Systematic review: Endoluminal therapy for gastro-oesophageal reflux disease: Evidence from clinical trials

European Journal of Gastroenterology and Hepatology

Volumn 19, Issue 12, 2007, Pages 1125-1139

  Fry, Lucía C ^a   Mönkemüller, Klaus ^a,b   Malfertheiner, Peter ^a  

^a OTTO VON GUERICKE UNIVERSITY   (Germany)

^b UNIVERSITY HOSPITAL MAGDEBURG   (Germany)

Author keywords

EndoCinch; Endoscopic sewing devices; Endotherapy; Enteryx; Gastro oesophageal reflux disease; Gatekeeper; Oesophagitis; Plicator; Radiofrequency ablation

Indexed keywords

PROTON PUMP INHIBITOR;

ABSCESS; CASE STUDY; COCHRANE LIBRARY; DATA EXTRACTION; DATA SYNTHESIS; DEATH; ENDOSCOPIC THERAPY; FOLLOW UP; GASTROESOPHAGEAL REFLUX; HUMAN; MEDLINE; METHODOLOGY; OUTCOME ASSESSMENT; PERFORATION; POPULATION; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUALITY OF LIFE; RETROSPECTIVE STUDY; REVIEW; SAFETY; SAMPLE SIZE; SHAM FEEDING; SYSTEMATIC REVIEW;

ANTACIDS; CATHETER ABLATION; DRUG ADMINISTRATION SCHEDULE; ESOPHAGOSCOPY; EVIDENCE-BASED MEDICINE; GASTROESOPHAGEAL REFLUX; GASTROSCOPY; HUMANS; PROTON PUMPS; SUTURE TECHNIQUES; TREATMENT OUTCOME;

EID: 36248959823     PISSN: 0954691X     EISSN: None     Source Type: Journal    
DOI: 10.1097/MEG.0b013e3282f16a21     Document Type: Review

References (95)

