Transoral incisionless fundoplication for treatment of gastroesophageal reflux disease in clinical practice

Bart P L Witteman, Rob Strijkers, Eva de Vries, Liza Toemen, José M Conchillo, Wim Hameeteman, Pieter C Dagnelie, Ger H Koek, Nicole D Bouvy, Bart P L Witteman, Rob Strijkers, Eva de Vries, Liza Toemen, José M Conchillo, Wim Hameeteman, Pieter C Dagnelie, Ger H Koek, Nicole D Bouvy

Abstract

Background: Transoral incisionless fundoplication is a recently introduced endoluminal technique for the treatment of gastroesophageal reflux disease (GERD). The objective of this study was to determine outcomes in chronic GERD patients who were referred for surgical management.

Methods: A cohort of 38 patients underwent transoral incisionless fundoplication (TIF) in a tertiary care setting. Pre- and post-procedure assessment included GERD-related quality of life questionnaires, proton pump inhibitor (PPI) usage, 24-h pH measurements, upper gastrointestinal endoscopy, esophageal manometry, and registration of adverse events. Duration of follow-up was 36 months.

Results: Gastroesophageal valves were constructed of 4 cm (range, 4-6) in length and 220° (range, 180-240) in circumference. One serious adverse event occurred, consisting of intraluminal bleeding at a fastener site. Hiatal hernia was completely reduced in 56 % and esophagitis was cured in 47 % of patients. Postprocedure esophageal acid exposure did not significantly improve (p > 0.05). At 36 (range, 29-41) months follow-up 14 patients (36 %) had undergone revisional laparoscopic fundoplication. Quality of life scores of the remaining cohort showed significant improvement (p < 0.0001) and daily use of antisecretory medication was discontinued by 74 %.

Conclusions: Endoluminal fundoplication improved quality of life and reduced the need for PPIs in only a subgroup of patients at 3 years follow-up. The amount of patients requiring additional medication and revisional surgery was high.

