PMID- 33741641
OWN - NLM
STAT- MEDLINE
DCOM- 20220110
LR  - 20230411
IS  - 1468-3288 (Electronic)
IS  - 0017-5749 (Linking)
VI  - 71
IP  - 1
DP  - 2022 Jan
TI  - Gastric per-oral endoscopic myotomy (G-POEM) for refractory gastroparesis: 
      results from an international prospective trial.
PG  - 25-33
LID - 10.1136/gutjnl-2020-322756 [doi]
AB  - 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.
CI  - (c) Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and 
      permissions. Published by BMJ.
FAU - Vosoughi, Kia
AU  - Vosoughi K
AUID- ORCID: 0000-0002-6797-9386
AD  - Division of Gastroenterology and Hepatology, Johns Hopkins Medicine, Baltimore, 
      Maryland, USA.
FAU - Ichkhanian, Yervant
AU  - Ichkhanian Y
AD  - Division of Gastroenterology and Hepatology, Johns Hopkins Medicine, Baltimore, 
      Maryland, USA.
AD  - Department of Medicine, Henry Ford Health System, Detroit, Michigan, USA.
FAU - Benias, Petros
AU  - Benias P
AD  - Division of Gastroenterology and Hepatology, Northwell Health, New Hyde Park, New 
      York, USA.
FAU - Miller, Larry
AU  - Miller L
AD  - Division of Gastroenterology and Hepatology, Northwell Health, New Hyde Park, New 
      York, USA.
FAU - Aadam, A Aziz
AU  - Aadam AA
AD  - Division of Gastroenterology and Hepatology, Northwestern Medicine, Chicago, 
      Illinois, USA.
FAU - Triggs, Joseph R
AU  - Triggs JR
AD  - Division of Gastroenterology and Hepatology, Northwestern Medicine, Chicago, 
      Illinois, USA.
FAU - Law, Ryan
AU  - Law R
AD  - Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, 
      Michigan, USA.
FAU - Hasler, William
AU  - Hasler W
AD  - Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, 
      Michigan, USA.
FAU - Bowers, Nicole
AU  - Bowers N
AD  - Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, 
      Michigan, USA.
FAU - Chaves, Dalton
AU  - Chaves D
AD  - Division of Gastroenterology and Hepatology, Faculdade de Medicina, Universidade 
      de Sao Paulo, Sao Paulo, Sao Paulo, Brazil.
FAU - Ponte-Neto, Alberto M
AU  - Ponte-Neto AM
AD  - Division of Gastroenterology and Hepatology, Faculdade de Medicina, Universidade 
      de Sao Paulo, Sao Paulo, Sao Paulo, Brazil.
FAU - Draganov, Peter
AU  - Draganov P
AD  - Division of Gastroenterology, Hepatology and Nutrition, University of Florida 
      Health, Gainesville, Florida, USA.
FAU - Yang, Dennis
AU  - Yang D
AD  - Division of Gastroenterology, Hepatology and Nutrition, University of Florida 
      Health, Gainesville, Florida, USA.
FAU - El Halabi, Maan
AU  - El Halabi M
AD  - Department of Medicine, Mount Sinai Saint Luke's Hospital, New York, New York, 
      USA.
FAU - Sanaei, Omid
AU  - Sanaei O
AUID- ORCID: 0000-0002-3229-0626
AD  - Division of Gastroenterology and Hepatology, Johns Hopkins Medicine, Baltimore, 
      Maryland, USA.
AD  - Medicine, MedStar Union Memorial Hospital, Baltimore, Maryland, USA.
FAU - Brewer Gutierrez, Olaya Isabella
AU  - Brewer Gutierrez OI
AUID- ORCID: 0000-0001-6338-3801
AD  - Division of Gastroenterology and Hepatology, Johns Hopkins Medicine, Baltimore, 
      Maryland, USA.
FAU - Bulat, Robert Stephen
AU  - Bulat RS
AD  - Division of Gastroenterology and Hepatology, Johns Hopkins Medicine, Baltimore, 
      Maryland, USA.
FAU - Pandolfino, John
AU  - Pandolfino J
AD  - Division of Gastroenterology and Hepatology, Northwestern Medicine, Chicago, 
      Illinois, USA.
FAU - Khashab, Mouen
AU  - Khashab M
AUID- ORCID: 0000-0002-8011-0546
AD  - Division of Gastroenterology and Hepatology, Johns Hopkins Medicine, Baltimore, 
      Maryland, USA mkhasha1@jhmi.edu.
LA  - eng
SI  - ClinicalTrials.gov/NCT02732821
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Video-Audio Media
DEP - 20210319
PL  - England
TA  - Gut
JT  - Gut
JID - 2985108R
SB  - IM
CIN - Gut. 2023 May;72(5):1019-1020. PMID: 35697421
MH  - Female
MH  - Gastroparesis/*surgery
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - *Pyloromyotomy
MH  - Quality of Life
OTO - NOTNLM
OT  - gastric emptying
OT  - gastrointesinal endoscopy
OT  - gastroparesis
COIS- 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.
EDAT- 2021/03/21 06:00
MHDA- 2022/01/11 06:00
CRDT- 2021/03/20 06:04
PHST- 2020/08/07 00:00 [received]
PHST- 2021/03/03 00:00 [revised]
PHST- 2021/03/08 00:00 [accepted]
PHST- 2021/03/21 06:00 [pubmed]
PHST- 2022/01/11 06:00 [medline]
PHST- 2021/03/20 06:04 [entrez]
AID - gutjnl-2020-322756 [pii]
AID - 10.1136/gutjnl-2020-322756 [doi]
PST - ppublish
SO  - Gut. 2022 Jan;71(1):25-33. doi: 10.1136/gutjnl-2020-322756. Epub 2021 Mar 19.