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Endoluminal GERD treatments: critical appraisal of current literature with evidence-based medicine instruments

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Abstract

Background

The literature of endoluminal treatment of gastroesophageal reflux disease (GERD) widely varies in the level of evidence presented for analysis. Therefore there is a need for a comprehensive evidence-based medicine (EBM) analysis of the current literature evidence of the three FDA-approved modalities used for endoluminal treatment of GERD.

Search strategy

In January 2007, the MEDLINE database was searched for randomized controlled trials (RCTs), and controlled clinical trials of currently available endoluminal treatment of GERD. Database searches combined the specific endoluminal device keywords with the condition-specific keyword (e.g., GERD).

Data collection and analysis

All relevant studies have been categorized according to the evidence they provide according to the guidelines for Levels of Evidence and Grades of Recommendation supplied by the Oxford Centre for Evidence-Based Medicine.

Main results and Authors’ Conclusion

Sixteen studies met the inclusion criteria, representing 787 patients. The methodological quality of most of the included studies was average; four studies were grade 1b (individual randomized trial), 10 were grade 2b (individual cohort study), and two were grade 3b (individual case-control study)

There is grade 1b and 2b evidence demonstrating the EndoCinch plication is effective in reducing GERD symptoms at short-term follow up. However, in the majority of the studies analyzed, the procedure does not significantly reduce the acid exposure in the distal esophagus. The majority of the studies with long-term outcome showed disappointing outcomes, probably due to suture loss in the majority of patients.

There is grade 1b and 2b evidence demonstrating that the Stretta procedure is effective in reducing GERD symptoms at short- and mid-term follow up. However, in the majority of the studies analyzed, the procedure did not reduce significantly the acid exposure in the distal esophagus.

There is grade 1b and 2b evidence demonstrating that full-thickness plication is effective in reducing GERD symptoms, and acid exposure in the distal esophagus.

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References

  1. Donahue PE, Carvalho P, Yoshida J, Miidla I, Shen YJ, Bombeck CT, Nyhus LM (1989) Endoscopic sclerosis of the cardia affects gastroesophageal reflux. Surg Endosc 3: 11–2

    Article  PubMed  CAS  Google Scholar 

  2. Pearl JP, Marks JM (2007) Endolumenal therapies for gastroesophageal reflux disease: are they dead? Surg Endosc 21: 1–4

    Article  PubMed  Google Scholar 

  3. Tintillier M, Chaput A, Kirch L, Martinet JP, Pochet JM, Cuvelier C (2004) Esophageal abscess complicating endoscopic treatment of refractory gastroesophageal reflux disease by Enteryx injection: a first case report. Am J Gastroenterol 99: 1856–1858

    Article  PubMed  Google Scholar 

  4. Wong RF, Davis TV, Peterson KA (2005) Complications involving the mediastinum after injection of Enteryx for GERD. Gastrointest Endosc 61: 753–756

    Article  PubMed  Google Scholar 

  5. Fockens P, Bruno MJ, Gabbrielli A, Odegaard S, Hatlebakk J, Allescher HD, Rosch T, Rhodes M, Bastid C, Rey J, Boyer J, Muehldorffer S, van den Hombergh U, Costamagna G (2004) Endoscopic augmentation of the lower esophageal sphincter for the treatment of gastroesophageal reflux disease: multicenter study of the Gatekeeper Reflux Repair System. Endoscopy 36: 682–689

    Article  PubMed  CAS  Google Scholar 

  6. Swain P, Park PO, Mills T (2003) Bard EndoCinch: the device, the technique, and pre-clinical studies. Gastrointest Endosc Clin N Am 13: 75–88

    Article  PubMed  Google Scholar 

  7. Lutfi RE, Torquati A, Richards WO (2004) The endoscopic radiofrequency approach to management of GERD. Curr Opin Otolaryngol Head Neck Surg 12: 191–196

    Article  PubMed  Google Scholar 

  8. Schwartz MP, Wellink H, Gooszen HG, Conchillo JM, Samsom M, Smout AJ (2007) Endoscopic gastroplication for the treatment of gastro-oesophageal reflux disease: a randomised, sham-controlled trial. Gut 56: 20–28

    Article  PubMed  CAS  Google Scholar 

  9. Montgomery M, Hakanson B, Ljungqvist O, Ahlman B, Thorell A (2006) Twelve months’ follow-up after treatment with the EndoCinch endoscopic technique for gastro-oesophageal reflux disease: a randomized, placebo-controlled study. Scand J Gastroenterol 41: 1382–1389

    Article  PubMed  Google Scholar 

  10. Schiefke I, Zabel-Langhennig A, Neumann S, Feisthammel J, Moessner J, Caca K (2005) Long term failure of endoscopic gastroplication (EndoCinch). Gut 54: 752–758

    Article  PubMed  CAS  Google Scholar 

  11. Mahmood Z, McMahon BP, Arfin Q, Byrne PJ, Reynolds JV, Murphy EM, Weir DG (2003) Endocinch therapy for gastro-oesophageal reflux disease: a one year prospective follow up. Gut 52: 34–39

    Article  PubMed  CAS  Google Scholar 

  12. Filipi CJ, Lehman GA, Rothstein RI, Raijman I, Stiegmann GV, Waring JP, Hunter JG, Gostout CJ, Edmundowicz SA, Dunne DP, Watson PA, Cornet DA (2001) Transoral, flexible endoscopic suturing for treatment of GERD: a multicenter trial. Gastrointest Endosc 53: 416–422

    Article  PubMed  CAS  Google Scholar 

  13. Rothstein RI, Filipi CJ (2003) Endoscopic suturing for gastroesophageal reflux disease: clinical outcome with the Bard EndoCinch. Gastrointest Endosc Clin N Am 13: 89–101

