Gastric Peroral Endoscopic Pyloromyotomy is effective in the treatment of diabetic gastroparesis: Results from a randomized double-blinded sham-controlled trial

Aims To evaluate the effect of Endoscopic pyloromyotomy (G-POEM) in treatment of diabetic gastroparesis, we conducted a randomized double-blinded sham- controlled trial in diabetic patients diagnosed with gastroparesis.

Methods Prior to randomization, gastric retention of a mixed meal was evaluated by gastric emptying scintigraphy (GES) and during esophagogastroduodenoscopy (EGD) distensibility as measured by EndoFlip. The primary outcome was the alterations in GES, 3 months after G-POEM procedure. Complete remission was defined as gastric retention≤10%, 4 hours postprandially. Secondary outcomes included symptom relief assessed by Gastroparesis Cardinal Symptom Index (GCSI) and improvement in distensibility index (DI) after 3 months. Both patients and investigators were blinded to group allocation.

Results A total of 20 patients, 10 in each group, with diabetes, gastric retention>10% at 4 hours after a mixed meal, and a GCSI score≥1.9 were recruited between April 2023 and June 2024. In the sham group, one patient died due to a non-procedure-related heart attack. In the G-POEM group, one major adverse event occurred (duodenal perforation), which was managed laparoscopically. Eighteen patients completed the follow-up by August 2024. Remission Rates: Complete remission was achieved in 66.7% of patients (95% CI: 35%-88%) in the G-POEM group compared to 11% (95% CI: 2%-47%) in the sham group (p=0,050). Gastric Emptying Scintigraphy (GES): In the G-POEM group, 77.8% (95% CI: 45%-94%) experienced at least a 50% reduction in GES, with median 4-hour gastric retention decreasing from 24% (IQR: 19%-42%) to 8% (IQR: 4%-15%), p=0.021. No significant change was observed in the sham group (median 35%, IQR: 21%-50% before to 33%, IQR: 15%-57% after; p=0.91). The improvement in GES was significantly greater in G-POEM than in sham (p=0.045). Symptom Improvement (GCSI): All patients in the G-POEM group showed improvement, with the median GCSI decreasing from 2.35 (IQR: 2.00-3.55) to 0.88 (IQR: 0.53-1.20), p<0.001. In the sham group, no improvement was observed (median GCSI: 1.90, IQR: 1.90-3.75, to 2.40, IQR: 2.40-3.30, p=0.41). The difference in GCSI changes between groups was statistically significant (p<0.001). Distensibility Index (DI): The G-POEM group had a median increase in DI of 2.50 (IQR: 2.10-3.10), with DI scores rising from 4.40 (IQR: 1.80-4.40) to 6.45 (IQR: 5.35-7.60), p=0.009. The sham group experienced a median decrease of -0.85 (IQR: -1.75 to -0.18), with DI declining from 5.33 (IQR: 3.10-7.90) to 4.43 (IQR: 2.85-7.30), p=0.075. Between-group differences in DI changes were significant (p<0.001). G-POEM was the only significant predictor for remission. There was a significant association between GCSI and GES and negative association between GCSI and DI after intervention.

Conclusions G-POEM is superior to a sham procedure in improving gastric emptying, symptoms, and pyloric DI, making it a promising endoscopic treatment modality for diabetic gastroparesis.

Publication History

Article published online:
27 March 2025