1. Locke GR 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology 1997; 112:1448-1456.
2. Nebel OT, Fornes MF, Castell DO. Symptomatic gastroesophageal reflux: incidence and precipitating factors. Am J Dig Dis 1976; 21:953-956.
3. Kahrilas PJ. Gastroesophageal reflux disease. JAMA 1996; 276:983-988.
4. DeVault KR, Castell DO; American College of Gastroenterology. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J Gastroenterol 2005; 100:190-200.
5. Inadomi JM, Fendrick AM. PPI use in the OTC era: who to treat, with what, and for how long? Clin Gastroenterol Hepatol 2005; 3:208-215.
6. Malfertheiner P, Hallerback B. Clinical manifestations and complications of gastroesophageal reflux disease (GERD). Int J Clin Pract 2005; 59:346-355.
7. Malfertheiner P, Lind T, Willich S, Vieth M, Jaspersen D, Labenz J, et al. Prognostic influence of Barrett's oesophagus and Helicobacter pylori infection on healing of erosive gastro-oesophageal reflux disease (GORD) and symptom resolution in non-erosive GORD: report from the ProGORD study. Gut 2005; 54:746-751.
8. Jones R, Armstrong D, Malfertheiner P, Ducrotte P. Does the treatment of gastroesophageal reflux disease (GERD) meet patients' needs? A survey-based study. Curr Med Res Opin 2006; 22:657-662.
9. Fennerty MB. Review article: alternative approaches to the long-term management of GERD. Aliment Pharmacol Ther 2005; 22 (Suppl 3):39-44.
10. Kahrilas PJ. Management of GERD: medical versus surgical. Semin Gastrointest Dis 2001; 12:3-15.
11. Dallemagne B, Weerts J, Markiewicz S, Dewandre JM, Wahlen C, Monami B, Jehaes C. Clinical results of laparoscopic fundoplication at ten years after surgery. Surg Endosc 2006; 20:159-165.
12. Lundell L, Miettinen P, Myrvold HE, Pedersen SA, Liedman B, Hatlebakk JG, et al. Continued (5-year) followup of a randomized clinical study comparing antireflux surgery and omeprazole in gastroesophageal reflux disease. J Am Coll Surg 2001; 192:172-179.
13. Spechler SJ, Lee E, Ahnen D, Goyal RK, Hirano I, Ramirez F, et al. Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease: follow-up of a randomized controlled trial. JAMA 2001; 285:2331-2338.
14. Vakil N, Shaw M, Kirby R. Clinical effectiveness of laparoscopic fundoplication in a U.S. community. Am J Med 2003; 114:1-5.
15. Madan A, Minocha A. Despite high satisfaction, majority of gastrooesophageal reflux disease patients continue to use proton pump inhibitors after antireflux surgery. Aliment Pharmacol Ther 2006; 23:601-605.
16. Franzen T, Anderberg B, Wiren M, Johansson KE. Long-term outcome is worse after laparoscopic than after conventional Nissen fundoplication. Scand J Gastroenterol 2005; 40:1261-1268.
17. Zehetner J, Holzinger F, Breuhahn T, Geppert C, Klaiber C. Five-year results of laparoscopic Toupet fundoplication as the primary surgical repair in GERD patients: is it durable? Surg Endosc 2006; 20:220-225.
18. Carlson MA, Frantzides CT. Complications and results of primary minimally invasive antireflux procedures: a review of 10735 reported cases. J Am Coll Surg 2001; 193:428-439.
19. Flum DR, Koepsell T, Heagerty P, Pellegrini CA. The nationwide frequency of major adverse outcomes in antireflux surgery and the role of surgeon experience, 1992-1997. J Am Coll Surg 2002; 195:611-618.
20. Annese V, Caletti G, Cipolletta L, Costamagna G, D'Onofrio V, Leandro G, et al. Endoscopic treatment of gastroesophageal reflux disease. Endoscopy 2005; 37:470-478.
21. Iqbal A, Salinas V, Filipi CJ. Endoscopic therapies of gastroesophageal reflux disease. World J Gastroenterol 2006; 12:2641-2655.
22. Ozawa S, Yoshida M, Kumai K, Kitajima M. New endoscopic treatments for gastroesophageal reflux disease. Ann Thorac Cardiovasc Surg 2005; 11:146-153.
23. Utley DS, Kim M, Vierra MA, Triadafilopoulos G. Augmentation of lower esophageal sphincter pressure and gastric yield pressure after radiofrequency energy delivery to the gastroesophageal junction: a porcine model. Gastrointest Endosc 2000; 52:81-86.
24. Richards WO, Scholz S, Khaitan L, Sharp KW, Holzman MD. Initial experience with the Stretta procedure for the treatment of gastroesophageal reflux disease. J Laparoendosc Adv Surg Tech A 2001; 11:267-273.
