Long-term outcomes of patients with refractory gastroesophageal reflux disease following a minimally invasive endoscopic procedure: a prospective observational study

BMC Gastroenterology

Ji-Min Wu²  Chao Zhang²  Guang-Chang Zhu²  Jian-Jun Liu²  Zhi-Wei Hu²  Yue Yang²  Feng Wang²  Zhong-Gao Wang¹  Wei-Tao Liang¹ 

[1] Department of Vascular Surgery, Xuan Wu Hospital, Capital Medical University, Beijing, China;Department of Gastroesophageal Reflux Disease, Second Artillery General Hospital of the Chinese People’s Liberation Army, 16 Xinwai Street, Xicheng District, Beijing 100088, China

关键词: Long-term outcomes;    Radiofrequency delivery;    Stretta procedure;    Gastroesophageal reflux disease (GERD);   

Others  :  1121783
DOI  :  10.1186/1471-230X-14-178

 received in 2014-02-04, accepted in 2014-09-29,  发布年份 2014

【 摘 要 】

Background

Gastroesophageal reflux disease (GERD) is the most common digestive disease, affecting one third of the world’s population. The minimally invasive endoscopic Stretta procedure is being increasingly used as an alternative strategy to manage refractory GERD. However, long-term benefits of this procedure have to be further evaluated in clinical settings. This prospective observational study was therefore conducted to evaluate the outcome of patients with refractory GERD 5 years after the Stretta procedure.

Methods

A total of 152 patients with refractory GERD underwent the Stretta procedure in our department between April 2007 and September 2008. They were followed up for 5 years, during which the primary outcome measures including symptom scores of heartburn, regurgitation, chest pain, cough and asthma and the secondary outcome measures including proton pump inhibitor (PPI) use and patients’ satisfaction were analysed at 6, 12, 24, 36, 48 and 60 months respectively.

Results

Of the 152 patients, 138 completed the designated 5-year follow-up and were included in the final analysis. At the end of the 5-year follow-up, the symptom scores of heartburn (2.47 ± 1.22 vs. 5.86 ± 1.52), regurgitation (2.23 ± 1.30 vs. 5.56 ± 1.65), chest pain (2.31 ± 0.76 vs. 4.79 ± 1.59), cough (3.14 ± 1.43 vs. 6.62 ± 1.73) and asthma (3.26 ± 1.53 vs. 6.83 ± 1.46) were all significantly decreased as compared with the corresponding values before the procedure (P < 0.001). After the Stretta procedure, 59 (42.8%) patients achieved complete PPI therapy independence and 104 (75.4%) patients were completely or partially satisfied with the GERD symptom control. Moreover, no severe complications were observed except for complaint of abdominal distention in 12 (8.7%) patients after the Stretta procedure.

Conclusion

The Stretta procedure may achieve an effective and satisfactory long-term symptom control and considerably reduce the reliance on medication without significant adverse effects in adult patients with refractory GERD, thereby having profound clinical implications.

【 授权许可】

   
2014 Liang et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

Figure 4.

Figure 5.

Figure 6.

