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Endoscopy 2018; 50(07): 708-725
DOI: 10.1055/a-0576-6589
Review
© Georg Thieme Verlag KG Stuttgart · New York

Efficacy of transoral incisionless fundoplication for refractory gastroesophageal reflux disease: a systematic review and meta-analysis

Thomas R. McCarty
1   Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, United States
,
Michael Itidiare
2   Division of Gastroenterology, Rowan University School of Osteopathic Medicine, Stratford, New Jersey, United States
,
Basile Njei
3   Section of Digestive Diseases, Yale University School of Medicine, New Haven, Connecticut, United States
,
Tarun Rustagi
4   Division of Gastroenterology and Hepatology, University of New Mexico, Albuquerque, New Mexico, United States
› Institutsangaben
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Publikationsverlauf

submitted 12. September 2017

accepted after revision 03. Januar 2018

Publikationsdatum:
06. April 2018 (online)

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Abstract

Background Given poor symptomatic response rates and rising awareness of the adverse events associated with the long-term use of proton pump inhibitors (PPIs), endoscopic modalities for treatment of refractory gastroesophageal reflux disease (GERD) have become more prominent. The aim of this study was to perform a systematic review and meta-analysis to evaluate feasibility, efficacy, and tolerability of transoral incisionless fundoplication (TIF) for the treatment of refractory GERD.

Methods Searches of PubMed, EMBASE, Web of Science, and Cochrane Library databases were performed to March 2017. Measured outcomes included immediate technical success rate and serious adverse events. Symptomatic improvement was measured using GERD Health-related Quality of Life (HRQL), Gastroesophageal Reflux Symptom Score (GERSS), and Reflux Symptom Index (RSI). Objective success was determined by hiatal hernia reduction and pH monitoring.

Results 32 studies (1475 patients; 48.2 % male) met inclusion criteria. TIF success rate was 99 % (95 % confidence interval [CI] 97 to 100; P < 0.001), with an adverse event rate of 2 % (95 %CI 1 to 3; P < 0.001). GERD HRQL, GERSS, and RSI improved significantly post-TIF (mean difference 17.72, 95 %CI 17.31 to 18.14; mean difference 23.78, 95 %CI 22.96 to 24.60; mean difference 14.28, 95 %CI 13.56 to 15.01; all P < 0.001, respectively). Hernia reduction occurred in 91 % of patients (95 %CI 83 to 98; P < 0.001). DeMeester scores improved significantly (mean difference 10.22, 95 %CI 8.38 to 12.12; P < 0.001). PPI therapy was discontinued post-procedure in 89 % of patients (95 %CI 82 to 95; P < 0.001).

Conclusions TIF appears to be a safe and effective endoscopic procedure for patients with refractory GERD. Future controlled trials are needed to directly compare efficacy, long-term durability, and safety between TIF and Nissen fundoplication.

 

