Skip to main content

Advertisement

SpringerLink
Log in

The Plicator procedure for the treatment of gastroesophageal reflux disease: a registry study

  • Endoluminal
  • Published:
Surgical Endoscopy Aims and scope Submit manuscript

Abstract

Background

Endoscopic full-thickness plication of the gastric cardia using the Plicator is shown to be effective for the treatment of symptomatic gastroesophageal reflux disease (GERD) in both prospective and randomized controlled trials. This registry study aimed to evaluate Plicator procedure safety and efficacy among GERD patients treated in routine clinical practice at multiple academic and nonacademic centers.

Methods

An open-label, prospective multicenter trial was conducted at seven centers under institutional review board approval. Patients with symptomatic GERD completed a series of questionnaires at baseline to assess GERD symptoms, heartburn/regurgitation scores, antisecretory medication use, and treatment satisfaction. All the patients then underwent the Plicator procedure with placement of a single transmural pledgeted suture in the anterior gastric cardia. The patients were reevaluated at 12 months after plication.

Results

The 12-month follow-up assessment was completed by 81 patients. At 12 months, the mean GERD Health-Related Quality-of-Life score had improved significantly compared with the baseline score (12.0 vs 26.6; p < 0.001), with 66% of the subjects showing an GERD-HRQL score improved 50% or more. Statistically significant improvements also were observed in median heartburn and regurgitation symptom scores. At 12 months, the need for daily proton pump inhibitor (PPI) therapy was eliminated for 58% of the patients. At baseline, 18% of the subjects had been satisfied with their GERD symptom control while on antisecretory therapy. At 12 months, 75% of the patients were satisfied with their GERD symptom control after undergoing the Plicator procedure, and 86% would recommend the procedure to family or friends. There were no serious adverse events and no late onset of any adverse events.

Conclusions

In this multicenter study, the Plicator procedure effectively improved GERD quality-of-life scores, reduced GERD symptoms and medication use, and yielded higher treatment satisfaction than with the use of chronic antisecretory therapy. These effects all were seen 12 months after plication, and no major adverse effects were observed.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5

Similar content being viewed by others

References

  1. Dean BB, Crawley JA, Schmitt CM, Wong J, Ofman JJ (2003) The burden of illness of gastro-oesophageal reflux disease: impact on work productivity. Aliment Pharmacol Ther 17:1309–1317

    Article  PubMed  CAS  Google Scholar 

  2. Frank L, Kleinman L, Ganoczy D, McQuaid K, Sloan S, Eggleston A, Tougas G, Farup C (2000) Upper gastrointestinal symptoms in North America: prevalence and relationship to healthcare utilization and quality of life. Dig Dis Sci 45:809–818

    Article  PubMed  CAS  Google Scholar 

  3. Sandler RS, Everhart JE, Donowitz M, Adams E, Cronin K, Goodman C, Gemmen E, Shah S, Avdic A, Rubin R (2002) The burden of selected digestive diseases in the United States. Gastroenterology 122:1500–1511

    Article  PubMed  Google Scholar 

  4. Fass R, Ofman JJ (2002) Gastroesophageal reflux disease: should we adopt a new conceptual framework? Am J Gastroenterol 97:1901–1909

    PubMed  Google Scholar 

  5. Poelmans J, Tack J (2005) Extraoesophageal manifestations of gastro-oesophageal reflux. Gut 54:1492–1499

    Article  PubMed  CAS  Google Scholar 

  6. Ruigomez A, Garcia Rodriguez LA, Wallander MA, Johansson S, Graffner H, Dent J (2004) Natural history of gastro-oesophageal reflux disease diagnosed in general practice. Aliment Pharmacol Ther 20:751–760

    Article  PubMed  CAS  Google Scholar 

  7. Wiklund I (2004) Review of the quality of life and burden of illness in gastroesophageal reflux disease. Dig Dis 22:108–114

    Article  PubMed  Google Scholar 

  8. Dent J, El-Serag HB, Wallander MA, Johansson S (2005) Epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut 54:710–717

    Article  PubMed  CAS  Google Scholar 

  9. Lagergren J, Bergstrom R, Lindgren A, Nyren O (1999) Symptomatic gastroesophageal reflux as a risk factor for esophageal adenocarcinoma. New Engl J Med 340:825–831

    Article  PubMed  CAS  Google Scholar 

  10. Joish VN, Donaldson G, Stockdale W, Ordera GM, Crawley J, Sasane R, Joshua-Gotlib S, Brixner DI (2005) The economic impact of GERD and PUD: examination of direct and indirect costs using a large integrated employer claims database. Curr Med Res Opin 21:535–544

    Article  PubMed  Google Scholar 

  11. Lauritsen K, Deviere J, Bigard MA, Bayerdorffer E, Mozsik G, Murray F, Kristjansdottir S, Savarino V, Vetvik K, DeFreitas D, Orive V, Rodrigo L, Fried M, Morris J, Schneider H, Eklund S, Larko A (2003) Esopmeprazole 20 mg and lansoprazole 15 mg in maintaining healed reflux oesophagitis: metropole study results. Ailment Pharmacol Ther 17:333–341

    Article  CAS  Google Scholar 

  12. Klinkenberg-Knol EC, Nelis F, Dent J, Snel P, Mitchell B, Prichard P, Lloyd D, Havu N, Frame MH, Roman J, Walan A (2000) Long-term omeprazole treatment in resistant gastroesophageal reflux disease: efficacy, safety, and influence on gastric mucosa. Gastroenterology 118:661–669

