose. (!)
      Illustration: Place the sponge preferentially in the cavity created by the leak or perforation: Intracavitary positioning.
      When intracavitary placement is challenging or not possible it is an option to place the sponge in the lumen in front of the defect: Intraluminal positioning. [14], [30]

      Preventive use of Eso-SPONGE®

      Endoluminal vacuum therapy for the prevention of anastomotic leakages in the upper GI tract.

      Illustration of the preventive use of Eso-SPONGE®
      • Follow the insertion system as described in "How to use" steps 1 to 6 placing the end of the overtube at the anastomosis site.
      • Release the Eso-SPONGE®, so that the sponge must be positioned at the anastomosis site.
      • The drainage can be positioned transnasally (see "How to use" steps 7 to 9).
      • Connect the device to the vacuum source, low vacuum pump from MTG.
      • Apply a continuous negative pressure of 75 mmHg as previously described.
      • Leave the sponge for 4 to 6 days and retire the sponge.

      Connection to the vacuum source

      How to use the variable speed medical vacuum pump MV 1 (MTG Sulzbach, Germany – distributed by B. Braun).

      close
      Illustration: a) The redon drain must be introduced in the Y-connector to the minimum depth marked by dashed line. b) The connection of the secretion bottle must be introduced in the Y connector to the minimum depth marked by dashed line.
      Illustration: Connect the filter using a Luer Lock to the pump. Then attach the cylinder hose from the secretion bottle to the filter.

      Clinical evidence

      Endoluminal vacuum therapy for the treatment of oesophageal anastomotic leakage

      According to the Robert Koch Institute (RKI), the number of new cases suffering of a esophageal carcinoma has doubled since 1990 in Germany. The older age groups were more affected. Taking into account an unchanged morbidity rate and survival rate a further increase of 10-year prevalence rate is expected in the coming years to 10.500 patients.

      Negative pressure to treat anastomotic leakages and perforations in the upper GI has recently demostrated potential to become the new standard of care for these patients. [8], [10]

      Patient benefits

      Vacuum therapy for the upper GI

      • Endoluminal Vacuum Therapy (EVT) is a feasible, safe and high efficient approach to treat anastomotic leaks and perforations within the upper GI. [8-10], [15-34]
      • EVT is used as the first method of choice for oesophageal leaks or perforations already in several hospitals. [8], [10], [15-31]
      Male patient in a hospital with a female doctor laughing together
      • The mean treatment duration time reported is less than 30 days. [8], [9], [16], [20], [24], [29], [36-39]
      • Contribute significantly to the reduction of morbidity and mortality of the patients. [8-10], [15-33], [35], [36]
      • Well tolerated with good short- and long-term clinical outcomes. [8-10], [15-33], [35], [36]

      Product information

      Eso-SPONGE®

      Minimally invasive method for the treatment and prevention of anastomotic leakage

      Are you interested in learning more about Eso-SPONGE® endoluminal vacuum therapy?

      Endoluminal Vacuum Therapy contact form

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      [2] Heits N, Egberts JH, Schniewind B, Hampe J, Becker T, Schafmayer C. Endoscopic-Vacuum-Therapy in Esophgageous Perforations and Anastomotic Leakages after Esophagectomy. The Best Treatment Option to Solve a Major Complication in Upper GI-Surgery? Ann Thorac Surg. 2014 Mar;97(3):1029-35.

      [3] Holscher AH, Vallbohmer D, Brabende J. The prevention and management of perioperative complications. Best Pract Res Clin Gastroenterol. 2006;20(5):907-23.

      [4] Schaheen L, Blackmon SH, Nason KS, Optimal approach to the management of intrathoracic esophageal leak following esophagectomy: a systematic review. Am J Surg, 2014. 208(4): p. 536-43.

      [5] Sdralis EIK, Petousis S, Rashid F, Charalabopoulos A. Epidemiology, diagnosis, and management of esophageal perforations: systematic review. Dis Esophagus. 2017 Aug1;30(8):1-6.

      [6] Di Leo M, Maselli R, Ferrara EC, Poliani L, Al Awadhi S, Repici A. Endoscopic Management of Benign Esophageal Ruptures and Leaks. Curr Treat Options Gastroenterol. 2017 Jun;15(2):268-84.

