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Journal of Gastroenterology

, Volume 44, Issue 7, pp 675–684 | Cite as

Short-term and long-term outcome of endoluminal gastroplication for the treatment of GERD: the first multicenter trial in Japan

  • Soji OzawaEmail author
  • Koichiro Kumai
  • Kazuhide Higuchi
  • Tetsuo Arakawa
  • Mototsugu Kato
  • Masahiro Asaka
  • Natsuya Katada
  • Hiroyuki Kuwano
  • Masaki Kitajima
Original Article—Alimentary Tract

Abstract

Purpose

Endoluminal gastroplication (ELGP) was the first endoscopic therapy for gastroesophageal reflux disease (GERD). Data on the long-term outcomes, including the plication status and data from Asian populations, are limited. The aim of this study was to evaluate the short-term and long-term effectiveness and safety of ELGP for GERD in the Japanese population.

Methods

This was an open-label, prospective, multicenter trial of ELGP. Forty-eight patients with GERD were enrolled. The procedure involved placing circumferential plications 1–2 cm below the GE junction using the EndoCinch system. Outcome measurements were improvement of heartburn, medication use, endoscopic Los Angeles grade, durability of plications, 24-h esophageal acid exposure, esophageal manometry, and frequency of adverse events.

Results

During the 24-month follow-up, the rate of complete resolution of heartburn ranged from 54 to 66%, the rate of discontinuation or reduction of PPI/H2RA use ranged from 65 to 76%, and the rate of endoscopic classification to grade O ranged from 66 to 81%. The status with more than one plication remaining was associated with higher rates of improvement of heartburn, PPI/H2RA use, and endoscopic findings as compared with those associated with the loss of all plications. A modest decrease of the esophageal acid exposure level, but no change of the manometric parameters, was observed after ELGP. No serious adverse events were observed.

Conclusions

In this 24-month follow-up study conducted in Japanese subjects, ELGP was found to be effective in about 60% of patients with GERD, and the procedure was safe.

Keywords

GERD ELGP 

Notes

Acknowledgments

The authors thank Professor Shuji Hashimoto, Department of Hygiene, School of Medicine, Fujita Health University, for his invaluable help with the statistical analysis.