【 参考文献 】

• [1]Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R, Global Consensus G: The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol 2006, 101(8):1900-1920. quiz 1943
• [2]Franciosa M, Mashimo H: Stretta radiofrequency treatment for GERD: a safe and effective modality. Am J Gastroenterol 2013, 108(10):1654-1655.
• [3]Talley NJ, Wiklund I: Patient reported outcomes in gastroesophageal reflux disease: an overview of available measures. Qual Life Res 2005, 14(1):21-33.
• [4]DeVault KR, Castell DO, American College of G: Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J Gastroenterol 2005, 100(1):190-200.
• [5]Hershcovici T, Fass R: Pharmacological management of GERD: where does it stand now? Trends Pharmacol Sci 2011, 32(4):258-264.
• [6]Chapman DB, Rees CJ, Lippert D, Sataloff RT, Wright SC Jr: Adverse effects of long-term proton pump inhibitor use: a review for the otolaryngologist. J Voice 2011, 25(2):236-240.
• [7]Cicala M, Emerenziani S, Guarino MP, Ribolsi M: Proton pump inhibitor resistance, the real challenge in gastro-esophageal reflux disease. World J Gastroenterol 2013, 19(39):6529-6535.
• [8]Moraes-Filho JP: Refractory gastroesophageal reflux disease. Arq Gastroenterol 2012, 49(4):296-301.
• [9]Franciosa M, Triadafilopoulos G, Mashimo H: Stretta Radiofrequency Treatment for GERD: A Safe and Effective Modality. Gastroenterol Res Pract 2013, 2013:783815.
• [10]Broeders JA, Roks DJ, Ahmed Ali U, Watson DI, Baigrie RJ, Cao Z, Hartmann J, Maddern GJ: Laparoscopic anterior 180-degree versus nissen fundoplication for gastroesophageal reflux disease: systematic review and meta-analysis of randomized clinical trials. Ann Surg 2013, 257(5):850-859.
• [11]Thomas H, Agrawal S: Systematic review of day-case laparoscopic fundoplication. J Laparoendosc Adv Surg Tech A 2011, 21(9):781-788.
• [12]Niebisch S, Peters JH: Update on fundoplication for the treatment of GERD. Curr Gastroenterol Rep 2012, 14(3):189-196.
• [13]Richter JE: Gastroesophageal reflux disease treatment: side effects and complications of fundoplication. Clin Gastroenterol Hepatol 2013, 11(5):465-471. quiz e439
• [14]Freston JW, Triadafilopoulos G: Review article: approaches to the long-term management of adults with GERD-proton pump inhibitor therapy, laparoscopic fundoplication or endoscopic therapy? Aliment Pharmacol Ther 2004, 19(Suppl 1):35-42.
• [15]FDA 2000. http://www.accessdata.fda.gov/cdrh_docs/pdf10/K103017.pdf webcite
• [16]Utley DS: The Stretta procedure: device, technique, and pre-clinical study data. Gastrointest Endosc Clin N Am 2003, 13(1):135-145.
• [17]Arts J, Bisschops R, Blondeau K, Farre R, Vos R, Holvoet L, Caenepeel P, Lerut A, Tack J: 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 2012, 107(2):222-230.
• [18]Dundon JM, Davis SS, Hazey JW, Narula V, Muscarella P, Melvin WS: Radiofrequency energy delivery to the lower esophageal sphincter (Stretta procedure) does not provide long-term symptom control. Surg Innov 2008, 15(4):297-301.
• [19]Dyster-Aas J, Kildal M, Willebrand M: Return to work and health-related quality of life after burn injury. J Rehabil Med 2007, 39(1):49-55.
• [20]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(3):367-372.
• [21]Perry KA, Banerjee A, Melvin WS: 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 2012, 22(4):283-288.
• [22]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(3):361-366.
• [23]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: 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(2):149-156.
• [24]Gao X, Wang ZG, Wu JM, Ji F, Zhang CC, Ning YC, Li ZT, Hu ZW, Chen X, Tian SR: Radiofrequency treatment on respiratory symptoms due to gastroesophageal reflux disease. Chin Med J (Engl) 2011, 124(7):1006-1009.
• [25]Dughera L, Navino M, Cassolino P, De Cento M, Cacciotella L, Cisaro F, Chiaverina M: Long-Term Results of Radiofrequency Energy Delivery for the Treatment of GERD: Results of a Prospective 48-Month Study. Diagn Ther Endosc 2011, 2011:507157.
• [26]Fanelli RD, Gersin KS, Bakhsh A: The Stretta procedure: effective endoluminal therapy for GERD. Surg Technol Int 2003, 11:129-134.
• [27]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(6):395-402.
• [28]Roberts JR, Aravapalli A, Pohl D, Freeman J, Castell DO: Extraesophageal gastroesophageal reflux disease (GERD) symptoms are not more frequently associated with proximal esophageal reflux than typical GERD symptoms. Dis Esophagus 2012, 25(8):678-681.
• [29]Meier PN, Nietzschmann T, Akin I, Klose S, Manns MP: Improvement of objective GERD parameters after radiofrequency energy delivery: a European study. Scand J Gastroenterol 2007, 42(8):911-916.
• [30]Kim WH, Park PW, Hahm KB, Hong SP: Endoscopic treatment of refractory gastroesohageal reflux disease. Clin Endosc 2013, 46(3):230-234.
• [31]Liu HF, Zhang JG, Li J, Chen XG, Wang WA: Improvement of clinical parameters in patients with gastroesophageal reflux disease after radiofrequency energy delivery. World J Gastroenterol 2011, 17(39):4429-4433.
• [32]Kim MS, Holloway RH, Dent J, Utley DS: Radiofrequency energy delivery to the gastric cardia inhibits triggering of transient lower esophageal sphincter relaxation and gastroesophageal reflux in dogs. Gastrointest Endosc 2003, 57(1):17-22.
• [33]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(4):479-485.
• [34]Noar MD, Noar E: Gastroparesis associated with gastroesophageal reflux disease and corresponding reflux symptoms may be corrected by radiofrequency ablation of the cardia and esophagogastric junction. Surg Endosc 2008, 22(11):2440-2444.
• [35]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 gastroesophagal reflux disease. Dig Dis Sci 2007, 52(9):2170-2177.