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.
- gastrointesinal endoscopy
- gastric emptying
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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.
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