References

  1. 1.
    Dent J, El-Serag HB, Wallander MA, Johansson S. Epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2005;54:710–7.PubMedCrossRefGoogle Scholar
  2. 2.
    Kang JY. Systematic review: geographical and ethnic differences in gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2004;20:705–17.PubMedCrossRefGoogle Scholar
  3. 3.
    Wong BC, Kinoshita Y. Systematic review on epidemiology of gastroesophageal reflux disease in Asia. Clin Gastroenterol Hepatol. 2006;4:398–407.PubMedCrossRefGoogle Scholar
  4. 4.
    Fujiwara Y, Higuchi K, Watanabe Y, Shiba M, Watanabe T, Tominaga K, et al. Prevalence of gastroesophageal reflux disease and gastroesophageal reflux disease symptoms in Japan. J Gastroenterol Hepatol. 2005;20:26–9.PubMedCrossRefGoogle Scholar
  5. 5.
    Fujimoto K. Review article: prevalence and epidemiology of gastro-oesophageal reflux disease in Japan. Aliment Pharmacol Ther. 2004;20(Suppl 8):5–8.PubMedCrossRefGoogle Scholar
  6. 6.
    Swain CP, Mills TN. An endoscopic sewing machine. Gastrointest Endosc. 1986;32:36–8.PubMedCrossRefGoogle Scholar
  7. 7.
    Kadirkamanathan SS, Evans DF, Gong F, Yazaki E, Scott M, Swain CP. Antireflux operations at flexible endoscopy using endoluminal stitching techniques: an experimental study. Gastrointest Endosc. 1996;44:133–43.PubMedCrossRefGoogle Scholar
  8. 8.
    Filipi CJ, Lehman GA, Rothstein RI, Raijman I, Stiegmann GV, Waring JP, et al. Transoral, flexible endoscopic suturing for treatment of GERD: a multicenter trial. Gastrointest Endosc. 2001;53:416–22.PubMedCrossRefGoogle Scholar
  9. 9.
    Mahmood Z, McMahon BP, Arfin Q, Byrne PJ, Reynolds JV, Murphy EM, et al. Endocinch therapy for gastro-oesophageal reflux disease: a one year prospective follow up. Gut. 2003;52:34–9.PubMedCrossRefGoogle Scholar
  10. 10.
    Chen YK, Raijman I, Ben-Menachem T, Starpoli AA, Liu J, Pazwash H, et al. Long-term outcomes of endoluminal gastroplication: a U.S. multicenter trial. Gastrointest Endosc. 2005;61:659–67.PubMedCrossRefGoogle Scholar
  11. 11.
    Schiefke I, Zabel-Langhennig A, Neumann S, Feisthammel J, Moessner J, Caca K. Long term failure of endoscopic gastroplication (EndoCinch). Gut. 2005;54:752–8.PubMedCrossRefGoogle Scholar
  12. 12.
    Liao CC, Lee CL, Lin BR, Bai CH, Hsieh YH, Wu CH, et al. Endoluminal gastroplication for the treatment of gastroesophageal reflux disease: a 2-year prospective pilot study from Taiwan. J Gastroenterol Hepatol. 2008;23:398–405.PubMedCrossRefGoogle Scholar
  13. 13.
    Carlsson R, Dent J, Bolling-Sternevald E, Johnsson F, Junghard O, Lauritsen K, et al. The usefulness of a structured questionnaire in the assessment of symptomatic gastroesophageal reflux disease. Scand J Gastroenterol. 1998;33:1023–9.PubMedCrossRefGoogle Scholar
  14. 14.
    Armstrong D, Bennett JR, Blum AL, Dent J, De Dombal FT, Galmiche JP, et al. The endoscopic assessment of esophagitis: a progress report on observer agreement. Gastroenterology. 1996;111:85–92.PubMedCrossRefGoogle Scholar
  15. 15.
    Schwartz MP, Wellink H, Gooszen HG, Conchillo JM, Samsom M, Smout AJ. Endoscopic gastroplication for the treatment of gastro-oesophageal reflux disease: a randomised, sham-controlled trial. Gut. 2007;56:20–8.PubMedCrossRefGoogle Scholar
  16. 16.
    Abou-Rebyeh H, Hoepffner N, Rösch T, Osmanoglou E, Haneke JH, Hintze RE, et al. Long-term failure of endoscopic suturing in the treatment of gastroesophageal reflux: a prospective follow-up study. Endoscopy. 2005;37:213–6.PubMedCrossRefGoogle Scholar
  17. 17.
    Montgomery M, Håkanson B, Ljungqvist O, Ahlman B, Thorell A. Twelve months’ follow-up after treatment with the EndoCinch endoscopic technique for gastro-oesophageal reflux disease: a randomized, placebo-controlled study. Scand J Gastroenterol. 2006;41:1382–9.PubMedCrossRefGoogle Scholar
  18. 18.
    Higuchi K, Shiba M, Okazaki H, Tabuchi M, Kameda N, Kadouchi K, et al. Four-year follow-up of the first case of gastroesophageal reflux disease treated with endoluminal gastroplication in Japan. J Gastroenterol. 2007;42:325–6.PubMedCrossRefGoogle Scholar
  19. 19.
    Kleemann M, Langner C, Müldner A, Weiss C, Manegold BC. Depth of endoscopically placed sutures: an experimental study in a human cadaver model. Surg Endosc. 2005;19:1602–5.PubMedCrossRefGoogle Scholar
  20. 20.
    Tam WC, Holloway RH, Dent J, Rigda R, Schoeman MN. Impact of endoscopic suturing of the gastroesophageal junction on lower esophageal sphincter function and gastroesophageal reflux in patients with reflux disease. Am J Gastroenterol. 2004;99:195–202.PubMedCrossRefGoogle Scholar
  21. 21.
    Liu JJ, Glickman JN, Carr-Locke DL, Brooks DC, Saltzman JR. Gastroesophageal junction smooth muscle remodeling after endoluminal gastroplication. Am J Gastroenterol. 2004;99:1895–901.PubMedCrossRefGoogle Scholar
  22. 22.
    Wenzel G, Kuhlbusch R, Heise J, Frieling T. Relief of reflux symptoms after endoscopic gastroplication may be associated with reduced esophageal acid sensitivity: a pilot study. Endoscopy. 2005;37:236–9.PubMedCrossRefGoogle Scholar
  23. 23.
    Hill LD, Kozarek RA, Kraemer SJ, Aye RW, Mercer CD, Low DE, et al. The gastroesophageal flap valve: in vitro and in vivo observations. Gastrointest Endosc. 1996;44:541–7.PubMedCrossRefGoogle Scholar
  24. 24.
    Liu JJ, Glickman JN, Li X, Maurer R, Ashley SW, Brooks DC, et al. Smooth muscle remodeling of the gastroesophageal junction after endoluminal gastroplication. Gastrointest Endosc. 2007;65:1023–7.PubMedCrossRefGoogle Scholar
  25. 25.
    Arts J, Lerut T, Rutgeerts P, Sifrim D, Janssens J, Tack J. A one-year follow-up study of endoluminal gastroplication (Endocinch) in GERD patients refractory to proton pump inhibitor therapy. Dig Dis Sci. 2005;50:351–6.PubMedCrossRefGoogle Scholar
  26. 26.
    Ozawa S, Yoshida M, Kumai K, Kitajima M. New endoscopic treatments for gastroesophageal reflux disease. Ann Thorac Cardiovasc Surg. 2005;11:146–53.PubMedGoogle Scholar
  27. 27.
    Pleskow D, Rothstein R, Lo S, Hawes R, Kozarek R, Haber G, et al. Endoscopic full-thickness plication for the treatment of GERD: 12-month follow-up for the North American open-label trial. Gastrointest Endosc. 2005;61:643–9.PubMedCrossRefGoogle Scholar
  28. 28.
    Pleskow D, Rothstein R, Kozarek R, Haber G, Gostout C, Lembo A. Endoscopic full-thickness plication for the treatment of GERD: long-term multicenter results. Surg Endosc. 2007;21:439–44.PubMedCrossRefGoogle Scholar
  29. 29.
    Pleskow D, Rothstein R, Kozarek R, Haber G, Gostout C, Lo S, et al. Endoscopic full-thickness plication for the treatment of GERD: five-year long-term multicenter results. Surg Endosc. 2008;22:326–32.PubMedCrossRefGoogle Scholar
  30. 30.
    Triadafilopoulos G, DiBaise JK, Nostrant TT, Stollman NH, Anderson PK, Wolfe MM, et al. The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the U.S. open label trial. Gastrointest Endosc. 2002;55:149–56.PubMedCrossRefGoogle Scholar
  31. 31.
    Noar MD, Lotfi-Emran S. Sustained improvement in symptoms of GERD and antisecretory drug use: 4-year follow-up of the Stretta procedure. Gastrointest Endosc. 2007;65:367–72.PubMedCrossRefGoogle Scholar
  32. 32.
    Higuchi K, Fujiwara Y, Okazaki H, Tabuchi M, Kameda N, Kadouchi K, et al. Feasibility, safety, and efficacy of the Stretta procedure in Japanese patients with gastroesophageal reflux disease: first report from Asia. J Gastroenterol. 2007;42:205–10.PubMedCrossRefGoogle Scholar
  33. 33.
    Fujimoto K, Iwakiri R, Okamoto K, Oda K, Tanaka A, Tsunada S, et al. Characteristics of gastroesophageal reflux disease in Japan: increased prevalence in elderly women. J Gastroenterol. 2003;38(Suppl 15):3–6.PubMedGoogle Scholar