  • References

  • 1 Zagari RM, Fuccio L, Wallander MA. et al. Gastro-oesophageal reflux symptoms, oesophagitis and Barrett’s oesophagus in the general population: the Loiano-Monghidoro study. Gut 2008; 57: 1354-1359
    CrossrefPubMedGoogle Scholar
  • 2 Camilleri M, Dubois D, Coulie B. et al. Prevalence and socioeconomic impact of upper gastrointestinal disorders in the United States: results of the US Upper Gastrointestinal Study. Clin Gastroenterol Hepatol 2005; 3: 543-552
    CrossrefPubMedGoogle Scholar
  • 3 El-Serag H, Becher A, Jones R. Systematic review: persistent reflux symptoms on proton pump inhibitor therapy in primary care and community studies. Aliment Pharmacol Ther 2010; 32: 720-737
    CrossrefPubMedGoogle Scholar
  • 4 Burak KW, Lee SS, Beck PL. Portal hypertensive gastropathy and gastric antral vascular ectasia (GAVE) syndrome. Gut 2001; 49: 866-872
    CrossrefPubMedGoogle Scholar
  • 5 Quintero E, Pique JM, Bombi JA. et al. Gastric mucosal vascular ectasias causing bleeding in cirrhosis. A distinct entity associated with hypergastrinemia and low serum levels of pepsinogen I. Gastroenterology 1987; 93: 1054-1061
    CrossrefPubMedGoogle Scholar
  • 6 Fass R. Proton-pump inhibitor therapy in patients with gastro-oesophageal reflux disease: putative mechanisms of failure. Drugs 2007; 67: 1521-1530
    CrossrefPubMedGoogle Scholar
  • 7 Lu M, Malladi V, Agha A. et al. Failures in a proton pump inhibitor therapeutic substitution program: lessons learned. Dig Dis Sci 2007; 52: 2813-2820
    CrossrefPubMedGoogle Scholar
  • 8 Garg SK, Gurusamy KS. Laparoscopic fundoplication surgery versus medical management for gastro-oesophageal reflux disease (GORD) in adults. Cochrane Database Syst Rev 2015; 11: CD003243
    PubMedGoogle Scholar
  • 9 Lamb PJ, Myers JC, Jamieson GG. et al. Long-term outcomes of revisional surgery following laparoscopic fundoplication. Br J Surg 2009; 96: 391-397
    CrossrefPubMedGoogle Scholar
  • 10 Granderath FA, Kamolz T, Granderath UM. et al. Gas-related symptoms after laparoscopic 360 degrees Nissen or 270 degrees Toupet fundoplication in gastrooesophageal reflux disease patients with aerophagia as comorbidity. Dig Liver Dis 2007; 39: 312-318
    CrossrefPubMedGoogle Scholar
  • 11 Davis CS, Fisichella PM. Laparoscopic Nissen fundoplication combined with posterior gastropexy in the surgical treatment of gastroesophageal reflux disease (GERD). Surg Endosc 2011; 25: 2055
    CrossrefPubMedGoogle Scholar
  • 12 Tsimogiannis KE, Pappas-Gogos GK, Benetatos N. et al. Laparoscopic Nissen fundoplication combined with posterior gastropexy in surgical treatment of GERD. Surg Endosc 2010; 24: 1303-1309
    CrossrefPubMedGoogle Scholar
  • 13 Cadiere GB, Rajan A, Rqibate M. et al. Endoluminal fundoplication (ELF) – evolution of EsophyX, a new surgical device for transoral surgery. Minim Invasive Ther Allied Technol 2006; 15: 348-355
    CrossrefPubMedGoogle Scholar
  • 14 Cadiere GB, Buset M, Muls V. et al. Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study. World J Surg 2008; 32: 1676-1688
    CrossrefPubMedGoogle Scholar
  • 15 Liberati A, Altman DG, Tetzlaff J. et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Ann Intern Med 2009; 151: W65-W94
    PubMedGoogle Scholar
  • 16 Jain D, Singhal S. Transoral incisionless fundoplication for refractory gastroesophageal reflux disease: where do we stand?. Clin Endosc 2016; 49: 147-156
    CrossrefPubMedGoogle Scholar
  • 17 Testoni PA, Mazzoleni G, Testoni SG. Transoral incisionless fundoplication for gastro-esophageal reflux disease: techniques and outcomes. World J Gastrointest Pharmacol Ther 2016; 7: 179-189
    CrossrefPubMedGoogle Scholar
  • 18 DerSimonian R, Laird N. Meta-analysis in clinical trials. Controlled Clin Trials 1986; 7: 177-188
    CrossrefPubMedGoogle Scholar
  • 19 Stuart A, Ord JK. Kendall’s advanced theory of statistics. 6th edn. London: Edward Arnold; 1994
    Google Scholar
  • 20 Trad KS, Fox MA, Simoni G. et al. Transoral fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with a crossover arm. Surg Endosc 2017; 31: 2498-2508
    CrossrefPubMedGoogle Scholar
  • 21 Stefanidis G, Viazis N, Kotsikoros N. et al. Long-term benefit of transoral incisionless fundoplication using the esophyx device for the management of gastroesophageal reflux disease responsive to medical therapy. Dis Esophagus 2017; 30: 1-8
