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Original research
Gastric per-oral endoscopic myotomy (G-POEM) for refractory gastroparesis: results from an international prospective trial
  1. Kia Vosoughi1,
  2. Yervant Ichkhanian1,2,
  3. Petros Benias3,
  4. Larry Miller3,
  5. A Aziz Aadam4,
  6. Joseph R Triggs4,
  7. Ryan Law5,
  8. William Hasler5,
  9. Nicole Bowers5,
  10. Dalton Chaves6,
  11. Alberto M Ponte-Neto6,
  12. Peter Draganov7,
  13. Dennis Yang7,
  14. Maan El Halabi8,
  15. Omid Sanaei1,9,
  16. Olaya Isabella Brewer Gutierrez1,
  17. Robert Stephen Bulat1,
  18. John Pandolfino4,
  19. Mouen Khashab1
  1. 1Division of Gastroenterology and Hepatology, Johns Hopkins Medicine, Baltimore, Maryland, USA
  2. 2Department of Medicine, Henry Ford Health System, Detroit, Michigan, USA
  3. 3Division of Gastroenterology and Hepatology, Northwell Health, New Hyde Park, New York, USA
  4. 4Division of Gastroenterology and Hepatology, Northwestern Medicine, Chicago, Illinois, USA
  5. 5Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, Michigan, USA
  6. 6Division of Gastroenterology and Hepatology, Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo, Brazil
  7. 7Division of Gastroenterology, Hepatology and Nutrition, University of Florida Health, Gainesville, Florida, USA
  8. 8Department of Medicine, Mount Sinai Saint Luke's Hospital, New York, New York, USA
  9. 9Medicine, MedStar Union Memorial Hospital, Baltimore, Maryland, USA
  1. Correspondence to Dr Mouen Khashab, Division of Gastroenterology and Hepatology, Johns Hopkins Medicine, Baltimore, Maryland, USA; mkhasha1{at}jhmi.edu

Abstract

Objective Although gastric per-oral endoscopic myotomy (G-POEM) is considered a promising technique for the management of refractory gastroparesis, high-quality evidence is limited. We prospectively investigated the efficacy and safety of G-POEM in unselected patients with refractory gastroparesis.

Design In five tertiary centres, patients with symptomatic gastroparesis refractory to standard medical therapy and confirmed by impaired gastric emptying were included. The primary endpoint was clinical success, defined as at least one score decrease in Gastroparesis Cardinal Symptom Index (GCSI) with ≥25% decrease in two subscales, at 12 months. GCSI Score and subscales, adverse events (AEs) and 36-Item Short Form questionnaire of quality of life were evaluated at baseline and 1, 3, 6 and 12 months after G-POEM. Gastric emptying study was performed before and 3 months after the procedure.

Results Of 80 enrolled patients, 75 patients (94%) completed 12-month follow-up. Clinical success at 12 months was 56% (95% CI, 44.8 to 66.7). GCSI Score (including subscales) improved moderately after G-POEM (p<0.05). In a regression model, a baseline GCSI Score >2.6 (OR=3.23, p=0.04) and baseline gastric retention >20% at 4 hours (OR=3.65, p=0.03) were independent predictors of clinical success at 12 months, as was early response to G-POEM at 1 month after therapy (OR 8.75, p<0.001). Mild procedure-related AEs occurred in 5 (6%) patients.

Conclusion G-POEM is a safe procedure, but showed only modest overall effectiveness in the treatment of refractory gastroparesis. Further studies are required to identify the best candidates for G-POEM; unselective use of this procedure should be discouraged.

Trial registration number ClinicalTrials.gov Registry NCT02732821.

  • gastroparesis
  • gastrointesinal endoscopy
  • gastric emptying

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Footnotes

  • Twitter @JRTriggs, @Maanelhalabi

  • KV and YI contributed equally.

  • Contributors Study concept and design, analysis and interpretation of data and drafting of the manuscript: KV, YI and MK; acquisition of data: KV, YI, PB, LM, AAA, JRT, RL, NB, DC, AMP-N, PD, DY, OS and MK; critical revision of the manuscript for important intellectual content: all authors; statistical analysis: KV, YI, OS and MK and study supervision: MK.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests PB is a consultant for Medtronic. AAA is a consultant for Boston Scientific and Steris Endoscopy. RL is a consultant for Olympus America. WH is a consultant for Medtronic. PD is a consultant for Olympus, Boston Scientific, Cook, Lumendi, Microtech, Steris, Medtronic, Merit and Fujifilm. DY is a consultant for Lumendi and Steris. RSB reports that he is partially funded by the National Institutes of Health (NIH) Gastroparesis Research Consortium and he is a Johns Hopkins primary investigator in two multicentre pharmaceutical company sponsored trials for gastroparesis. JP holds stock options in Crospon and has a licensing agreement (Northwestern University gets $1000.00 per machine sold) with and is a speaker and consultant for Medtronic. MK is a consultant for Boston Scientific, Olympus and Medtronic and is on the medical advisory board for Boston Scientific and Olympus.

  • Patient consent for publication Not required.

  • Ethics approval This study was approved by the institutional research board of the corresponding centre and at each participating centre in accordance with their local regulations and performed in accordance with the Declaration of Helsinki and International Conference of Harmonisation (ICH) Good Clinical Practice Guidelines. The study was conducted at five tertiary centres (four USA, one South America) and was approved by the Institutional Review Board or its equivalent at Johns Hopkins Hospital and all other participating centres.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement No data are available.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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