Copyright information

© Springer 2009

Authors and Affiliations

  • Soji Ozawa
    • 1
    Email author
  • Koichiro Kumai
    • 2
  • Kazuhide Higuchi
    • 3
  • Tetsuo Arakawa
    • 4
  • Mototsugu Kato
    • 5
  • Masahiro Asaka
    • 6
  • Natsuya Katada
    • 7
  • Hiroyuki Kuwano
    • 8
  • Masaki Kitajima
    • 9
  1. 1.Department of General and Gastrointestinal Surgery, School of MedicineFujita Health UniversityNagoyaJapan
  2. 2.Department of SurgeryHino Municipal HospitalHinoJapan
  3. 3.2nd Department of Internal MedicineOsaka Medical CollegeTakatsukiJapan
  4. 4.Department of GastroenterologyOsaka City University Graduate School of MedicineOsakaJapan
  5. 5.Division of EndoscopyHokkaido University HospitalSapporoJapan
  6. 6.Department of Gastroenterology and HematologyHokkaido University Graduate School of MedicineSapporoJapan
  7. 7.Department of Surgery, School of MedicineKitasato UniversitySagamiharaJapan
  8. 8.Department of General Surgical ScienceGunma University Graduate School of MedicineMaebashiJapan
  9. 9.Department of SurgeryInternational University of Health and Welfare Mita HospitalTokyoJapan

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