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DOI: 10.1055/s-2008-1077511
© Georg Thieme Verlag KG Stuttgart · New York
Evaluation of a novel endoluminal stapling procedure to restrict the lower esophageal sphincter and reduce reflux
Publikationsverlauf
submitted 21 February 2008
accepted after revision 9 July 2008
Publikationsdatum:
04. September 2008 (online)
Background and study aims: An effective, safe, and long-lasting endoluminal treatment for gastroesophageal reflux disease (GERD) would be an attractive prospect. We developed an endoluminal technique to restrict and tighten the lower esophageal sphincter (LES), by using a transoral endoscopic stapling device in a porcine model.
Patients and methods: Pre-interventional evaluation comprised endoscopy, manometry, and 48-hour pH measurement of the distal esophagus using the catheterless BRAVO pH capsule. By placing the endoluminal stapling device at the LES and firing a 2.5-cm staple line, a vertical plication was created. In five pilot pigs (phase 1), plications were placed in various locations at the LES. In another five pigs (phase 2), plications were placed uniformly at the mid level of the LES on the lesser curvature side. Measurements were repeated 2 weeks after the procedure. Necropsy and histological analysis were performed.
Results: Endoluminal stapling was successfully completed in all animals. In phase 2, the median procedure time was 15 minutes (range 10 – 55 minutes). LES pressure increased from 10.5 mmHg (± 2.5mmHg) to 14.3 mmHg (± 3.8 mmHg) (P = 0.038). Median percentage of time with pH below 4 decreased from 6.6 % (range 2.9 % – 48.8 %) to 2.2 % (range 0 % – 10.4 %) (P = 0.043). Histology showed the staple line involving the muscular layer in all pigs. A gap was present in the central part of the staple line in three pigs resulting in a mucosa-muscular bridge of tissue. This bridge did not influence the results.
Conclusion: This novel endoluminal technique is feasible and safe in a porcine model over 2 weeks. It is appealing due to its simplicity and ease of application. Further studies aimed at eliminating the gap in the staple line and investigating more animals over longer survival periods are needed.
References
- 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
- 2 Mahon D, Rhodes M, Decadt B. et al . Randomized clinical trial of laparoscopic Nissen fundoplication compared with proton-pump inhibitors for treatment of chronic gastro-oesophageal reflux. Br J Surg. 2005; 92 695-699
- 3 Zaninotto G, Rizzetto C. Surgical options and outcomes in Barrett’s esophagus. Curr Opin Gastroenterol. 2007; 23 452-455
- 4 Hofstetter W L, Peters J H, DeMeester T R. et al . Long-term outcome of antireflux surgery in patients with Barrett’s esophagus. Ann Surg. 2001; 234 532-538; discussion 538 – 539
- 5 Vakil N, Shaw M, Kirby R. Clinical effectiveness of laparoscopic fundoplication in a U.S. community. Am J Med. 2003; 114 1-5
- 6 Morgenthal C B, Lin E, Shane M D. et al . Who will fail laparoscopic Nissen fundoplication? Preoperative prediction of long-term outcomes. Surg Endosc. 2007; 21 1978-1984
- 7 Lenglinger J, Ringhofer C, Eisler M. et al . Diagnosis of Gastroesophageal Reflux Disease (GERD). European Surgery. 2006; 38 227-243
- 8 Pandolfino J E, Richter J E, Ours T. et al . Ambulatory esophageal pH monitoring using a wireless system. Am J Gastroenterol. 2003; 98 740-749
- 9 Kahrilas P J, Quigley E M. Clinical esophageal pH recording: a technical review for practice guideline development. Gastroenterology. 1996; 110 1982-1996
- 10 Johnson L F, DeMeester T R. Development of the 24-hour intraesophageal pH monitoring composite scoring system. J Clin Gastroenterol. 1986; 8 (Suppl. 1) 52-58
- 11 Deviere J, Valdes G O, Herrera L C. et al . Safety, feasibility and weight loss after transoral gastroplasty: first human multicenter study. Surg Endosc. 2008; 22 589-598
