Article Text

Original research
Endoscopic pyloromyotomy for the treatment of severe and refractory gastroparesis: a pilot, randomised, sham-controlled trial
  1. Jan Martinek1,
  2. Rastislav Hustak2,3,
  3. Jan Mares4,
  4. Zuzana Vackova1,
  5. Julius Spicak1,
  6. Eva Kieslichova5,
  7. Marie Buncova6,
  8. Daniel Pohl7,
  9. Sunil Amin8,
  10. Jan Tack9
  1. 1 Department of Hepatogastroenterology, Institute of Clinical and Experimental Medicine, Praha, Czech Republic
  2. 2 Department of Internal Medicine, University Hospital Trnava, Trnava, Slovakia
  3. 3 Institute of Physiology, Charles University in Prague, Prague, Czech Republic
  4. 4 Department of IT and Biostatistics, Institute of Clinical and Experimental Medicine, Praha, Czech Republic
  5. 5 Department of Anesthesiology and Intensive Care, Institute of Clinical and Experimental Medicine, Praha, Czech Republic
  6. 6 Department of Nuclear Medicine, Institute of Clinical and Experimental Medicine, Praha, Czech Republic
  7. 7 Division of Gastroenterology & Hepatology, University Hospital Zürich, Zürich, Switzerland
  8. 8 Division of Gastroenterology, University of Miami Miller School of Medicine, Miami, Florida, USA
  9. 9 Clinical and Experimental Medicine, University of Leuven, Leuven, Belgium
  1. Correspondence to Professor Jan Martinek, Department of Hepatogastroenterology, Institute of Clinical and Experimental Medicine, Praha 140 21, Czech Republic; jan.martinek{at}volny.cz

Abstract

Objective Endoscopic pyloromyotomy (G-POEM) is a minimally invasive treatment option with promising uncontrolled outcome results in patients with gastroparesis.

Design In this prospective randomised trial, we compared G-POEM with a sham procedure in patients with severe gastroparesis. The primary outcome was the proportion of patients with treatment success (defined as a decrease in the Gastroparesis Cardinal Symptom Index (GCSI) by at least 50%) at 6 months. Patients randomised to the sham group with persistent symptoms were offered cross-over G-POEM.

Results The enrolment was stopped after the interim analysis by the Data and Safety Monitoring Board prior to reaching the planned sample of 86 patients. A total of 41 patients (17 diabetic, 13 postsurgical, 11 idiopathic; 46% male) were randomised (21 G-POEM, 20-sham). Treatment success rate was 71% (95% CI 50 to 86) after G-POEM versus 22% (8–47) after sham (p=0.005). Treatment success in patients with diabetic, postsurgical and idiopathic gastroparesis was 89% (95% CI 56 to 98), 50% (18–82) and 67% (30–90) after G-POEM; the corresponding rates in the sham group were 17% (3–57), 29% (7–67) and 20% (3–67).

Median gastric retention at 4 hours decreased from 22% (95% CI 17 to 31) to 12% (5–22) after G-POEM and did not change after sham: 26% (18–39) versus 24% (11–35). Twelve patients crossed over to G-POEM with 9 of them (75%) achieving treatment success.

Conclusion In severe gastroparesis, G-POEM is superior to a sham procedure for improving both symptoms and gastric emptying 6 months after the procedure. These results are not entirely conclusive in patients with idiopathic and postsurgical aetiologies.

Trial registration number NCT03356067; ClinicalTrials.gov.

  • GASTROPARESIS
  • GASTRIC EMPTYING

Data availability statement

Data are available upon reasonable request.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Data availability statement

Data are available upon reasonable request.

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Footnotes

  • Twitter @SunilAminMD

  • Contributors JMartinek: study concept and study design, patient’s recruitment, performing all G-POEM procedures, follow-up endoscopies, drafting the manuscript; the guarantor. RH: study design, data collection, assisting the procedures, follow-up endoscopies, drafting the manuscript. JMares: statistical analysis, study design, drafting the manuscript. ZV: patient’s recruitment and selection, measurement and analysis of pyloric distensibility measurement, follow-up endoscopies, critical review of the manuscript. JS: follow-up endoscopies, critical review of the manuscript. EK: anaesthesia during procedures, analysis of AEs, critical review of the manuscript. MB: gastric emptying studies—analysis and critical review of the manuscript. DP: Endoflip measurement and analysis, study design. SA: critical review of the manuscript, advisor. JT: study concept, study design, data analysis and interpretation, critical review of the manuscript.

  • Funding The work was supported by a Grant 17-28797A from the Czech Ministry of Health.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

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

  • 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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