    Article  PubMed  CAS  Google Scholar 

  13. Leite LP, Johnston BT, Just RJ, Castell DO (1996) Persistent acid secretion during omeprazole therapy: a study of gastric acid profiles in patients demonstrating failure of omeprazole therapy. Am J Gastroenterol 91:1527–1531

    PubMed  CAS  Google Scholar 

  14. Chiba N, De Gara CJ, Wilkinson JM, Hunt RH (1997) Speed of healing and symptom relief in grade II to IV gastroesophageal reflux disease: a meta-analysis. Gastroenterology 112:1798–1810

    Article  PubMed  CAS  Google Scholar 

  15. Lafullarde T, Watson DI, Jamieson GG, Myers JC, Game PA, Devitt PG (2001) Laparoscopic Nissen fundoplications: five-year results and beyond. Arch Surg 136:180–184

    Article  PubMed  CAS  Google Scholar 

  16. Gotley DC, Smithers BM, Rhodes M, Menzies B, Branicki FJ, Nathanson L (1996) Laparoscopic Nissen fundoplication: 200 consecutive cases. Gut 38:487–491

    Article  PubMed  CAS  Google Scholar 

  17. Hunter JG, Trus TL, Branum GD, Waring JP, Wood WC (1996) A physiologic approach to laparoscopic fundoplication for gastroesophageal reflux disease. Ann Surg 223:673–685

    Article  PubMed  CAS  Google Scholar 

  18. Rantanen TK, Salo JA, Sipponen JT (1999) Fatal and life-threatening complications in antireflux surgery: analysis of 5,502 operations. Br J Surg 86:1573–1577

    Article  PubMed  CAS  Google Scholar 

  19. Swanstrom L, Wayne R (1994) Spectrum of gastrointestinal symptoms after laparoscopic fundoplication. Am J Surg 167:538–541

    Article  PubMed  CAS  Google Scholar 

  20. Spechler SJ, Lee E, Ahnen D, Goyal RK, Hirano I, Ramirez F, Raufman JP, Sampliner R, Schnell T, Sontag S, Vlahcevic ZR, Young R, Williford W (2001) Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease: follow-up of a randomized controlled trial. JAMA 285:2331–2338

    Article  PubMed  CAS  Google Scholar 

  21. Freston JW, Triadofilopoulos G (2004) Review article: approaches to the long-term management of adults with GERD-proton pump inhibitor therapy, laparoscopic fundoplication, or endoscopic therapy? Aliment Pharmacol Ther 19(Suppl 1):35–42

    Article  PubMed  Google Scholar 

  22. 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 

  23. Schwartz MP, Wellink H, Gooszen HG, Conchillo JM, Samsom M, Smout A (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 

  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. Cadiere GB, Rajan A, Germay O, Jimpens J (2007) Endoluminal fundoplication by a transoral device for the treatment of GERD: a feasibility study. Surg Endosc 10.1007/s00464-007-9618-9

  26. 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 

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

    Article  PubMed  Google Scholar 

  28. 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 

  29. 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 21:439–444

    Article  PubMed  Google Scholar 

  30. Pleskow D, Rothstein R, Kozarek R, Haber G, Gostout C, Lo S, Hawes R, Lembo A (2007) Endoscopic full-thickness plication for the treatment of GERD: five-year long-term multicenter results. Surg Endosc 10.1007/s00464-007-9667-0

  31. Pleskow D, Rothstein R, Kozarek R, Haber G, Gostout C, Lo S, Hawes R, Lembo A (2008) Endoscopic full-thickness plication for the treatment of GERD: five-year long-term multicenter results. Surg Endosc 22:326–332; Epub 2007 November

    Article  PubMed  Google Scholar 

  32. Velanovich V, Vallance SR, Gusz JR, Tapia FV, Harkabus MA (1996) Quality-of-life scale for gastroesophageal reflux disease. J Am Coll Surg 183:217–224

    PubMed  CAS  Google Scholar 

  33. Spechler SJ, Lee E, Ahnen D, Goyal RK, Hirano I, Ramirez F, Raufman JP, Sampliner R, Schnell T, Sontag S, Vlahcevic R, Young R, Williford W (2001) Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease: follow-up of a randomized controlled trial. JAMA 285:2331–2338

    Article  PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Stony Brook University Medical Center, Stony Brook, NY, USA

    John Birk

  2. Department of Gastroenterology, University of Connecticut Health Center, 263 Farmington Avenue, Farmington, CT, 06030-1845, USA

    John Birk

  3. Nashville Medical Research and the Maria Nathanson Center of Excellence, Nashville, TN, USA

    Ronald Pruitt

  4. Lenox Hill Hospital, New York, NY, USA

    Gregory Haber

  5. Digestive Associates of Houston, Houston, TX, USA

    Isaac Raijman

  6. Northside Gastroenterology, Indianapolis, IN, USA

    Arthur Baluyut

  7. Evanston Northwestern Healthcare, Evanston, IL, USA

    Mick Meiselman

  8. Gastroenterology Associates of Central Georgia, Macon, GA, USA

    Shahriar Sedghi

Authors
  1. John Birk
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Ronald Pruitt
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Gregory Haber
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Isaac Raijman
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Arthur Baluyut
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Mick Meiselman
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Shahriar Sedghi
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to John Birk.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Birk, J., Pruitt, R., Haber, G. et al. The Plicator procedure for the treatment of gastroesophageal reflux disease: a registry study. Surg Endosc 23, 423–431 (2009). https://doi.org/10.1007/s00464-008-0109-4

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00464-008-0109-4

Keywords

Search

Navigation