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Published in: Surgical Endoscopy 5/2007

01-05-2007

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

Authors: Alfonso Torquati, William O. Richards

Published in: Surgical Endoscopy | Issue 5/2007

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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.
Literature
1.
go back to reference 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: 11–2PubMedCrossRef 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: 11–2PubMedCrossRef
2.
go back to reference Pearl JP, Marks JM (2007) Endolumenal therapies for gastroesophageal reflux disease: are they dead? Surg Endosc 21: 1–4PubMedCrossRef Pearl JP, Marks JM (2007) Endolumenal therapies for gastroesophageal reflux disease: are they dead? Surg Endosc 21: 1–4PubMedCrossRef
3.
go back to reference 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: 1856–1858PubMedCrossRef 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: 1856–1858PubMedCrossRef
4.
go back to reference Wong RF, Davis TV, Peterson KA (2005) Complications involving the mediastinum after injection of Enteryx for GERD. Gastrointest Endosc 61: 753–756PubMedCrossRef Wong RF, Davis TV, Peterson KA (2005) Complications involving the mediastinum after injection of Enteryx for GERD. Gastrointest Endosc 61: 753–756PubMedCrossRef
5.
go back to reference 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: 682–689PubMedCrossRef 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: 682–689PubMedCrossRef
6.
go back to reference Swain P, Park PO, Mills T (2003) Bard EndoCinch: the device, the technique, and pre-clinical studies. Gastrointest Endosc Clin N Am 13: 75–88PubMedCrossRef Swain P, Park PO, Mills T (2003) Bard EndoCinch: the device, the technique, and pre-clinical studies. Gastrointest Endosc Clin N Am 13: 75–88PubMedCrossRef
7.
go back to reference Lutfi RE, Torquati A, Richards WO (2004) The endoscopic radiofrequency approach to management of GERD. Curr Opin Otolaryngol Head Neck Surg 12: 191–196PubMedCrossRef Lutfi RE, Torquati A, Richards WO (2004) The endoscopic radiofrequency approach to management of GERD. Curr Opin Otolaryngol Head Neck Surg 12: 191–196PubMedCrossRef
8.
go back to reference 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: 20–28PubMedCrossRef 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: 20–28PubMedCrossRef
9.
go back to reference 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: 1382–1389PubMedCrossRef 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: 1382–1389PubMedCrossRef
10.
go back to reference Schiefke I, Zabel-Langhennig A, Neumann S, Feisthammel J, Moessner J, Caca K (2005) Long term failure of endoscopic gastroplication (EndoCinch). Gut 54: 752–758PubMedCrossRef Schiefke I, Zabel-Langhennig A, Neumann S, Feisthammel J, Moessner J, Caca K (2005) Long term failure of endoscopic gastroplication (EndoCinch). Gut 54: 752–758PubMedCrossRef
11.
go back to reference 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: 34–39PubMedCrossRef 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: 34–39PubMedCrossRef
12.
go back to reference 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: 416–422PubMedCrossRef 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: 416–422PubMedCrossRef
13.
go back to reference Rothstein RI, Filipi CJ (2003) Endoscopic suturing for gastroesophageal reflux disease: clinical outcome with the Bard EndoCinch. Gastrointest Endosc Clin N Am 13: 89–101PubMedCrossRef Rothstein RI, Filipi CJ (2003) Endoscopic suturing for gastroesophageal reflux disease: clinical outcome with the Bard EndoCinch. Gastrointest Endosc Clin N Am 13: 89–101PubMedCrossRef
14.
go back to reference 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: 479–485PubMedCrossRef 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: 479–485PubMedCrossRef
15.
go back to reference 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: 833–842PubMedCrossRef 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: 833–842PubMedCrossRef
16.
go back to reference 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: 668–676PubMedCrossRef 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: 668–676PubMedCrossRef
17.
go back to reference 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: 149–156PubMedCrossRef 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: 149–156PubMedCrossRef
18.
go back to reference 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 648–9PubMedCrossRef 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 648–9PubMedCrossRef
19.
go back to reference 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: 849–853PubMedCrossRef 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: 849–853PubMedCrossRef
20.
go back to reference 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: 1475–1479PubMedCrossRef 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: 1475–1479PubMedCrossRef
21.
go back to reference 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: 770–776PubMedCrossRef 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: 770–776PubMedCrossRef
22.
go back to reference 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: 163–171PubMedCrossRef 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: 163–171PubMedCrossRef
23.
go back to reference 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: 704–712PubMedCrossRef 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: 704–712PubMedCrossRef
24.
go back to reference 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: 532–540PubMedCrossRef 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: 532–540PubMedCrossRef
25.
go back to reference 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: 1095–1100PubMedCrossRef 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: 1095–1100PubMedCrossRef
26.
go back to reference 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: 643–649PubMedCrossRef 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: 643–649PubMedCrossRef
27.
go back to reference Bammer T, Hinder RA, Klaus A, Klingler PJ (2001) Five- to eight-year outcome of the first laparoscopic Nissen fundoplications. J Gastrointest Surg 5: 42–48PubMedCrossRef Bammer T, Hinder RA, Klaus A, Klingler PJ (2001) Five- to eight-year outcome of the first laparoscopic Nissen fundoplications. J Gastrointest Surg 5: 42–48PubMedCrossRef
28.
go back to reference 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] 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.
go back to reference 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: 351–356PubMedCrossRef 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: 351–356PubMedCrossRef
Metadata
Title
Endoluminal GERD treatments: critical appraisal of current literature with evidence-based medicine instruments
Authors
Alfonso Torquati
William O. Richards
Publication date
01-05-2007
Publisher
Springer-Verlag
Published in
Surgical Endoscopy / Issue 5/2007
Print ISSN: 0930-2794
Electronic ISSN: 1432-2218
DOI
https://doi.org/10.1007/s00464-007-9344-3

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