    CrossrefPubMedGoogle Scholar
  • 22 Håkansson B, Montgomery M, Cadiere GB. et al. Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD. Aliment Pharmacol Ther 2015; 42: 1261-1270
    CrossrefPubMedGoogle Scholar
  • 23 Hunter JG, Kahrilas PJ, Bell RC. et al. Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterology 2015; 148: 324-333 e5
    CrossrefPubMedGoogle Scholar
  • 24 Roy-Shapira A, Bapaye A, Date S. et al. Trans-oral anterior fundoplication: 5-year follow-up of pilot study. Surg Endosc 2015; 29: 3717-3721
    CrossrefPubMedGoogle Scholar
  • 25 Testoni PA, Testoni S, Mazzoleni G. et al. Long-term efficacy of transoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-center study. Surg Endosc 2015; 29: 2770-2780
    CrossrefPubMedGoogle Scholar
  • 26 Witteman BP, Conchillo JM, Rinsma NF. et al. Randomized controlled trial of transoral incisionless fundoplication vs. proton pump inhibitors for treatment of gastroesophageal reflux disease. Am J Gastroenterol 2015; 110: 531-542
    CrossrefPubMedGoogle Scholar
  • 27 Zacherl J, Roy-Shapira A, Bonavina L. et al. Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE) for gastroesophageal reflux disease: 6-month results from a multi-center prospective trial. Surg Endosc 2015; 29: 220-229
    CrossrefPubMedGoogle Scholar
  • 28 Bell RC, Barnes WE, Carter BJ. et al. Transoral incisionless fundoplication: 2-year results from the prospective multicenter U.S. study. Am Surg 2014; 80: 1093-1105
    Google Scholar
  • 29 Rinsma NF, Smeets FG, Bruls DW. et al. Effect of transoral incisionless fundoplication on reflux mechanisms. Surg Endosc 2014; 28: 941-949
    CrossrefPubMedGoogle Scholar
  • 30 Toomey P, Teta A, Patel K. et al. Transoral incisionless fundoplication: is it as safe and efficacious as a Nissen or Toupet fundoplication?. Am Surg 2014; 80: 860-867
    CrossrefPubMedGoogle Scholar
  • 31 Wilson EB, Barnes WE, Mavrelis PG. et al. The effects of transoral incisionless fundoplication on chronic GERD patients: 12-month prospective multicenter experience. Surg Laparosc Endosc Percutan Tech 2014; 24: 36-46
    CrossrefPubMedGoogle Scholar
  • 32 Muls V, Eckardt AJ, Marchese M. et al. Three-year results of a multicenter prospective study of transoral incisionless fundoplication. Surg Innov 2013; 20: 321-330
    CrossrefPubMedGoogle Scholar
  • 33 Bell RC, Mavrelis PG, Barnes WE. et al. A prospective multicenter registry of patients with chronic gastroesophageal reflux disease receiving transoral incisionless fundoplication. J Am Coll Surg 2012; 215: 794-809
    CrossrefPubMedGoogle Scholar
  • 34 Narsule CK, Burch MA, Ebright MI. et al. Endoscopic fundoplication for the treatment of gastroesophageal reflux disease: initial experience. J Thorac Cardiovasc Surg 2012; 143: 228-234
    CrossrefPubMedGoogle Scholar
  • 35 Petersen RP, Filippa L, Wassenaar EB. et al. Comprehensive evaluation of endoscopic fundoplication using the EsophyX device. Surg Endosc 2012; 26: 1021-1027
    CrossrefPubMedGoogle Scholar
  • 36 Testoni PA, Vailati C, Testoni S. et al. Transoral incisionless fundoplication (TIF 2.0) with EsophyX for gastroesophageal reflux disease: long-term results and findings affecting outcome. Surg Endosc 2012; 26: 1425-1435
    CrossrefPubMedGoogle Scholar
  • 37 Trad KS, Turgeon DG, Deljkich E. Long-term outcomes after transoral incisionless fundoplication in patients with GERD and LPR symptoms. Surg Endosc 2012; 26: 650-660
    CrossrefPubMedGoogle Scholar
  • 38 Witteman BP, Strijkers R, de Vries E. et al. Transoral incisionless fundoplication for treatment of gastroesophageal reflux disease in clinical practice. Surg Endosc 2012; 26: 3307-3315
    CrossrefPubMedGoogle Scholar
  • 39 Frazzoni M, Conigliaro R, Manta R. et al. Reflux parameters as modified by EsophyX or laparoscopic fundoplication in refractory GERD. Aliment Pharmacol Ther 2011; 34: 67-75
    CrossrefPubMedGoogle Scholar
  • 40 Barnes WE, Hoddinott KM, Mundy S. et al. Transoral incisionless fundoplication offers high patient satisfaction and relief of therapy-resistant typical and atypical symptoms of GERD in community practice. Surg Innov 2011; 18: 119-129
    CrossrefPubMedGoogle Scholar
  • 41 Bell RC, Freeman KD. Clinical and pH-metric outcomes of transoral esophagogastric fundoplication for the treatment of gastroesophageal reflux disease. Surg Endosc 2011; 25: 1975-1984
