Skip to main content
SpringerLink
Log in

Systematic review and meta-analysis of controlled and prospective cohort efficacy studies of endoscopic radiofrequency for treatment of gastroesophageal reflux disease

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

Abstract

Background

The endoscopic radiofrequency procedure (Stretta) has been used for more than a decade to treat patients with gastroesophageal reflux disease (GERD). However, the efficacy of the procedure in improving objective and subjective clinical endpoints needs to be further established.

Aim

To determine the efficacy of the Stretta procedure in treating patients with GERD, using a systematic review and meta-analysis of controlled and cohort studies.

Methods

We conducted a systematic search of the PubMed and Cochrane databases for English language clinical studies of the Stretta procedure, published from inception until May 2016. Randomized controlled trials (RCTs) and cohort studies that included the use of the Stretta procedure in GERD patients were included. A generalized inverse weighting was used for all outcomes. Results were calculated by both fixed effects and random effects model.

Results

Twenty-eight studies (4 RCTs, 23 cohort studies, and 1 registry) representing 2468 unique Stretta patients were included in the meta-analysis. The (unweighted) mean follow-up time for the 28 studies was 25.4 [14.0, 36.7] months. The pooled results showed that the Stretta reduced (improved) the health-related quality of life score by −14.6 [−16.48, −12.73] (P < 0.001). Stretta also reduced (improved) the pooled heartburn standardized score by −1.53 [−1.97, −1.09] (P < 0.001). After Stretta treatment, only 49% of the patients using proton pump inhibitors (PPIs) at baseline required PPIs at follow-up (P < 0.001). The Stretta treatment reduced the incidence of erosive esophagitis by 24% (P < 0.001) and reduced esophageal acid exposure by a mean of −3.01 [−3.72, −2.30] (P < 0.001). Lower esophageal sphincter (LES) basal pressure was increased post Stretta therapy by a mean of 1.73 [−0.29, 3.74] mmHg (P = NS).

Conclusions

The Stretta procedure significantly improves subjective and objective clinical endpoints, except LES basal pressure, and therefore should be considered as a viable alternative in managing GERD.

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
Fig. 6
Fig. 7
Fig. 8

Similar content being viewed by others

References

  1. Maradey-Romero C, Fass R (2014) New and future drug development for gastroesophageal reflux disease. J Neurogastroenterol Motil 20(1):6–16

    Article  PubMed  Google Scholar 

  2. Locke GR III, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ III (1997) Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology 112(5):1448–1456

    Article  PubMed  Google Scholar 

  3. El-Serag HB, Sweet S, Winchester CC, Dent J (2014) Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut 63(6):871–880

    Article  PubMed  Google Scholar 

  4. Franciosa M, Triadafilopoulos G, Mashimo H (2013) Stretta radiofrequency treatment for GERD: a safe and effective modality. Gastroenterol Res Pract 2013:783–815

    Article  Google Scholar 

  5. Triadafilopoulos G (2014) Stretta: a valuable endoscopic treatment modality for gastroesophageal reflux disease. World J Gastroenterol 20(24):7730–7738

    Article  PubMed  PubMed Central  Google Scholar 

  6. Perry KA, Banerjee A, Melvin WS (2012) Radiofrequency energy delivery to the lower esophageal sphincter reduces esophageal acid exposure and improves GERD symptoms: a systematic review and meta-analysis. Surg Laparosc Endosc Percutan Tech 22(4):283–288

    Article  PubMed  Google Scholar 

  7. Lipka S, Kumar A, Richter JE (2015) No evidence for efficacy of radiofrequency ablation for treatment of gastroesophageal reflux disease: a systematic review and meta-analysis. Clin Gastroenterol Hepatol 13(6):1058.e1–1067.e1

  8. Higgins JP, Green S (2014) Cochrane handbook for systematic reviews of interventions. Online Kensaku 35(3):154–155

    Google Scholar 

  9. Moher D, Liberati A, Tetzlaff J, Altman DG (2009) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med 151(4):264–269

    Article  PubMed  Google Scholar 

  10. Velanovich V (2007) The development of the GERD-HRQL symptom severity instrument. Dis Esophagus 20(2):130–134

    Article  CAS  PubMed  Google Scholar 

  11. Velanovich V (1998) Comparison of generic (SF-36) vs. disease-specific (GERD-HRQL) quality-of-life scales for gastroesophageal reflux disease. J Gastrointest Surg 2(2):141–145

    Article  CAS  PubMed  Google Scholar 

  12. Hedges LV (1982) Statistical methodology in meta-analysis: ERIC Clearinghouse on Tests, Measurement and Evaluation. Report No.: ERIC/TM Report 83, December 1982. Princeton