- 12 Kahrilas P J, Lee T J. Gatekeeper reflux repair system; a mechanistic hypothesis. Gut. 2005; 54 179-180
- 13 Pandolfino J E, Shi G, Curry J. et al . Esophagogastric junction distensibility: a factor contributing to sphincter incompetence. Am J Physiol Gastrointest Liver Physiol. 2002; 282 G1052-1058
- 14 Watson A. An emerging trend in anti-reflux surgery?. ANZ J Surg. 2001; 71 252
- 15 Watson A, Jenkinson L R, Ball C S. et al . A more physiological alternative to total fundoplication for the surgical correction of resistant gastro-oesophageal reflux. Br J Surg. 1991; 78 1088-1094
- 16 Watson A, Spychal R T, Brown M G. et al . Laparoscopic ’physiological’ antireflux procedure: preliminary results of a prospective symptomatic and objective study. Br J Surg. 1995; 82 651-656
- 17 Watson D I, Jamieson G G, Lally C. et al . Multicenter, prospective, double-blind, randomized trial of laparoscopic nissen vs anterior 90 degrees partial fundoplication. Arch Surg. 2004; 139 1160-1167
- 18 Pandolfino J E, Lee T J, Schreiner M A. et al . Comparison of esophageal acid exposure at 1 cm and 6 cm above the squamocolumnar junction using the Bravo pH monitoring system. Dis Esophagus. 2006; 19 177-182
- 19 Liu J J, Glickman J N, Carr-Locke D L. et al . Gastroesophageal junction smooth muscle remodeling after endoluminal gastroplication. Am J Gastroenterol. 2004; 99 1895-1901
- 20 Stein H J, Liebermann-Meffert D, DeMeester T R, Siewert J R. Three-dimensional pressure image and muscular structure of the human lower esophageal sphincter. Surgery. 1995; 117 692-698
- 21 Pleskow D, Rothstein R, Kozarek R. et al . Endoscopic full-thickness plication for the treatment of GERD: long-term multicenter results. Surg Endosc. 2007; 21 439-444
- 22 Schiefke I, Zabel-Langhennig A, Neumann S. et al . Long term failure of endoscopic gastroplication (EndoCinch). Gut. 2005; 54 752-758
- 23 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
- 24 Schilling D, Kiesslich R, Galle P R, Riemann J F. Endoluminal therapy of GERD with a new endoscopic suturing device. Gastrointest Endosc. 2005; 62 37-43
- 25 Feitoza A B, Gostout C J, Rajan E. et al . Understanding endoluminal gastroplications: a histopathologic analysis of intraluminal suture plications. Gastrointest Endosc. 2003; 57 868-876
- 26 Cadiere G B, 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
- 27 Cadiere G B, 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
- 28 Corley D A, Katz P, Wo J M. et al . Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial. Gastroenterology. 2003; 125 668-676
- 29 Triadafilopoulos G, DiBaise J K, Nostrant T T. et al . The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the U.S. open label trial. Gastrointest Endosc. 2002; 55 149-156
-
30 FDA preliminary public health notification: recall of Boston Scientific Enteryx procedure kits and Enteryx injector single packs for treatment of gastroesophageal reflux disease (GERD). http://www.fda. gov/cdrh/safety/101405-enteryx.html. Accessed October 25, 2006.
- 31 Noh K W, Loeb D S, Stockland A, Achem S R. Pneumomediastinum following Enteryx injection for the treatment of gastroesophageal reflux disease. Am J Gastroenterol. 2005; 100 723-726
- 32 Tintillier M, Chaput A, Kirch L. et al . Esophageal abscess complicating endoscopic treatment of refractory gastroesophageal reflux disease by Enteryx injection: a first case report. Am J Gastroenterol. 2004; 99 1856-1858
- 33 Wong R F, Davis T V, Peterson K A. Complications involving the mediastinum after injection of Enteryx for GERD. Gastrointest Endosc. 2005; 61 753-756
B. W. Miedema, MD
Department of Surgery
University of Missouri
One Hospital Drive
Columbia, MO 65212
USA
Fax: +1-573-884-5049
eMail: miedemab@health.missouri.edu