25. Richards WO, Houston HL, Torquati A, Khaitan L, Holzman MD, Sharp KW. Paradigm shift in the management of gastroesophageal reflux disease. Ann Surg 2003; 237:638-647.
26. Kahrilas PJ. Radiofrequency therapy of the lower esophageal sphincter for treatment of GERD. Gastrointest Endosc 2003; 57:723-731.
27. Triadafilopoulos G, Dibaise JK, Nostrant TT, Stollman NH, Anderson PK, Edmundowicz SA, et al. Radiofrequency energy delivery to the gastroesophageal junction for the treatment of GERD. Gastrointest Endosc 2001; 53:407-415.
28. Triadafilopoulos G, Utley DS. Temperature-controlled radiofrequency energy delivery for gastroesophageal reflux disease: the Stretta procedure. J Laparoendosc Adv Surg Tech A 2001; 11:333-339.
29. 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; 55:149-156.
30. Wolfsen HC, Richards WO. The Stretta procedure for the treatment of GERD: a registry of 558 patients. J Laparoendosc Adv Surg Tech A 2002; 12:395-402.
31. DiBaise JK, Brand RE, Quigley EM. Endoluminal delivery of radiofrequency energy to the gastroesophageal junction in uncomplicated GERD: efficacy and potential mechanism of action. Am J Gastroenterol 2002; 97:833-842.
32. Tam WC, Schoeman MN, Zhang Q, Dent J, Rigda R, Utley D, Holloway RH. 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 2003; 52:479-485.
33. Houston H, Khaitan L, Holzman M, Richards WO. First year experience of patients undergoing the Stretta procedure. Surg Endosc 2003; 17:401-404.
34. Corley DA, Katz P, Wo JM, Stefan A, Patti M, Rothstein R, et al. Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial. Gastroenterology 2003; 125:668-676.
35. Torquati A, Houston HL, Kaiser J, Holzman MD, Richards WO. Long-term follow-up study of the Stretta procedure for the treatment of gastroesophageal reflux disease. Surg Endosc 2004; 18:1475-1479.
36. Go MR, Dundon JM, Karlowicz DJ, Domingo CB, Muscarella P, Melvin WS. Delivery of radiofrequency energy to the lower esophageal sphincter improves symptoms of gastroesophageal reflux. Surgery 2004; 136:786-794.
37. Triadafilopoulos G. Changes in GERD symptom scores correlate with improvement in esophageal acid exposure after the Stretta procedure. Surg Endosc 2004; 18:1038-1044.
38. Islam S, Geiger JD, Coran AG, Teitelbaum DH. Use of radiofrequency ablation of the lower esophageal sphincter to treat recurrent gastroesophageal reflux disease. J Pediatr Surg 2004; 39:282-286.
39. Cipolletta L, Rotondano G, Dughera L, Repici A, Bianco MA, De Angelis C, et al. Delivery of radiofrequency energy to the gastroesophageal junction (Stretta procedure) for the treatment of gastroesophageal reflux disease. Surg Endosc 2005; 19:849-853.
40. Lutfi RE, Torquati A, Kaiser J, Holzman M, Richards WO. Three years' experience with the Stretta procedure: did it really make a difference? Surg Endosc 2005; 19:289-295.
41. 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; 65:367-372.
42. Reymunde A, Santiago N. Long-term results of radiofrequency energy delivery for the treatment of GERD: sustained improvements in symptoms, quality of life, and drug use at 4-year follow-up. Gastrointest Endosc 2007; 65:361-366.
43. Arts J, Sifrim D, Rutgeerts P, Lerut A, Janssens J, Tack J. Influence of radiofrequency energy delivery at the gastroesophageal junction (the Stretta procedure) on symptoms, acid exposure, and esophageal sensitivity to acid perfusion in gastroesophageal reflux disease. Dig Dis Sci 2007; 52:2170-2177.
44. Peters JH, Silverman DE, Stein A. Lower esophageal sphincter injection of a biocompatible polymer: accuracy of implantation assessed by esophagectomy. Surg Endosc 2003; 17:547-550.
45. Deviere J, Pastorelli A, Louis H, de Maertelaer V, Lehman G, Cicala M, et al. Endoscopic implantation of a biopolymer in the lower esophageal sphincter for gastroesophageal reflux: a pilot study. Gastrointest Endosc 2002; 55:335-341.
46. Johnson DA, Ganz R, Aisenberg J, Cohen LB, Deviere J, Foley TR, et al. Endoscopic, deep mural implantation of Enteryx for the treatment of GERD: 6-month follow-up of a multicenter trial. Am J Gastroenterol 2003; 98:250-258.