  13. Higgins JP, Green S (2008) Cochrane handbook for systematic reviews of interventions. Wiley Online Library

  14. Wells G, Shea B, O’Connell D et al (2011) The Newcastle–Ottawa scale (NOS) for assessing the quality of nonrandomized studies in meta-analysis. The Ottawa Health Research Institute, Ottawa

    Google Scholar 

  15. Abdel-Latif A, Bolli R, Tleyjeh IM et al (2007) Adult bone marrow-derived cells for cardiac repair: a systematic review and meta-analysis. Arch Intern Med 167(10):989–997

    Article  PubMed  Google Scholar 

  16. Fu R, Vandermeer BW, Shamliyan TA et al (2014) Chapter 14: handling continuous outcomes in quantitative synthesis. In: Methods guide for effectiveness and comparative effectiveness reviews. Agency for Healthcare Research and Quality, Rockville, p 285–311

    Google Scholar 

  17. Hozo SP, Djulbegovic B, Hozo I (2005) Estimating the mean and variance from the median, range, and the size of a sample. BMC Med Res Methodol 5(1):13

    Article  PubMed  PubMed Central  Google Scholar 

  18. Balk EM, Earley A, Patel K, Trikalinos TA, Dahabreh IJ (2012) In: Agency for Healthcare Research and Quality (ed) Empirical assessment of within-arm correlation imputation in trials of continuous outcomes. Agency for Healthcare Research and Quality, Rockville

  19. Coron E, Sebille V, Cadiot G et al (2008) Clinical trial: radiofrequency energy delivery in proton pump inhibitor-dependent gastro-oesophageal reflux disease patients. Aliment Pharmacol Ther 28(9):1147–1158

    Article  CAS  PubMed  Google Scholar 

  20. The Agency for Healthcare Research and Quality (2014) In: The Agency for Healthcare Research and Quality (ed) Methods guide for effectiveness and comparative effectiveness reviews. The Agency for Healthcare Research and Quality, Rockville, p 384

  21. Liang WT, Yan C, Wang ZG et al (2015) Early and midterm outcome after laparoscopic fundoplication and a minimally invasive endoscopic procedure in patients with gastroesophageal reflux disease: a prospective observational study. J Laparoendosc Adv Surg Tech A 25(8):657–661

    Article  PubMed  Google Scholar 

  22. Triadafilopoulos G, DiBaise JK, Nostrant TT et al (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(2):149–156

    Article  PubMed  Google Scholar 

  23. Higuchi K, Fujiwara Y, Okazaki H et al (2007) Feasibility, safety, and efficacy of the Stretta procedure in Japanese patients with gastroesophageal reflux disease: first report from Asia. J Gastroenterol 42(3):205–210

    Article  PubMed  Google Scholar 

  24. Shrier I, Boivin J-F, Steele RJ et al (2007) Should meta-analyses of interventions include observational studies in addition to randomized controlled trials? A critical examination of underlying principles. Am J Epidemiol 166(10):1203–1209

    Article  PubMed  Google Scholar 

  25. Gregory D, Scotti D, Buck D, Triadafilopoulos G (2016) Budget impact analysis to estimate the cost dynamics of treating refractory gastroesophageal reflux disease with radiofrequency energy: a payer perspective. Manag Care (Langhorne Pa) 25(5):42

    Google Scholar 

  26. Arts J, Sifrim D, Rutgeerts P, Lerut A, Janssens J, Tack J (2007) 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 52(9):2170–2177

    Article  CAS  PubMed  Google Scholar 

  27. Arts J, Bisschops R, Blondeau K et al (2012) A double-blind sham-controlled study of the effect of radiofrequency energy on symptoms and distensibility of the gastro-esophageal junction in GERD. Am J Gastroenterol 107(2):222–230

    Article  CAS  PubMed  Google Scholar 

  28. Aziz AM, El-Khayat HR, Sadek A et al (2010) A prospective randomized trial of sham, single-dose Stretta, and double-dose Stretta for the treatment of gastroesophageal reflux disease. Surg Endosc 24(4):818–825

    Article  PubMed  Google Scholar 

  29. Cipolletta L, Rotondano G, Dughera L et al (2005) Delivery of radiofrequency energy to the gastroesophageal junction (Stretta procedure) for the treatment of gastroesophageal reflux disease. Surg Endosc 19(6):849–853

    Article  CAS  PubMed  Google Scholar 

  30. Corley DA, Katz P, Wo JM et al (2003) Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial. Gastroenterology 125(3):668–676

