G-POEM improves gastroparesis symptoms, gastric emptying
Click Here to Manage Email Alerts
Endoscopic pyloromyotomy, also known as gastric peroral endoscopic myotomy, bested sham procedure in symptom improvement and gastric emptying among patients with severe and refractory gastroparesis, according to a presenter at UEG Week.
“Gastroparesis is defined by the delayed gastric emptying in the absence of mechanical obstruction. Severe gastroparesis increases mortality; the most common etiology are diabetic, postsurgical and idiopathic. The pathophysiology is multifactorial and not completely understood,” Rastislav Hustak, MD, of the Institute for Clinical and Experimental Medicine in Prague and University Hospital Trnava, Slovakia, said during a presentation. “Pylorospasm may play a role in the development of gastroparesis, and limited data has demonstrated some effectiveness of pylorus-directed therapies. ... Gastric peroral endoscopic myotomy (G-POEM) is a relatively new and promising procedure, but its effectiveness has not been proven.”
Previously reported to aid in achieved clinical success rates between 56% and 90%, Hustak added, researchers aimed to assess the safety and effectiveness of G-POEM among 41 patients (46% men; median age, 46 years) with severe and refractory gastroparesis (17 diabetic gastroparesis, 13 postsurgical gastroparesis and 11 idiopathic gastroparesis). In a prospective, randomized, single-blind trial, patients underwent symptom assessment, endoscopy and gastric emptying scintigraphy followed by G-POEM (n = 21) or sham procedure (n = 20); assessments occurred at baseline and 3 and 6 months. Patients who underwent sham procedure were offered crossover G-POEM at 6 months if their symptoms persisted. Studied endpoints included treatment success defined by improved gastric emptying and decreased Gastroparesis Cardinal Symptom Index (GCSI) score.
According to investigation, 88% of patients completed the 6-month follow-up with treatment success achieved in 74% (95% CI, 51-89) of patients in the G-POEM group and 18% (95% CI, 5-42) of patients in the sham procedure group. The G-POEM group also saw higher GCSI improvement from baseline to 6 months (3.5-1.2 vs. 3.2-2.6) and decreased median gastric retention at 4 hours (22%-7% vs. 22%-19%).
Among patients who underwent crossover from sham to G-POEM and completed 6-month follow-up (n = 10), 90% achieved treatment success (95% CI, 57-100). Researchers noted mean GCSI decreased from 3.2 following sham to 1.1 (P = .005) after G-POEM; they also saw a decrease in median gastric retention (20%-4%).
“Patients who underwent G-POEM had significantly improved gastric emptying while gastric emptying did not improve after the sham procedure. ... Endoscopic pyloromyotomy achieved higher treatment success compared with the sham procedure in all main theologies of gastroparesis. However, our study did not have sufficient power to show differences in subgroup analysis,” Hustak said. “G-POEM significantly improves symptoms 6 months after the procedure in patients with severe and refractory gastroparesis.”
Perspective
Back to Top
Matthew Allemang, MD
The importance of randomized blinded sham-controlled trials for endoscopic pyloric interventions for the treatment of gastroparesis cannot be understated. This study is a significant step forward.
Collapse
Hustak R, et al. Abstract OP005. Presented at: UEG Week; Oct. 3-5, 2021 (virtual meeting).
Read more about
Click Here to Manage Email Alerts