47. Johnson DA, Ganz R, Aisenberg J, Cohen LB, Deviere J, Foley TR, et al. Endoscopic implantation of Enteryx for treatment of GERD: 12-month results of a prospective, multicenter trial. Am J Gastroenterol 2003; 98:1921-1930.
48. Cohen LB, Johnson DA, Ganz RA, Aisenberg J, Deviere J, Foley TR, et al. Enteryx implantation for GERD: expanded multicenter trial results and interim postapproval follow-up to 24 months. Gastrointest Endosc 2005; 61:650-658.
49. Deviere J, Costamagna G, Neuhaus H, Voderholzer W, Louis H, Tringali A, et al. Nonresorbable copolymer implantation for gastroesophageal reflux disease: a randomized sham-controlled multicenter trial. Gastroenterology 2005; 128:532-540.
50. Schumacher B, Neuhaus H, Ortner M, Laugier R, Benson M, Boyer J, et al. Reduced medication dependency and improved symptoms and quality of life 12 months after Enteryx implantation for gastroesophageal reflux. J Clin Gastroenterol 2005; 39:212-219.
51. Kahrilas PJ, Lee TJ. Gatekeeper reflux repair system; a mechanistic hypothesis. Gut 2005; 54:179-180.
52. Fockens P, Bruno MJ, Gabbrielli A, Odegaard S, Hatlebakk J, Allescher HD, et al. Endoscopic augmentation of the lower esophageal sphincter for the treatment of gastroesophageal reflux disease: multicenter study of the Gatekeeper reflux repair system. Endoscopy 2004; 36:682-689.
53. Feretis C, Benakis P, Dimopoulos C, Dailianas A, Filalithis P, Stamou KM, et al. Endoscopic implantation of Plexiglas (PMMA) microspheres for the treatment of GERD. Gastrointest Endosc 2001; 53:423-426.
54. 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; 53:416-422.
55. 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; 52:34-39.
56. Thomson M, Fritscher-Ravens A, Hall S, Afzal N, Ashwood P, Swain CP. Endoluminal gastroplication in children with significant gastro-oesophageal reflux disease. Gut 2004; 53:1745-1750.
57. Liu JJ, Carr-Locke DL, Lee LS, Brooks DC, Saltzman JR. Endoluminal gastroplication for treatment of patients with classic gastroesophageal reflux symptoms and borderline 24-h pH studies. Scand J Gastroenterol 2004; 39:615-620.
58. 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.
59. 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; 50:351-356.
60. 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; 37:213-216.
61. 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; 61:659-667.
62. Schiefke I, Soeder H, Zabel-Langhennig A, Teich N, Neumann S, Borte G, et al. Endoluminal gastroplication: what are the predictors of outcome? Scand J Gastroenterol 2004; 39:1296-1303.
63. Liu JJ, Carr-Locke DL, Osterman MT, Li X, Maurer R, Brooks DC, et al. Endoscopic treatment for atypical manifestations of gastroesophageal reflux disease. Am J Gastroenterol 2006; 101:440-445.
64. Liu JJ, Di Sena V, Ookubo R, Carr-Locke DL, Saltzman JR. Endoscopic treatment of gastroesophageal reflux disease: effect of gender on clinical outcome. Scand J Gastroenterol 2006; 41:144-148.
65. Schiefke I, Zabel-Langhennig A, Neumann S, Feisthammel J, Moessner J, Caca K. Long term failure of endoscopic gastroplication (EndoCinch). Gut 2005; 54:752-758.
66. Schiefke I, Neumann S, Zabel-Langhennig A, Moessner J, Caca K. Use of an endoscopic suturing device (the 'ESD') to treat patients with gastroesophageal reflux disease, after unsuccessful EndoCinch endoluminal gastroplication: another failure. Endoscopy 2005; 37:700-705.
67. Mahmood Z, Byrne PJ, McMahon BP, Murphy EM, Arfin Q, Ravi N, et al. Comparison of transesophageal endoscopic plication (TEP) with laparoscopic Nissen fundoplication (LNF) in the treatment of uncomplicated reflux disease. Am J Gastroenterol 2006; 101:431-436.
68. Domagk D, Menzel J, Seidel M, Ullerich H, Pohle T, Heinecke A, et al. Endoluminal gastroplasty (EndoCinch trade mark) versus endoscopic polymer implantation (Enteryx trade mark) for treatment of gastroesophageal reflux disease: 6-month results of a prospective, randomized trial. Am J Gastroenterol 2006; 101:422-430.
69. Chuttani R, Sud R, Sachdev G, Puri R, Kozarek R, Haber G, et al. A novel endoscopic full-thickness plicator for the treatment of GERD: a pilot study. Gastrointest Endosc 2003; 58:770-776.
