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CC BY-NC-ND 4.0 · Endosc Int Open 2021; 09(06): E828-E835
DOI: 10.1055/a-1395-5667
Original article

Single session per oral endoscopic myotomy and trans oral incisionless fundoplication – can we prevent reflux in patients with achalasia?

Petros C. Benias
1   Division of Gastroenterology, Zucker School of Medicine at Hofstra/Northwell, Northwell Health System, Manhasset, New York, United States
,
Vivek Kumbhari
2   Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, MD, United States.
,
Nikhil A. Kumta
3   Division of Gastroenterology and Hepatology, Mount Sinai, New York, New York, United States.
,
Amrita Sethi
4   Division of Gastroenterology, Columbia University Medical Center, New York, New York.
,
Lionel S. D’Souza
5   Division of Gastroenterology and hepatology, Stony Brook School of Medicine, East Setauket, New York, United States
,
Amy Tyberg
6   Department of Gastroenterology, Rutgers Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States.
,
Olaya Brewer Gutierrez
2   Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, MD, United States.
,
Larry S. Miller
1   Division of Gastroenterology, Zucker School of Medicine at Hofstra/Northwell, Northwell Health System, Manhasset, New York, United States
,
David L. Carr-Locke
7   Division of Gastroenterology and Hepatology, Weil Cornell School of Medicine, New York Hospital, New York, New York, United States
,
Mouen A. Khashab
2   Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, MD, United States.
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Abstract

Background and study aims The rate of gastroesophageal reflux disease (GERD) after per oral endoscopic myotomy (POEM) is concerning. Endoscopic anti-reflux methods, such as Trans Oral Incisionless Fundoplication (TIF), are crucial for the long-term success of POEM, especially if they can be performed in the same session.

Methods We completed a proof-of-concept canine pilot study (n = 6) to assess safety and feasibility of POEM and TIF in a single session (POEM-TIF). Subsequently, POEM-TIF was also performed in patients with achalasia (n = 5). Herein, we report on the safety, technical and clinical success of the first-in-human cases with symptom follow-up at 1, 3 and 6 months and pH testing at 6 months.

Results POEM was completed successfully in six canines (3 anterior and 3 posterior myotomies), followed by TIF in the same session. Necropsy and extensive testing demonstrated no evidence of mucosal injury and no leaks. The reconstructed valve was 220 to 240 degrees, 3 to 4 cm in length, and resulted in concomitant esophageal lengthening (2–5 cm). Using similar principles, the first-in-human cases were performed without intraprocedural or delayed adverse events. pH testing at 6 months showed that four of five patients had no evidence of GERD (DeMeester > 14.72), and in one case, there was evidence of esophagitis.

Conclusions Single session POEM-TIF appears to be safe and feasible. Early clinical human data suggests that it may be able to reduce post POEM GERD, however the additional secondary benefits such as lengthening and straightening of the esophagus, may prove to be equally important for the long-term success of POEM.



Publication History

Received: 18 September 2020

Accepted: 12 November 2020

Article published online:
27 May 2021

© 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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  • References

  • 1 Khashab MA, Benias PC, Swanstrom LL. Endoscopic myotomy for foregut motility disorders. Gastroenterology 2018; 154: 1901-1910
    CrossrefPubMedGoogle Scholar
  • 2 Haito-Chavez Y, Inoue H, Beard KW. et al. Comprehensive analysis of adverse events associated with per oral endoscopic myotomy in 1826 patients: An international multicenter study. Am J Gastroenterol 2017; 112: 1267-1276
    CrossrefPubMedGoogle Scholar
  • 3 Kumbhari V, Familiari P, Bjerregaard NC. et al. Gastroesophageal reflux after peroral endoscopic myotomy: a multicenter case-control study. Endoscopy 2017; 49: 634-642
    Article in Thieme ConnectPubMedGoogle Scholar
  • 4 Repici A, Fuccio L, Maselli R. et al. GERD after per-oral endoscopic myotomy as compared with Heller's myotomy with fundoplication: a systematic review with meta-analysis. Gastrointest Endosc 2018; 87: 934-943
    CrossrefPubMedGoogle Scholar
  • 5 Campos GM, Vittinghoff E, Rabl C. et al. Endoscopic and surgical treatments for achalasia: a systematic review and meta-analysis. Ann Surg 2009; 249: 45-57
    CrossrefPubMedGoogle Scholar
  • 6 Rösch T, Repici A, Boeckxstaens G. Will reflux kill POEM?. Endoscopy 2017; 49: 625-628
    Article in Thieme ConnectPubMedGoogle Scholar
  • 7 Ichkhanian Y, Benias P, Khashab MA. A case of early Barrett cancer following peroral endoscopic myotomy. Gut 2019; 68: 2107-2110
    CrossrefPubMedGoogle Scholar
  • 8 Richards WO, Torquati A, Holzman MD. et al. Heller myotomy versus Heller myotomy with Dor fundoplication for achalasia: a prospective randomized double-blind clinical trial. Ann Surg 2004; 240: 405-412
    CrossrefPubMedGoogle Scholar
  • 9 Schlottmann F, Luckett DJ, Fine J. et al. Laparoscopic Heller myotomy versus peroral endoscopic myotomy (POEM) for achalasia: a systematic review and meta-analysis. Ann Surg 2018; 267: 451-460
    CrossrefPubMedGoogle Scholar
  • 10 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
    CrossrefPubMedGoogle Scholar
  • 11 Trad KS, Barnes WE, Simoni G. et al. Transoral incisionless fundoplication effective in eliminating GERD symptoms in partial responders to proton pump inhibitor therapy at 6 months: the TEMPO randomized clinical trial. Surg Innov 2015; 22: 26-40
    CrossrefPubMedGoogle Scholar
  • 12 Sami Trad K. Transoral incisionless fundoplication: current status. Curr Opin Gastroenterol 2016; 32: 338-343
    CrossrefPubMedGoogle Scholar
  • 13 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
  • 14 Tyberg A, Choi A, Gaidhane M. et al. Transoral incisional fundoplication for reflux after peroral endoscopic myotomy: a crucial addition to our arsenal. Endosc Int Open 2018; 6: E549-E552
    Article in Thieme ConnectPubMedGoogle Scholar
  • 15 Brewer Gutierrez OI, Benias PC, Khashab MA. Same-session per-oral endoscopic myotomy followed by transoral incisionless fundoplication in achalasia: Are we there yet?. Am J Gastroenterol 2020; 115: 162
    CrossrefPubMedGoogle Scholar
  • 16 Haruhiro I, Akiko U, Yuto S. et al. Peroral endoscopic myotomy and fundoplication: a novel NOTES procedure. Endoscopy 2019; 51: 161-164
    Article in Thieme ConnectPubMedGoogle Scholar