Figures

Fig. 1
Fig. 1
Study timeline

References

    1. Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006;101:1900–1920. doi: 10.1111/j.1572-0241.2006.00630.x.
    1. Jones R, Bytzer P. Review article: acid suppression in the management of gastro-oesophageal reflux disease—an appraisal of treatment options in primary care. Aliment Pharmacol Ther. 2001;15:765–772. doi: 10.1046/j.1365-2036.2001.00985.x.
    1. Spicak J. Treatment of gastroesophageal reflux disease: endoscopic aspects. Dig Dis. 2007;25:183–187. doi: 10.1159/000103882.
    1. Tytgat GN, McColl K, Tack J, Holtmann G, Hunt RH, Malfertheiner P, Hungin AP, Batchelor HK. New algorithm for the treatment of gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2008;27:249–256. doi: 10.1111/j.1365-2036.2007.03565.x.
    1. Garcia Rodriguez LA, Ruigomez A, Panes J. Use of acid-suppressing drugs and the risk of bacterial gastroenteritis. Clin Gastroenterol Hepatol. 2007;5:1418–1423. doi: 10.1016/j.cgh.2007.09.010.
    1. Lundell L. Surgery of gastroesophageal reflux disease: a competitive or complementary procedure? Dig Dis. 2004;22:161–170. doi: 10.1159/000080315.
    1. de Vries DR, van Herwaarden MA, Smout AJ, Samsom M. Gastroesophageal pressure gradients in gastroesophageal reflux disease: relations with hiatal hernia, body mass index, and esophageal acid exposure. Am J Gastroenterol. 2008;103:1349–1354. doi: 10.1111/j.1572-0241.2008.01909.x.
    1. Hirano I, Richter JE. ACG practice guidelines: esophageal reflux testing. Am J Gastroenterol. 2007;102:668–685. doi: 10.1111/j.1572-0241.2006.00936.x.
    1. Fass R. Proton-pump inhibitor therapy in patients with gastro-oesophageal reflux disease: putative mechanisms of failure. Drugs. 2007;67:1521–1530. doi: 10.2165/00003495-200767110-00001.
    1. Fass R, Shapiro M, Dekel R, Sewell J. Systematic review: proton-pump inhibitor failure in gastro-oesophageal reflux disease–where next? Aliment Pharmacol Ther. 2005;22:79–94. doi: 10.1111/j.1365-2036.2005.02531.x.
    1. Carlsson R, Dent J, Watts R, Riley S, Sheikh R, Hatlebakk J, Haug K, de Groot G, van Oudvorst A, Dalvag A, Junghard O, Wiklund I. Gastro-oesophageal reflux disease in primary care: an international study of different treatment strategies with omeprazole. International GORD Study Group. Eur J Gastroenterol Hepatol. 1998;10:119–124. doi: 10.1097/00042737-199802000-00004.
    1. Tutuian R, Vela MF, Hill EG, Mainie I, Agrawal A, Castell DO. Characteristics of symptomatic reflux episodes on acid suppressive therapy. Am J Gastroenterol. 2008;103:1090–1096. doi: 10.1111/j.1572-0241.2008.01791.x.
    1. Schwartz MP, Wellink 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. 2007;56:20–28. doi: 10.1136/gut.2006.096842.
    1. Corley DA, Katz P, Wo JM, Stefan A, Patti M, Rothstein R, Edmundowicz S, Kline M, Mason R, Wolfe MM. Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial. Gastroenterology. 2003;125:668–676. doi: 10.1016/S0016-5085(03)01052-7.
    1. Deviere J, Costamagna G, Neuhaus H, Voderholzer W, Louis H, Tringali A, Marchese M, Fiedler T, Darb-Esfahani P, Schumacher B. Nonresorbable copolymer implantation for gastroesophageal reflux disease: a randomized sham-controlled multicenter trial. Gastroenterology. 2005;128:532–540. doi: 10.1053/j.gastro.2004.12.005.
    1. 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. Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: a randomized, sham-controlled trial. Gastroenterology. 2006;131:704–712. doi: 10.1053/j.gastro.2006.07.004.
    1. Lopasso FP, Sakai P, Gazi BM, Artifon EL, Kfouri C, Souza JP, Kumar A. A pilot study to evaluate the safety, tolerance, and efficacy of a novel stationary antral balloon (SAB) for obesity. J Clin Gastroenterol. 2008;42:48–53. doi: 10.1097/01.mcg.0000247992.89215.88.
    1. Cadiere GB, Rajan A, Rqibate M, Germay O, Dapri G, Himpens J, Gawlicka AK. Endoluminal fundoplication (ELF)—evolution of EsophyX™, a new surgical device for transoral surgery. Minim Invasive Ther Allied Technol. 2006;15:348–355. doi: 10.1080/13645700601040024.
    1. Lundell LR, Dent J, Bennett JR, Blum AL, Armstrong D, Galmiche JP, Johnson F, Hongo M, Richter JE, Spechler SJ, Tytgat GN, Wallin L. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut. 1999;45:172–180. doi: 10.1136/gut.45.2.172.
    1. Cadiere GB, Buset M, Muls V, Rajan A, Rosch T, Eckardt AJ, Weerts J, Bastens B, Costamagna G, Marchese M, Louis H, Mana F, Sermon F, Gawlicka AK, Daniel MA, Deviere J. Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study. World J Surg. 2008;32(8):1676–1688. doi: 10.1007/s00268-008-9594-9.
    1. Cadiere GB, Rajan A, Germay O, Himpens J. Endoluminal fundoplication by a transoral device for the treatment of GERD: a feasibility study. Surg Endosc. 2008;22:333–342. doi: 10.1007/s00464-007-9618-9.