      [7] Blencowe NS, Strong S, McNair AG, Brookes ST, Crosby T, Griffin SM, Blazeby JM. Reporting of short-term clinical outcomes after esophagectomy: a systematic review. Ann Surg, 2012 Apr;255(4):658-66.

      [8] Kuehn F, Schiffmann L, Janisch F, Schwandner F, Alsfasser G, Gock M, Klar E. Surgical Endoscopic Vacuum Therapy for Defects of the Upper Gastrointestinal Tract. J Gastrointest Surg. 2016 Feb;20(2):237-43.

      [9] Heits N, Bernsmeier A, Reichert B, Hauser C, Hendricks A, Seifert D, Richter F, Schafmayer C, Ellrichmann M, Schniewind B, Hampe J, Becker T, Egberts JH. Long-term quality of life after endovac-therapy in anastomotic leakages after esophagectomy. J Thorac Dis. 2018 Jan;10(1):228-40.

      [10] Morell B, Murray F, Vetter D, Bueter M, Gubler C. Endoscopic vacuum therapy (EVT) for early infradiaphragmal leakage after bariatric surgery-outcomes of six consecutive cases in a single institution. Langenbecks Arch Surg. 2019 Feb;404(1):115-21.

      [11] Kassis ES, Kosinski AS, Ross P Jr, Koppes KE, Donahue JM, Daniel VC. Predictors of anastomotic leak after esophagectomy: an analysis of the society of thoracic surgeons general thoracic database. Ann Thorac Surg. 2013 Dec;96(6):1919-26.

      [12] van Rossum PSN, Jeene PM, Rozema T, Braam PM, Lips IM, Muller K, van Kampen D, Vermeulen BD, Homs MYV, Oppedijk V, Berbée M, C C M Hulshof M, Siersema PD, El Sharouni SY. Patient-reported outcomes after external beam radiotherapy versus brachytherapy for palliation of dysphagia in esophageal cancer: a matched comparison of two prospective trials. Radiother Oncol. 2020 Oct 13:S0167-8140(20)30845-8.

      [13] Zhang SS, Yang H, Luo KJ, Huang QY, Chen JY, Yang F, Cai XL, Xie X, Liu QW, Bella AE, Hu RG, Wen J, Hu Y, Fu JH. The impact of body mass index on complication and survival in resected oesophageal cancer: a clinical-based cohort and meta-analysis. Br J Cancer. 2013 Nov 26;109(11):2894-903.

      [14] Kuehn F, Janisch F, Schwandner F, Alsfasser G, Schiffmann L, Gock M, Klar E. Endoscopic Vacuum Therapy in Colorectal Surgery. J Gastrointest Surg. 2016 Feb;20(2):328-34.

      [15] Schniewind B, Schafmayer C, Voehrs G, Egberts J, von Schoenfels W, Rose T, Kurdow R, Arlt A, Ellrichmann M, Jürgensen 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.

      [16] Smallwood NR, Fleshman JW, Leeds SG, Burdick JS. The use of endoluminal vacuum (E-Vac) therapy in the management of upper gastrointestinal leaks and perforations. Surg Endosc. 2016 Jun;30(6):2473-80.

      [17] Laukoetter MG, Mennigen R, Neumann PA, Dhayat S, Horst G, Palmes D, Senninger N, Vowinkel T. Successful closure of defects in the upper gastrointestinal tract by endoscopic vacuum therapy (EVT): a prospective cohort study. Surg Endosc. 2017 Jun;31(6):2687-96.

      [18] Brangewitz M, Voigtländer 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.

      [19] Mennigen R, Harting C, Lindner K, Vowinkel T, Rijcken E, Palmes D, Senninger N, Laukoetter MG. Comparison of Endoscopic Vacuum Therapy Versus Stent for Anastomotic Leak After Esophagectomy. J Gastrointest Surg. 2015 Jul;19(7):1229-35.

      [20] Gubler C, Vetter D, Schmidt HM, Müller PC, Morell B, Raptis D, Gutschow CA. Preemptive endoluminal vacuum therapy to reduce anastomotic leakage after esophagectomy: a game-changing approach? Dis Esophagus. 2019 Jul 1;32(7):doy126.