    Article  PubMed  Google Scholar 

  14. Tam WC, Schoeman MN, Zhang Q, Dent J, Rigda R, Utley D, Holloway RH (2003) Delivery of radiofrequency energy to the lower oesophageal sphincter and gastric cardia inhibits transient lower oesophageal sphincter relaxations and gastro-oesophageal reflux in patients with reflux disease. Gut 52: 479–485

    Article  PubMed  CAS  Google Scholar 

  15. DiBaise JK, Brand RE, Quigley EM (2002) Endoluminal delivery of radiofrequency energy to the gastroesophageal junction in uncomplicated GERD: efficacy and potential mechanism of action. Am J Gastroenterol 97: 833–842

    Article  PubMed  Google Scholar 

  16. Corley DA, Katz P, Wo JM, Stefan A, Patti M, Rothstein R, Edmundowicz S, Kline M, Mason R, Wolfe MM (2003) Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial. Gastroenterology 125: 668–676

    Article  PubMed  Google Scholar 

  17. Triadafilopoulos G, DiBaise JK, Nostrant TT, Stollman NH, Anderson PK, Wolfe MM, Rothstein RI, Wo JM, Corley DA, Patti MG, Antignano LV, Goff JS, Edmundowicz SA, Castell DO, Rabine JC, Kim MS, Utley DS (2002) The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the U.S. open label trial. Gastrointest Endosc 55: 149–156

    Article  PubMed  Google Scholar 

  18. Richards WO, Houston HL, Torquati A, Khaitan L, Holzman MD, Sharp KW (2003) Paradigm shift in the management of gastroesophageal reflux disease. Ann Surg 237: 638–647; discussion 648–9

    Article  PubMed  Google Scholar 

  19. Cipolletta L, Rotondano G, Dughera L, Repici A, Bianco MA, De Angelis C, Vingiani AM, Battaglia E (2005) Delivery of radiofrequency energy to the gastroesophageal junction (Stretta procedure) for the treatment of gastroesophageal reflux disease. Surg Endosc 19: 849–853

    Article  PubMed  CAS  Google Scholar 

  20. Torquati A, Houston HL, Kaiser J, Holzman MD, Richards WO (2004) Long-term follow-up study of the Stretta procedure for the treatment of gastroesophageal reflux disease. Surg Endosc 18: 1475–1479

    Article  PubMed  CAS  Google Scholar 

  21. Chuttani R, Sud R, Sachdev G, Puri R, Kozarek R, Haber G, Pleskow D, Zaman M, Lembo A (2003) A novel endoscopic full-thickness plicator for the treatment of GERD: A pilot study. Gastrointest Endosc 58: 770–776

    Article  PubMed  Google Scholar 

  22. Pleskow D, Rothstein R, Lo S, Hawes R, Kozarek R, Haber G, Gostout C, Lembo A (2004) Endoscopic full-thickness plication for the treatment of GERD: a multicenter trial. Gastrointest Endosc 59: 163–171

    Article  PubMed  Google Scholar 

  23. Rothstein R, Filipi C, Caca K, Pruitt R, Mergener K, Torquati A, Haber G, Chen Y, Chang K, Wong D, Deviere J, Pleskow D, Lightdale C, Ades A, Kozarek R, Richards W, Lembo A (2006) Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: A randomized, sham-controlled trial. Gastroenterology 131: 704–712

    Article  PubMed  Google Scholar 

  24. Deviere J, Costamagna G, Neuhaus H, Voderholzer W, Louis H, Tringali A, Marchese M, Fiedler T, Darb-Esfahani P, Schumacher B (2005) Nonresorbable copolymer implantation for gastroesophageal reflux disease: a randomized sham-controlled multicenter trial. Gastroenterology 128: 532–540

    Article  PubMed  Google Scholar 

  25. Inadomi JM, Jamal R, Murata GH, Hoffman RM, Lavezo LA, Vigil JM, Swanson KM, Sonnenberg A (2001) Step-down management of gastroesophageal reflux disease. Gastroenterology 121: 1095–1100

    Article  PubMed  CAS  Google Scholar 

  26. Pleskow D, Rothstein R, Lo S, Hawes R, Kozarek R, Haber G, Gostout C, Lembo A (2005) Endoscopic full-thickness plication for the treatment of GERD: 12-month follow-up for the North American open-label trial. Gastrointest Endosc 61: 643–649

    Article  PubMed  Google Scholar 

  27. Bammer T, Hinder RA, Klaus A, Klingler PJ (2001) Five- to eight-year outcome of the first laparoscopic Nissen fundoplications. J Gastrointest Surg 5: 42–48

    Article  PubMed  CAS  Google Scholar 

  28. Pleskow D, Rothstein, R, Kozarek, R, Haber, G, Gostout, C, Lembo, A (2006) Endoscopic full-thickness plication for the treatment of GERD: long-term multicenter results. Surg Endosc Dec 16; [epub ahead of print]

  29. Arts J, Lerut T, Rutgeerts P, Sifrim D, Janssens J, Tack J (2005) A one-year follow-up study of endoluminal gastroplication (Endocinch) in GERD patients refractory to proton pump inhibitor therapy. Dig Dis Sci 50: 351–356

    Article  PubMed  CAS  Google Scholar 

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Correspondence to William O. Richards.

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Torquati, A., Richards, W.O. Endoluminal GERD treatments: critical appraisal of current literature with evidence-based medicine instruments. Surg Endosc 21, 697–706 (2007). https://doi.org/10.1007/s00464-007-9344-3

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  • DOI: https://doi.org/10.1007/s00464-007-9344-3

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