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Evidence - Eso-SPONGE® – Endoluminal vacuum treatment in staple line failure and perforations of the upper GI tract

  1. Literature summary

    Endoscopic vacuum therapy of esophageal staple line failure and perforation

    While mortality rates following esophageal resection have decreased significantly in recent decades, management of transmural esophageal defects in staple failure and perforation continues to be a challenge (1, 2). The incidence rates reported in the literature for leakage following esophageal resection vary considerably, ranging from 1% to 30%. The leakage rates for cervical anastomoses range from 1% to 25% (3 - 7), for intrathoracic anastomoses less than 10% (8 - 12) and following gastrectomy with resection of the distal esophagus around 10% (13).

    The etiology of esophageal perforations is primarily iatrogenic and can be attributed to the increasing performance of endoscopic procedures such as interventional resections and dilations (14 - 16).

    Fatal courses in staple line failures and perforations are predominantly due to the development of mediastinitis with clinical sepsis (17). Early initiation of appropriate treatment is crucial for the prognosis. If treatment is delayed for more than 24 hours after leakage onset, the mortality rate is more than 20%. In a meta-analysis from 2013, the mean perforation-related mortality rate was nearly 12% (18).

    Treatment strategies in esophageal leakage

    All treatment measures aim to close the esophageal defect and drain the extraluminal septic focus (19, 20). A strictly non-surgical approach—systemic antibiotics, parenteral nutrition, and tube drainage—is possible in selected cases (21).

    The defect may be closed surgically (suture, refashioning the anastomosis, resection with closure of the esophageal stump) or endoscopically by insertion of self-expanding metal or plastic stents (20, 22), by clip closure (23), or by fibrin sealant (24, 25). Defects were most often bridged by stents (26).

    The extraluminal septic focus is drained by external percutaneous drains placed either during revision surgery or by interventional radiology (27).

    Endoscopic vacuum therapy is a novel therapeutic option in esophageal leaks (28). It has already been employed successfully for many years as an intracorporeal modality in the treatment of rectal staple line failure (29). Endoscopic sponge placement allows placement of a polyurethane sponge drain under vision at any position accessible by colonoscopy or gastroscopy (30, 31). Sponge placement can be strictly intraluminal for defect sealing or intracavitary through the defect into an extraluminal wound cavity (32).

    Outcome in endoscopic vacuum therapy of esophageal leaks

    Endoscopic vacuum therapy in upper GI tract leakage was first reported in 2007. Disregarding case series of less than five patients, the current literature lists a total of 88 patients who underwent the vacuum procedure to repair esophageal defects.

    The success rate for the different study groups ranged from 84.4% to 100% with a mortality of 10% to 16.7%. The mean duration of treatment was reported as 12.1–24.4 days. The mean number of sponge system replacements required was 3.9–9.8 (33–38).

    To date, there have only been rare reports of any notable treatment-associated complications, such as bleeding due to vascular erosion and formation of esophagobronchial fistulas (34, 39).

    Two retrospective studies compared the therapeutic outcomes of surgical revision, stenting, and vacuum treatment in esophageal staple line failure (34, 40). Both studies found vacuum therapy to be superior to stenting. For example, the healing rate for endoscopic vacuum therapy was 84.4% versus 53.8% in endoscopic stenting. One of the studies compared the mortality following revision surgery or stenting versus vacuum therapy. In the group treated by revision surgery or stenting, 50% and 42%, respectively, died during their hospital stay, compared with only 12% of patients treated by endoscopic vacuum therapy.

    The current study findings suggest that endoscopic vacuum therapy is an effective, simple, and minimally invasive modality in the treatment of esophageal leakage.