      [21] Neumann PA, Mennigen R, Palmes D, Senninger N, Vowinkel T, Laukoetter MG. Pre-emptive endoscopic vacuum therapy for treatment of anastomotic ischemia after esophageal resections. Endoscopy. 2017 May;49(5):498-503.

      [22] Möschler O, Nies C, Mueller MK. Endoscopic vacuum therapy for esophageal perforations and leakages. Endosc Int Open. 2015 Dec;3(6):E554-8.

      [23] Hwang JJ, Jeong YS, Park YS, Yoon H, Shin CM, Kim N, Lee DH. Comparison of Endoscopic Vacuum Therapy and Endoscopic Stent Implantation With Self-Expandable Metal Stent in Treating Postsurgical Gastroesophageal Leakage. Medicine (Baltimore). 2016 Apr;95(16):e3416.

      [24] Bludau M, Fuchs HF, Herbold T, Maus MKH, Alakus H, Popp F, Leers JM, Bruns CJ, Hölscher AH, Schröder W, Chon SH. Results of endoscopic vacuum-assisted closure device for treatment of upper GI leaks. Surg Endosc. 2018 Apr;32(4):1906-14.

      [25] Valli PV, Mertens JC, Kröger A, Gubler C, Gutschow C, Schneider PM, Bauerfeind P. Stent-over-sponge (SOS): a novel technique complementing endosponge therapy for foregut leaks and perforations. Endoscopy. 2018 Feb;50(2):148-53.

      [26] Rausa E, Asti E, Aiolfi A, Bianco F, Bonitta G, Bonavina L. Comparison of endoscopic vacuum therapy versus endoscopic stenting for esophageal leaks: systematic review and meta-analysis. Dis Esophagus. 2018 Nov 1;31(11).

      [27] Pournaras DJ, Hardwick RH, Safranek PM, Sujendran V, Bennett J, Macaulay GD, Hindmarsh A. Endoluminal Vacuum Therapy (E-Vac): A Treatment Option in Oesophagogastric Surgery. World J Surg. 2018 Aug;42(8):2507-11.

      [28] 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.

      [29] 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.

      [30] Loske G, Schorsch T, Dahm C, Martens E, Müller C. Iatrogenic perforation of esophagus successfully treated with Endoscopic Vacuum Therapy (EVT). Endosc Int Open. 2015 Dec;3(6):E547-51.

      [31] Ooi G, Burton P, Packiyanathan A, Loh D, Chen R, Shaw K, Brown W, Nottle P. Indications and efficacy of endoscopic vacuum-assisted closure therapy for upper gastrointestinal perforations. ANZ J Surg. 2018 Apr;88(4):E257-63.

      [32] Alakkari A, Sood R, Everett SM, Rembacken BJ, Hayden J, Sarela A, Mohammed N. First UK experience of endoscopic vacuum therapy for the management of oesophageal perforations and postoperative leaks. Frontline Gastroenterol. 2019 Apr;10(2):200-203.

      [33] Chon SH, Toex U, Plum PS, Fuchs C, Kleinert R, Bruns C, Goeser T. Successful closure of a gastropulmonary fistula after esophagectomy using the Apollo Overstitch and endoscopic vacuum therapy. Endoscopy. 2018 Jul; 50(7):E149-50.

      [34] Herbold T, Chon SH, Grimminger P, Maus MKH, Schmidt H, Fuchs H, Brinkmann S, Bludau M, Gutschow C, Schröder W, Hölscher AH, Leers JM. Endoscopic Treatment of Transesophageal Echocardiography-Induced Esophageal Perforation. J Laparoendosc Adv Surg Tech A. 2018 Apr;28(4):422-28.

      [35] Glatz T, Fischer A, Hoeppner J, Thimme R, Walker C, Richter-Schrag HJ. Vacuum sponge therapy using the pull-through technique via a percutaneous endoscopic gastrostomy to treat iatrogenic duodenal perforation. Endoscopy. 2015;47 Suppl 1:E567-8.

      [36] Loske G. Endoscopic negative pressure therapy of the upper gastrointestinal tract. Chirurg. 2019 Jan;90 (Suppl 1):1-6.

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