    1. Jobe BA, O’Rourke RW, McMahon BP, Gravesen F, Lorenzo C, Hunter JG, Bronner M, Kraemer SJM. Transoral endoscopic fundoplication in the treatment of gastroesophageal reflux disease: the anatomic and physiologic basis for reconstruction of the esophagogastric junction using a novel device. Ann Surg. 2008;248:69–76. doi: 10.1097/SLA.0b013e31817c9630.
    1. Velanovich V. The development of the GERD-HRQL symptom severity instrument. Dis Esophagus. 2007;20:130–134. doi: 10.1111/j.1442-2050.2007.00658.x.
    1. Velanovich V, Karmy-Jones R. Measuring gastroesophageal reflux disease: relationship between the health-related quality of life score and physiologic parameters. Am Surg. 1998;64:649–653.
    1. Velanovich V, Vallance SR, Gusz JR, Tapia FV, Harkabus MA. Quality of life scale for gastroesophageal reflux disease. J Am Coll Surg. 1996;183:217–224.
    1. Hunter JG, Trus TL, Branum GD, Waring JP, Wood WC. A physiologic approach to laparoscopic fundoplication for gastroesophageal reflux disease. Ann Surg. 1996;223:673–685. doi: 10.1097/00000658-199606000-00006.
    1. Linke GR, Borovicka J, Schneider P, Zerz A, Warschkow R, Lange J, Muller-Stich BP. Is a barium swallow complementary to endoscopy essential in the preoperative assessment of laparoscopic antireflux and hiatal hernia surgery? Surg Endosc. 2007;22(1):96–100. doi: 10.1007/s00464-007-9379-5.
    1. Moss SF, Kidd M, Modlin IM. The status of the hiatus: the role of hernia in gastroesophageal reflux disease. J Clin Gastroenterol. 2007;41:S144–S153. doi: 10.1097/MCG.0b013e31804bbe38.
    1. Boyce HW (1987) Hiatal hernia and peptic diseases of the esophagus. In: Sivak MV Jr (ed) Gastroenterologic endoscopy. WB Saunders, Philadelphia, pp 401–418
    1. Wolf BS. Sliding hiatal hernia: the need for redefinition. Am J Roentgenol Radium Ther Nucl Med. 1973;117:231–247.
    1. Jones MP, Sloan SS, Rabine JC, Ebert CC, Huang CF, Kahrilas PJ. Hiatal hernia size is the dominant determinant of esophagitis presence and severity in gastroesophageal reflux disease. Am J Gastroenterol. 2001;96:1711–1717. doi: 10.1111/j.1572-0241.2001.03926.x.
    1. Jobe BA, Kahrilas PJ, Vernon AH, Sandone C, Gopal DV, Swanstrom LL, Aye RW, Hill LD. Endoscopic appraisal of the gastroesophageal valve after antireflux surgery. Am J Gastroenterol. 2004;99:233–243. doi: 10.1111/j.1572-0241.2004.04042.x.
    1. Hill LD, Kozarek RA, Kraemer SJ, Aye RW, Mercer CD, Low DE, Pope CE., 2nd The gastroesophageal flap valve: in vitro and in vivo observations. Gastrointest Endosc. 1996;44:541–547. doi: 10.1016/S0016-5107(96)70006-8.
    1. Klinkenberg-Knol EC, Nelis F, Dent J, Snel P, Mitchell B, Prichard P, Lloyd D, Havu N, Frame MH, Roman J, Walan A. Long-term omeprazole treatment in resistant gastroesophageal reflux disease: efficacy, safety, and influence on gastric mucosa. Gastroenterology. 2000;118:661–669. doi: 10.1016/S0016-5085(00)70135-1.
    1. O’Connell MB, Madden DM, Murray AM, Heaney RP, Kerzner LJ. Effects of proton pump inhibitors on calcium carbonate absorption in women: a randomized crossover trial. Am J Med. 2005;118:778–781. doi: 10.1016/j.amjmed.2005.02.007.
    1. Cote GA, Howden CW. Potential adverse effects of proton pump inhibitors. Curr Gastroenterol Rep. 2008;10:208–214. doi: 10.1007/s11894-008-0045-4.
    1. Rice S, Watson DI, Lally CJ, Devitt PG, Game PA, Jamieson GG. Laparoscopic anterior 180 degrees partial fundoplication: five-year results and beyond. Arch Surg. 2006;141:271–275. doi: 10.1001/archsurg.141.3.271.
    1. Bammer T, Hinder RA, Klaus A, Klingler PJ. Five- to eight-year outcome of the first laparoscopic Nissen fundoplications. J Gastrointest Surg. 2001;5:42–48. doi: 10.1016/S1091-255X(01)80012-3.
    1. Falk GW, Fennerty MB, Rothstein RI. AGA Institute technical review on the use of endoscopic therapy for gastroesophageal reflux disease. Gastroenterology. 2006;131:1315–1336. doi: 10.1053/j.gastro.2006.08.019.
    1. Nieponice A, Jobe BA. Endoscopic fundoplication: real or fantasy? J Gastrointest Surg. 2011;15:1295–1298. doi: 10.1007/s11605-011-1580-0.
    1. 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. doi: 10.1111/j.1572-0241.2006.00523.x.
    1. Pearl JP, Marks JM. Endolumenal therapies for gastroesophageal reflux disease: are they dead? Surg Endosc. 2007;21:1–4. doi: 10.1007/s00464-006-0890-x.
    1. Cadiere GB, Van Sante N, Graves JE, Gawlicka AK, Rajan A. Two-year results of a feasibility study on antireflux transoral incisionless fundoplication using EsophyX. Surg Endosc. 2009;23:957–964. doi: 10.1007/s00464-009-0384-8.
    1. Repici A, Fumagalli U, Malesci A, Barbera R, Gambaro C, Rosati R. Endoluminal fundoplication (ELF) for GERD using EsophyX: a 12-month follow-up in a single-center experience. J Gastrointest Surg. 2010;14:1–6. doi: 10.1007/s11605-009-1077-2.
    1. Peters MJ, Mukhtar A, Yunus RM, Khan S, Pappalardo J, Memon B, Memon MA. Meta-analysis of randomized clinical trials comparing open and laparoscopic anti-reflux surgery. Am J Gastroenterol. 2009;104:1548–1561. doi: 10.1038/ajg.2009.176.

Source: PubMed

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