PER ORAL ENDOSCOPIC PYLOROMYOTOMY (POP) IS EFFICIOUS AND SAFE FOR REFRACTORY GASTROPARESIS: THE FIRST PROSPECTIVE STUDY (GASTRO-POP- NCT02779920)

Aims:

Gastroparesis is a functional disorder with a variety of symptoms that is characterised by delayed gastric emptying in the absence of mechanical obstruction. A recent series of retrospective studies has demonstrated that per-oral endoscopic pyloromyotomy (POP) is a promising endoscopic procedure for treating refractory gastroparetic patients. Here we describe the first prospective study that evaluates the feasibility, safety, and efficacy of POP.

Methods:

A total of 20 refractory gastroparesis patients (10 diabetics and 10 non-diabetics) were prospectively included in this pilot trial (NCT02779920). They were treated by POP after pyloric function was evaluated using an endoscopic functional luminal imaging probe (EndoFLIP). Their clinical responses were evaluated using the Gastroparesis Cardinal Symptom Index (GCSI), and their quality of life was assessed using the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) and Gastrointestinal Quality of Life Index (GIQLI) scores. Gastric emptying was measured using 4h-scintigraphy before POP and at 3 months.

Results:

The feasibility of the procedure was 100%. POP significantly improved symptoms (GCSI: 1, 3 vs. 3, 5 p < 0.0001) and enhanced quality of life and gastric emptying (T½: 100 min vs. 345 min, p= 0.0007; % H2: 56% vs. 81.5%, p < 0.001; % H4: 15% vs. 57.5%, p= 0.0025) at 3 months. There were significant improvements in all cardinal symptoms following POP. The clinical success of POP using an EndoFLIP inflated at 50cc had a specificity of 100% and a sensitivity of 72.2% (p= 0.04; IC 95%: 0.509 – 0.935; AUC: 0.722) at a distensibility threshold of 9.2 mm²/mm Hg.

Conclusions:

We demonstrate the feasibility, safety, and efficacy of POP for treating severe refractory gastroparesis in this first prospective study. POP enhances gastric emptying in gastroparetic patients and significantly improves all major symptoms and quality of life at 3 months, especially in patients with low pyloric distensibility.