    Article  PubMed  Google Scholar 

  31. 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(4):833–842

    Article  PubMed  Google Scholar 

  32. Dughera L, Navino M, Cassolino P et al (2011) Long-term results of radiofrequency energy delivery for the treatment of GERD: results of a prospective 48-month study. Diagn Ther Endosc 2011:507157

    Article  PubMed  PubMed Central  Google Scholar 

  33. Dughera L, Rotondano G, De Cento M, Cassolino P, Cisaro F (2014) Durability of Stretta radiofrequency treatment for GERD: results of an 8-year follow-up. Gastroenterol Res Pract 2014:531907

    Article  PubMed  PubMed Central  Google Scholar 

  34. Dundon JM, Davis SS, Hazey JW, Narula V, Muscarella P, Melvin WS (2008) Radiofrequency energy delivery to the lower esophageal sphincter (Stretta procedure) does not provide long-term symptom control. Surg Innov 15(4):297–301

    Article  PubMed  Google Scholar 

  35. Gao X, Wang Z-g, Wu J-m et al (2011) Radiofrequency treatment on respiratory symptoms due to gastroesophageal reflux disease. Chin Med J (Engl) 124(7):1006–1009

    Google Scholar 

  36. Go MR, Dundon JM, Karlowicz DJ, Domingo CB, Muscarella P, Melvin WS (2004) Delivery of radiofrequency energy to the lower esophageal sphincter improves symptoms of gastroesophageal reflux. Surgery 136(4):786–794

    Article  PubMed  Google Scholar 

  37. Houston H, Khaitan L, Holzman M, Richards WO (2003) First year experience of patients undergoing the Stretta procedure. Surg Endosc 17(3):401–404

    Article  CAS  PubMed  Google Scholar 

  38. Liang WT, Wu JM, Wang F, Hu ZW, Wang ZG (2014) Stretta radiofrequency for gastroesophageal reflux disease-related respiratory symptoms: a prospective 5-year study. Minerva Chir 69(5):293–299

    CAS  PubMed  Google Scholar 

  39. Liu HF, Zhang JG, Li J, Chen XG, Wang WA (2011) Improvement of clinical parameters in patients with gastroesophageal reflux disease after radiofrequency energy delivery. World J Gastroenterol 17(39):4429–4433

    Article  PubMed  PubMed Central  Google Scholar 

  40. Lutfi R, Torquati A, Kaiser J, Holzman M, Richards W (2005) Three year’s experience with the Stretta procedure: Did it really make a difference? Surg Endosc Other Interv Tech 19(2):289–295

    Article  CAS  Google Scholar 

  41. Mansell DE (2001) Community practice evaluation of the effectiveness on the Stretta procedure for the treatment of GERD. Am J Gastroenterol 96(9):S21

    Article  Google Scholar 

  42. Meier PN, Nietzschmann T, Akin I, Klose S, Manns MP (2007) Improvement of objective GERD parameters after radiofrequency energy delivery: a European study. Scand J Gastroenterol 42(8):911–916

    Article  PubMed  Google Scholar 

  43. Noar MD, Lotfi-Emran S (2007) Sustained improvement in symptoms of GERD and antisecretory drug use: 4-year follow-up of the Stretta procedure. Gastrointest Endosc 65(3):367–372

    Article  PubMed  Google Scholar 

  44. Noar M, Squires P, Noar E, Lee M (2014) Long-term maintenance effect of radiofrequency energy delivery for refractory GERD: a decade later. Surg Endosc 28(8):2323–2333

    Article  PubMed  Google Scholar 

  45. Reymunde A, Santiago N (2007) 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 65(3):361–366

    Article  PubMed  Google Scholar 

  46. 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(5):638–647 (discussion 648–649)

  47. Tam WC, Schoeman MN, Zhang Q et al (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(4):479–485

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  48. 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(10):1475–1479

    Article  CAS  PubMed  Google Scholar 

  49. Wolfsen HC, Richards WO (2002) The Stretta procedure for the treatment of GERD: a registry of 558 patients. J Laparoendosc Adv Surg Tech A 12(6):395–402

    Article  Google Scholar 

  50. Glasziou P, Chalmers I, Rawlins M, McCulloch P (2007) When are randomised trials unnecessary? Picking signal from noise. BMJ 334(7589):349–351

    Article  PubMed  PubMed Central  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. The Esophageal and Swallowing Center, Division of Gastroenterology and Hepatology, Department of Medicine, The MetroHealth Medical Center and Case Western Reserve University, 2500 MetroHealth Drive, Cleveland, OH, 44109, USA

    Ronnie Fass

  2. BioMedical Strategies, La Jolla, CA, USA

    Frederick Cahn

  3. Alfred E. Driscoll Professor of Healthcare & Life Sciences Management, Fairleigh Dickinson University, Teaneck, NJ, USA

    Dennis J. Scotti

  4. Baker Tilly Virchow Krause, LLC, New York, NY, USA

    David A. Gregory

Authors
  1. Ronnie Fass
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Frederick Cahn
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Dennis J. Scotti
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. David A. Gregory
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Ronnie Fass.