    CrossrefPubMedGoogle Scholar
  • 42 Ihde GM, Besancon K, Deljkich E. Short-term safety and symptomatic outcomes of transoral incisionless fundoplication with or without hiatal hernia repair in patients with chronic gastroesophageal reflux disease. Am J Surg 2011; 202: 740-746
    CrossrefPubMedGoogle Scholar
  • 43 Nguyen A, Vo T, Nguyen XM. et al. Transoral incisionless fundoplication: initial experience in patients referred to an integrated academic institution. Am Surg 2011; 77: 1386-1389
    PubMedGoogle Scholar
  • 44 Svoboda P, Kantorova I, Kozumplik L. et al. Our experience with transoral incisionless plication of gastroesophageal reflux disease: NOTES procedure. Hepatogastroenterology 2011; 58: 1208-1213
    CrossrefPubMedGoogle Scholar
  • 45 Demyttenaere SV, Bergman S, Pham T. et al. Transoral incisionless fundoplication for gastroesophageal reflux disease in an unselected patient population. Surg Endosc 2010; 24: 854-858
    CrossrefPubMedGoogle Scholar
  • 46 Hoppo T, Immanuel A, Schuchert M. et al. Transoral incisionless fundoplication 2.0 procedure using EsophyX for gastroesophageal reflux disease. J Gastrointest Surg 2010; 14: 1895-1901
    CrossrefPubMedGoogle Scholar
  • 47 Repici A, Fumagalli U, Malesci A. et al. Endoluminal fundoplication (ELF) for GERD using EsophyX: a 12-month follow-up in a single-center experience. J Gastrointest Surg 2010; 14: 1-6
    PubMedGoogle Scholar
  • 48 Testoni PA, Corsetti M, Di Pietro S. et al. Effect of transoral incisionless fundoplication on symptoms, PPI use, and ph-impedance refluxes of GERD patients. World J Surg 2010; 34: 750-757
    CrossrefPubMedGoogle Scholar
  • 49 Velanovich V. Endoscopic, endoluminal fundoplication for gastroesophageal reflux disease: initial experience and lessons learned. Surgery 2010; 148: 646-651
    CrossrefPubMedGoogle Scholar
  • 50 Cadiere GB, Van Sante N, Graves JE. et al. Two-year results of a feasibility study on antireflux transoral incisionless fundoplication using EsophyX. Surg Endosc 2009; 23: 957-964
    CrossrefPubMedGoogle Scholar
  • 51 Finks JF, Wei Y, Birkmeyer JD. The rise and fall of antireflux surgery in the United States. Surg Endosc 2006; 20: 1698-1701
    CrossrefPubMedGoogle Scholar
  • 52 Louis H, Deviere J. Endoscopic implantation of enteryx for the treatment of gastroesophageal reflux disease: technique, pre-clinical and clinical experience. Gastrointest Endosc Clin N Am 2003; 13: 191-200
    CrossrefPubMedGoogle Scholar
  • 53 Cicala M, Gabbrielli A, Emerenziani S. et al. Effect of endoscopic augmentation of the lower oesophageal sphincter (Gatekeeper reflux repair system) on intraoesophageal dynamic characteristics of acid reflux. Gut 2005; 54: 183-186
    CrossrefPubMedGoogle Scholar
  • 54 Torquati A, Richards WO. Endoluminal GERD treatments: critical appraisal of current literature with evidence-based medicine instruments. Surg Endosc 2007; 21: 697-706
    CrossrefPubMedGoogle Scholar
  • 55 Montgomery M, Hakanson B, Ljungqvist O. et al. 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: 1382-1389
    CrossrefPubMedGoogle Scholar
  • 56 Pleskow D, Rothstein R, Kozarek R. et al. Endoscopic full-thickness plication for the treatment of GERD: five-year long-term multicenter results. Surg Endosc 2008; 22: 326-332
    CrossrefPubMedGoogle Scholar
  • 57 Fry LC, Monkemuller K, Malfertheiner P. Systematic review: endoluminal therapy for gastro-oesophageal reflux disease: evidence from clinical trials. Eur J Gastroenterol Hepatol 2007; 19: 1125-1139
    CrossrefPubMedGoogle Scholar
  • 58 Sami TradK. Transoral incisionless fundoplication: current status. Curr Opin Gastroenterol 2016; 32: 338-343
    CrossrefPubMedGoogle Scholar
  • 59 Funk LM, Zhang JY, Drosdeck JM. et al. Long-term cost-effectiveness of medical, endoscopic and surgical management of gastroesophageal reflux disease. Surgery 2015; 157: 126-136
    CrossrefPubMedGoogle Scholar
  • 60 Gerson LB, Trad KS, Lobontiu A. Efficacy of transoral incisionless fundoplication for gastroesophageal reflux disease: a meta-analysis. Gastroenterology 2016; 150 (Suppl. 01) S480
    PubMedGoogle Scholar
  • 61 Huang X, Chen S, Zhao H. et al. Efficacy of transoral incisionless fundoplication (TIF) for the treatment of GERD: a systematic review with meta-analysis. Surg Endosc 2017; 31: 1032-1044
    CrossrefPubMedGoogle Scholar