Introduction
We previously reported 6 months results of a prospective, randomized and sham-controlled trial comparing endoscopic pyloromyotomy (G-POEM) with a sham procedure in patients with gastroparesis (GREG, 1). G-POEM was superior to a sham procedure in terms of both symptoms improvement and gastric emptying rate. Moreover, cross-over G-POEM, which was performed after a sham procedure was effective in 75% of patients. All patients have been prospectively followed according to an original protocol. Here, we report the long-term results. Unblinding of patients occurred 6 months after the originally allocated procedure (G-POEM or sham).
Aims & Methods
In GREG trial, G-POEM has been compared to a sham procedure in patients with refractory and severe gastroparesis (gastroparesis cardinal symptom index (GCSI) > 2.3, duration of symptoms of at least 6 months, with no adequate response to conservative measures). Patients randomized to the sham group with persistent symptoms were offered cross-over G-POEM. Symptoms were assessed in all enrolled patients (including those with a sham procedure only) at 12, 24 and 36 months, gastric emptying study and upper GI endoscopy were repeated at 12 months only in patients who underwent G-POEM (either primary or cross-over). The main outcomes were proportion of patients with treatment success and recurrences. Kaplan-Meier curve has been constructed to analyze the long-term effects.
Results
From a total of 41 randomized patients with gastroparesis (17 diabetic, 13 postsurgical, 11 idiopathic; 46% male), 33 patients received G-POEM (21 primary, 12 cross-over). Among these, median follow-up was 24 months and treatments success rates evolved from 72% (95% CI: 59%-90%) at 6 months to 67% (95% CI 52%-85%) at 12 months, 64% (49%-82%) at 24 months and 36 months. The corresponding numbers for diabetic, postsurgical and idiopathic gastroparesis at 36 months were 71% (51%-100%), 36% (17%-80%) and 78% (55%-100%). Overall, 3 patients (2 diabetic, 1 postsurgical) with previous treatment success experienced a recurrence of symptoms, however none of these patients required further intervention yet. One female patient with a primary treatment failure underwent redo G-POEM with treatment success (post-surgical etiology). Median gastric retention at 4 hours did not change between 3- and 12-months follow-up (6.7% to 10.0%). Seven patients underwent a sham procedure only, 4 achieving treatment success at 6 months. There were no symptomatic recurrencies up to 36 months follow-up. Among three “only sham” patients without a treatment success, one patient died from other reason and two patients who initially refused cross-over G-POEM decided to undergo this procedure later (one with treatment success, one is scheduled).
Conclusion
Endoscopic pyloromyotomy leads to a sustained improvement in approximately two thirds of patients with refractory GP and the rate of recurrencies is low. Diabetic and idiopathic GP showed a trend towards a higher long-term effect compared to postsurgical GP. Significant improvement of symptoms after sham procedure was infrequent but long-lasting.
References
Martinek J, Hustak R, Mares J, et al. Endoscopic pyloromyotomy for the treatment of severe and refractory gastroparesis: a pilot, randomised, sham-controlled trial. Gut 2022;71:2170–8.
