Table 1

Demographic and clinical characteristics of the patients at baseline

CharacteristicG-POEM armControl (sham) arm
Number of patients2120
Sex—number (%)
 Female11 (52.4)11 (55.0)
 Male10 (47.6)9 (45.0)
Age—median (Q1–Q3) (years)43 (30 – 51)51 (45 – 56)
BMI – median (Q1–Q3)(kg/m2)22 (19 – 28)26 (21 – 28)
Aetiology—number (%)
 Diabetic; (diabetes type I/diabetes type II, number)9 (42.9); (8/1)8 (40.0); (6/2)
 Post-surgical6 (28.6)7 (35.0)
 Idiopathic6 (28.6)5 (25.0)
Previous therapy—number (%)
 Metoclopramide12 (57.1)10 (50.0)
 Itopride11 (52.4)10 (50.0)
 Domperidone9 (42.9)7 (35.0)
 Other prokinetics3 (14.3)2 (10.0)
 Enteral feeding via nasojejunal/nasogastric tube3 (14.3)1 (5.0)
 Recurrent hospitalisation for gastroparesis-related symptom8 (38.1)7 (35.0)
Baseline GCSI score—median (Q1–Q3)*3.5 (3.2–3.7)3.2 (2.6–3.4)
Baseline PAGI-QOL score—median (Q1–Q3)†2.1 (1.7–2.7)2.5 (1.4–2.8)
Baseline 4 hours GES retention—median (Q1–Q3)(%)‡22 (17–32)26 (16–42)
Pre-procedure DI 40 mL—median (Q1–Q3)(mm2/mm Hg)§5.8 (4.8–9.8)5.6 (3.5–6.2)
  • Q1–Q3—the first and the third quartile (representing the middle half of the observed values), the difference between Q3 and Q1 is the inter-quartile range.

  • *GCSI is a validated score assessing symptoms severity in patients with gastroparesis, consisting of nine items (symptoms) and three subscales (nausea/vomiting subscale, postprandial fullness/early satiety subscale and the bloating subscale). Each item can be graded from 0 (no symptom) to 5 (maximally severe symptoms). The total GCSI is calculated as the average of all three subscale averages. GCSI value ranges from 0 (no symptoms) to 5 (maximally severe symptomatology). The index evaluates symptoms during the last 14 days. Only patients with GSCI ˃ 2.3 (indicating severe disease) were eligible for enrolment.

  • †PAGI-QOL score—a validated QoL questionnaire measures quality of life outcomes in patients with upper gastrointestinal disorders. It contains 30 items with five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress). A total score is calculated by averaging subscales scores, its value ranges from 0 (perfect QoL) to 5 (worse QoL).

  • ‡GES—is a validated method to demonstrate delayed gastric emptying in patients with gastroparesis. In this trial, all GES were performed according to a standardised method for measuring gastric emptying by scintigraphy; a low-fat, egg-white meal with imaging at 0, 1, 2 and 4 hours after meal ingestion was used for each patient. Only patients with a retention of Tc-99m ˃ 60% at 2 hours and/or≥10% at 4 hours on a standardised sulphur colloid solid phase were eligible for enrolment.

  • §DI—pyloric distensibility is one among several parameters obtained from measurement of pyloric distensibility by using impendance planimetry principle (Endoflip). Values below 10 mm2/mm Hg are thought to demonstrate a pylorospasm. In this trial, not all patients underwent Endoflip measurement as the method was not available when the trial started.

  • DI, Distensibility Index; GCSI, Gastroparesis Cardinal Symptom Index; GES, gastric emptying study; G-POEM, endoscopic pyloromyotomy; PAGI-QOL, Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life.