70. Pleskow D, Rothstein R, Lo S, Hawes R, Kozarek R, Haber G, et al. Endoscopic full-thickness plication for the treatment of GERD: a multicenter trial. Gastrointest Endosc 2004; 59:163-171.
71. 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; 61:643-649.
72. 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; 21:439-444.
73. Schwartz MP, Welllink 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 2006; 21:439-444.
74. Rothstein R, Filipi C, Caca K, Pruitt R, Mergener K, Torquati A, et al. Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: a randomized, sham-controlled trial. Gastroenterology 2006; 131:704-712.
75. FDA Website: Manufactures and User Facility Device Experience Database (MAUDE). www.accessdata.gov/scripts/cdrh/efdocs/cfmaude/searchoptions = 1.
76. Terada T, Nakamura Y, Nakai K, Tsuura M, Nishiguchi T, Hayashi S, et al. Embolization of arteriovenous malformations with peripheral aneurysms using ethylene vinyl alcohol copolymer. Report of three cases. J Neurosurg 1991; 75:655-660.
77. Nishi S, Taki W, Nakahara I, Yamashita K, Sadatoh A, Kikuchi H, et al. Embolization of cerebral aneurysms with a liquid embolus, EVAL mixture: report of three cases. Acta Neurochir (Wien) 1996; 138:294-300.
78. Rustgi AK. Approval of Enteryx for GERD recommended by FDA panel. Gastroenterology 2003; 124:1725.
79. Noh KW, Loeb DS, Stockland A, Achem SR. Pneumomediastinum following Enteryx injection for the treatment of gastroesophageal reflux disease. Am J Gastroenterol 2005; 100:723-726.
80. Wong RF, Davis TV, Peterson KA. Complications involving the mediastinum after injection of Enteryx for GERD. Gastrointest Endosc 2005; 61:753-756.
81. Tintillier M, Chaput A, Kirch L, Martinet JP, Pochet JM, Cuvelier C. Esophageal abscess complicating endoscopic treatment of refractory gastroesophageal reflux disease by Enteryx injection: a first case report. Am J Gastroenterol 2004; 99:1856-1858.
82. http://www.bostonscientific.com/patient_ed/PEprocedureOverview.jsp?task =tskPEprocedureOverview.jsp&relId = 1002,1026§ionId = 3.
83. Ganz RA, Rydell M, Termin P. Accurate localization of tissue layers in the esophagus by using a double-lumen injection catheter: implications for the Enteryx procedure. Gastrointest Endosc 2006; 63:468-472.
84. Lemperle G, Gauthier-Hazan N, Lemperle M. PMMA-microspheres (artecoll) for long-lasting correction of wrinkles: refinements and statistical results. Aesthetic Plast Surg 1998; 22:356-365.
85. Velanovich V, Ben Menachem T. Laparoscopic Nissen fundoplication after failed endoscopic gastroplication. J Laparoendosc Adv Surg Tech A 2002; 12:305-308.
86. Tuebergen D, Rijcken E, Senninger N. Esophageal perforation as a complication of EndoCinch endoluminal gastroplication. Endoscopy 2004; 36:663-665.
87. Chadalavada R, Lin E, Swafford V, Sedghi S, Smith CD. Comparative results of endoluminal gastroplasty and laparoscopic antireflux surgery for the treatment of GERD. Surg Endosc 2004; 18:261-265.
88. Gordon C, Kang JY, Neild PJ, Maxwell JD. The role of the hiatus hernia in gastro-oesophageal reflux disease. Aliment Pharmacol Ther 2004; 20:719-732.
89. Orlando RC. Current understanding of the mechanisms of gastrooesophageal reflux disease. Drugs 2006; 66 (Suppl 1):1-5.
90. El Nakadi I, Closset J, De Moor V, Coppens E, Zalcman M, Deviere J, et al. Laparoscopic Nissen fundoplication after failure of Enteryx injection into the lower esophageal sphincter. Surg Endosc 2004; 18:818-820.
91. Pei Z, Bini EJ, Yang L, Zhou M, Francois F, Blaser MJ. Bacterial biota in the human distal esophagus. Proc Natl Acad Sci U S A 2004; 101:4250-4255.
92. Hogan WJ. Clinical trials evaluating endoscopic GERD treatments: is it time for a moratorium on the clinical use of these procedures? Am J Gastroenterol 2006; 101:437-439.
93. Chen YK. Endoscopic suturing devices for treatment of GERD: too little, too late? Gastrointest Endosc 2005; 62:44-47.
94. Wakelin DE, Sampliner RE. Endoscopic antireflux procedures: a good wrap? Clin Gastroenterol Hepatol 2005; 3:831-839.
95. Shaheen NJ. The rise and fall (and rise?) of endoscopic anti-reflux procedures. Gastroenterology 2006; 131:952-962.