Ethics declarations

Disclosures

Dennis J. Scotti is a Part-time Consultant with Baker Tilly Virchow Krause, LLC. Baker Tilly Virchow Krause, LLC is a Business Advisor to Mederi Therapeutics, Inc. David A. Gregory is a principal with Baker Tilly, a Business Advisor to Mederi Therapeutics. Frederick Cahn is a principal with BioMedical Strategies, a Business Advisor to Baker Tilly. Ronnie Fass is an Advisor to Ironwood and Mederi Therapeutics, Speaker for AstraZeneca, Dr. Reddy, Mederi Therapeutics and Takeda and receives Research Grant from Ironwood.

Appendices

Appendix 1: Modified Newcastle–Ottawa scoring system

We used the modified Newcastle–Ottawa scale to evaluate the following study characteristics, with the definition of exposure being Stretta treatment, and the measures of interest are the self-reported outcomes:

  • Representativeness of exposed cohort A = truly representative of the average patient with GERD, B = somewhat representative of the average patient with GERD, C = selected group and D = no description of the derivation of the cohort.

  • Selection of non-exposed cohort A = drawn from the same community as the exposed cohort, B = drawn from a different source and C = no description of the derivation of the non-exposed cohort.

  • Ascertainment of exposure A = secure record (e.g. surgical records), B = structured interview, C = written self-report and D = no description.

  • Demonstration that outcome of interest was not present at start of study (with respect to PPI use) A = yes, B = no, C = not applicable because outcome was not assessed at follow-up.

  • Comparability of cohorts on the basis of the design or analysis A = study controls for comorbidities, B = study controls for additional risk factors (such as age and severity of illness) and C = not done.

  • Assessment of outcome A = independent blind assessment, B = record linkage, C = self-report and D = no description.

  • Was follow-up long enough for outcomes to occur A = yes, and B = no.

  • Adequacy of follow-up of cohorts A = complete follow-up—all subjects accounted for, B = subjects lost to follow-up unlikely to introduce bias (small number lost), follow-up rate higher than 90% or description provided of those lost, C = follow-up rate 90% or lower and no description of those lost and D = no statement.

Appendix 2: Assessment of studies using the PICOTS framework

  1. 1.

    The patient population (“P”) in all trials were GERD patients. GERD is a common chronic and stable condition with a clinical context and natural history that is consistent with the criteria of Glasziou et al. [50] for the validity of non-randomized studies.

  2. 2.

    The intervention (“I”) is in all included studies a single physician-administered outpatient procedure using one specific device. Patient compliance was not a factor affecting treatment effectiveness.

  3. 3.

    In both RCT and cohort studies, the comparison (“C”) is a pre–post-treatment difference that directly measures a treatment effect. This design also reduces the risk of bias from confounding variables. Also, because of the stable natural history of GERD there is a low risk of bias due to regression-to-the-mean or spontaneous improvement. None of the studies use historical controls, which is known to have substantial risk of bias [24].

  4. 4.

    Both RCT and cohort studies report the same patient-reported effectiveness outcomes (“O”) (HRQL, heartburn score, PPI use) and in the case of erosive esophagitis an objective physician-measured effectiveness outcome.

  5. 5.

    The timeframe (“T”) of the treatment is short and the timeframe of follow-up is significant in terms of natural history of GERD. The follow-up times for the cohort studies overlap those of the RCT studies.

  6. 6.

    The setting (“S”) for the treatment in all studies is the outpatient clinic and the evaluation of HRQL, heartburn and PPI use is by the patient in the course of their normal activities. This setting matches that of normal clinical practice.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Fass, R., Cahn, F., Scotti, D.J. et al. Systematic review and meta-analysis of controlled and prospective cohort efficacy studies of endoscopic radiofrequency for treatment of gastroesophageal reflux disease. Surg Endosc 31, 4865–4882 (2017). https://doi.org/10.1007/s00464-017-5431-2

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00464-017-5431-2

Keywords

Search

Navigation