  2. Ongoing trials on this topic

  3. References on this topic

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    2: Martin LW, Swisher SG, Hofstetter W et al (2005) Intrathoracic leaks following esophagectomy are no longer associated with increased mortality. Ann Surg 242:392–399
    3: Zieren HU, Muller JM, Pichlmaier H. (1993) Prospective randomized study of one- or two-layer anastomosis following oesophageal resection and cervical oesophagogastrostomy. Br J Surg, 80 (5): 608–611.
    4: Gelfand GA, Finley RJ, Nelems B, In- culet R, Evans KG, Fradet G. (1992) Transhiatal esophagectomy for carcinoma of the esophagus and cardia. Experience with 160 cases. Arch Surg, 127 (10): 1164–1167; discussion 1167–1168.
    5: Heitmiller RF, Fischer A, Liddicoat JR. (1999) Cervical esophagogastric anastomosis: results following esophagectomy for carcinoma. Dis Esophagus, 12 (4): 264–269.
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    7: Korst RJ, Port JL, Lee PC, Altorki NK. (2005) Intrathoracic manifestations of cervical anastomotic leaks after transthoracic esophagectomy for carcinoma. Ann Thorac Surg, 80 (4): 1185–1190.
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    11: Paterson IM, Wong J. (1989) Anastomotic leakage: an avoidable complication of Lewis-Tanner oesophagectomy. Br J Surg, 76 (2): 127–129.
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    13: Schmid A, Thybusch A, Kremer B, Henne-Bruns D. (2000) Differential effects of radical D2-lymphadenectomy and splenectomy in surgically treated gastric cancer patients. Hepatogastroenterology, 47 (32): 579–585.
    14: Brinster CJ, Singhal S, Lee L et al (2004) Evolving options in the management of esophageal perforation. Ann Thorac Surg 77:1475–1483
    15: Vidarsdottir H, Blondal S, Alfredsson H et al (2010) Oesophageal perforations in Iceland: a whole population study on incidence, aetiology and surgical outcome. Thorac Cardiovasc Surg 58:476–480
    16: Merchea A, Cullinane DC, Sawyer MD et al (2010) Esophagogastroduodenoscopy-associated gastrointestinal perforations: a single-center experience. Surgery 148:876–880
    17: Sepesi B, Raymond DP, Peters JH (2010) Esophageal perforation: surgical, endoscopic and medical management strategies. Curr Opin Gastroenterol 26:379–383
    18: Biancari F, D’Andrea V, Paone R et al (2013) Current treatment and outcome of esophageal perforations in adults: systematic review and meta-analysis of 75 studies. World J Surg 37:1051–1059
    19: Sepesi B, Raymond DP, Peters JH (2010) Esophageal perforation: surgical, endoscopic and medical management strategies. Curr Opin Gastroenterol 26:379–383
    20: Vallböhmer D, Holscher AH, Holscher M et al (2010) Options in the management of esophageal perforation: analysis over a 12-year period 4. Dis Esophagus 23:185−190
    21: Holscher AH, Fetzner UK, Bludau M, Leers J (2011) Complications and management of complications in oesophageal surgery. Zentralbl Chir 136:213–223
    22: Fischer A, Thomusch O, Benz S et al (2006) Nonoperative treatment of 15 benign esophageal perforations with self-expandable covered metal stents. Ann Thorac Surg 81:467–472
    23: Nishiyama N, Mori H, Kobara H et al (2013) Efficacy and safety of over-the-scope clip: including complications after endoscopic submucosal dissection. World J Gastroenterol 19:2752–2760
    24: Lautermann J, Radecke K, Sudhoff H et al (2007) Management of iatrogenic esophageal perforations. HNO 55:723–728
    25: Pross M, Manger T, Reinheckel T et al (2000) Endoscopic treatment of clinically symptomatic leaks of thoracic esophageal anastomoses. Gastrointest Endosc 51:73–76
    26: Biancari F, Gudbjartsson T, Mennander A et al (2013) Treatment of esophageal perforation in octogenarians: a multicenter study. Dis Esophagus. DOI 10.1111/dote.12148
    27: Freeman RK, Vyverberg A, Ascioti AJ (2011) Esophageal stent placement for the treatment of acute intrathoracic anastomotic leak after esophagectomy. Ann Thorac Surg 92:204–208
    28: Loske G, Schorsch T, Muller C (2010) Endoscopic vacuum sponge therapy for esophageal defects. Surg Endosc 24:2531–2535
    29: Weidenhagen R, Gruetzner KU, Wiecken T et al (2008) Endoscopic vacuum-assisted closure of anastomotic leakage following anterior resection of the rectum: a new method. Surg Endosc 22:1818–1825
    30: Loske G, Schorsch T, Mueller CT (2010) Endoscopic intraluminal vacuum therapy of duodenal perforation. Endoscopy 42(Suppl 2):E109
    31: Loske G, Schorsch T, Mueller CT (2010) Endoscopic intracavitary vacuum sponge therapy of anastomotic leakage in the proximal colon after right-sided colectomy. Endoscopy 42(Suppl 2):E171–E172
    32: Loske G, Schorsch T, Müller C (2011) Intraluminal and intracavitary vacuum therapy for esophageal leakage: a new endoscopic minimally invasive approach. Endoscopy 43:540–544
    33: Bludau M, Holscher AH, Herbold T et al (2013) Management of upper intestinal leaks using an endoscopic vacuum-assisted closure system (E-VAC). Surg Endosc 28:896–901
    34: Brangewitz M, Voigtlander T, Helfritz FA et al (2013) Endoscopic closure of esophageal intrathoracic leaks: stent versus endoscopic vacuum-assisted closure, a retrospective analysis. Endoscopy 45:433–438
    35: Kuehn F, Schiffmann L, Rau BM, Klar E (2012) Surgical endoscopic vacuum therapy for anastomotic leakage and perforation of the upper gastrointestinal tract. J Gastrointest Surg 16:2145–2150
    36: Weidenhagen R, Hartl WH, Gruetzner KU et al (2010) Anastomotic leakage after esophageal resection: new treatment options by endoluminal vacuum therapy. Ann Thorac Surg 90:1674–1681
    37: Schniewind B, Schafmayer C, Voehrs G et al (2013) Endoscopic endoluminal vacuum therapy is superior to other regimens in managing anastomotic leakage after esophagectomy: a comparative retrospective study. Surg Endosc 27:3883–3890
    38: Heits N, Stapel L, Reichert B et al (2014) Endoscopic endoluminal vacuum therapy in esophageal perforation. Ann Thorac Surg 97:1029–1035
    39: Schniewind B, Schafmayer C, Both M et al (2011) Ingrowth and device disintegration in an intralobar abscess cavity during endosponge therapy for esophageal anastomotic leakage. Endoscopy 43(Suppl 2 UCTN):E64–E65
    40: Schniewind B, Schafmayer C, Voehrs G et al (2013) Endoscopic endoluminal vacuum therapy is superior to other regimens in managing anastomotic leakage after esophagectomy: a comparative retrospective study. Surg Endosc 27:3883–3890

  4. Reviews

    Aiolfi A, Bonitta G, Campanelli G, Bona D; OGSA Group for Esophagogastric Surgery.. Impact of postoperative NSAIDs administration on anastomotic leak after esophago-gastric surgery: systematic review and meta-analysis. Updates Surg. 2023 Jun;75(4):817-824.

    Barbaro A, Eldredge TA, Shenfine J. Diagnosing anastomotic leak post-esophagectomy: a systematic review. Dis Esophagus. 2021 Feb 10;34(2).

    Casas MA, Angeramo CA, Bras Harriott C, Dreifuss NH, Schlottmann F. Indocyanine green (ICG) fluorescence imaging for prevention of anastomotic leak in totally minimally invasive Ivor Lewis esophagectomy: a systematic review and meta-analysis. Dis Esophagus. 2022 Apr 19;35(4).

    Grigor EJM, Kaaki S, Fergusson DA, Maziak DE, Seely AJE. Interventions to prevent anastomotic leak after esophageal surgery: a systematic review and meta-analysis. BMC Surg. 2021 Jan 18;21(1):42.

    Gu HY, Luo J, Qiang Y. Postoperative complications analysis of circular stapled versus linear stapled anastomosis for patients undergoing esophagectomy: a systematic review and meta-analysis. J Cardiothorac Surg. 2023 Aug 9;18(1):242.

    Gujjuri RR, Kamarajah SK, Markar SR. Effect of anastomotic leaks on long-term survival after oesophagectomy for oesophageal cancer: systematic review and meta-analysis. Dis Esophagus. 2021 Mar 8;34(3).

    Hua F, Sun D, Zhao X, Song X, Yang W. Update on therapeutic strategy for esophageal anastomotic leak: A systematic literature review. Thorac Cancer. 2023  Feb;14(4):339-347.

    Koyanagi K, Ozawa S, Ninomiya Y, Yatabe K, Higuchi T, Yamamoto M, Kanamori K, Tajima K. Indocyanine green fluorescence imaging for evaluating blood flow in the reconstructed conduit after esophageal cancer surgery. Surg Today. 2022 Mar;52(3):369-376.

    Li X, Yan S, Ma Y, Li S, Wang Y, Wang X, Wang Y, Wang J, Lv C, Yang Y, Wu N. Impact of Early Oral Feeding on Anastomotic Leakage Rate After Esophagectomy: A Systematic Review and Meta-analysis. World J Surg. 2020 Aug;44(8):2709-2718.

    Mandarino FV, Barchi A, D'Amico F, Fanti L, Azzolini F, Viale E, Esposito D, Rosati R, Fiorino G, Bemelman WA, Elmore U, Barbieri L, Puccetti F, Testoni SGG,  Danese S. Endoscopic Vacuum Therapy (EVT) versus Self-Expandable Metal Stent (SEMS) for Anastomotic Leaks after Upper Gastrointestinal Surgery: Systematic Review and Meta-Analysis. Life (Basel). 2023 Jan 19;13(2).

    Scognamiglio P, Reeh M, Melling N, Kantowski M, Eichelmann AK, Chon SH, El-Sourani N, Schön G, Höller A, Izbicki JR, Tachezy M. Management of intra-thoracic anastomotic leakages after esophagectomy: updated systematic review and meta-analysis of endoscopic vacuum therapy versus stenting. BMC Surg. 2022 Aug 11;22(1):309.

    Tavares G, Tustumi F, Tristão LS, Bernardo WM. Endoscopic vacuum therapy for anastomotic leak in esophagectomy and total gastrectomy: a systematic review and meta-analysis. Dis Esophagus. 2021 May 22;34(5). Erratum in: Dis Esophagus. 2021 May 22;34(5)

    van Kooten RT, Voeten DM, Steyerberg EW, Hartgrink HH, van Berge Henegouwen MI, van Hillegersberg R, Tollenaar RAEM, Wouters MWJM. Patient-Related Prognostic Factors for Anastomotic Leakage, Major Complications, and Short-Term Mortality Following Esophagectomy for Cancer: A Systematic Review and Meta-Analyses. Ann Surg Oncol. 2022 Feb;29(2):1358-1373.

  5. Guidelines

  6. literature search

    Literature search on the pages of pubmed.