Effects of premedication with Pronase for endoscopic ultrasound of the stomach: A randomized controlled trial

Table 1 Eligibility and exclusion criteria for this study

Eligibility criteria
1	Patients who required an EUS examination because of gastric diseases
2	Patients aged 18-70 yr
Exclusion criteria
1	Patients with contraindications to endoscopy
2	Patients allergic to the pharmaceutical ingredients
3	Patients with gastric bleeding or suspected gastric bleeding
4	Patients with blood coagulation dysfunction
5	Patients with severe psychological diseases such as depression, anxiety, hypochondria and hysteria
6	Patients with severe cardiac dysfunction (NYHA cardiac function classification ≥ class III)
7	Patients with abnormal hepatic function (serum ALT and AST levels of ≥ 4 times the upper normal limit)
8	Patients with renal dysfunction (serum Cr level of ≥ 2 times the upper normal limit)
9	Patients with moderate to severe ventilatory dysfunction
10	Diabetic patients with unsatisfactory glycemic control
11	Hypertensive patients with unsatisfactory blood pressure control
12	Pregnant women or women who are breastfeeding

ALT: Alanine aminotransferase; AST: Aspartate transaminase; Cr: Creatinine; EUS: Endoscopic ultrasonography; NYHA: New York Heart Association.

Table 2 Scoring of the gastric cavity obscurity grade

Score	Number of high-echo spots
0	No or few
1	Low
2	Moderate
3	High

Table 3 Scoring of the gastric wall surface in endoscopic ultrasonography imaging

Score	Artifacts
0	Notable, affecting the diagnosis
1	Moderate
2	Negligible
3	None, clear wall interface

Table 4 Demographic characteristics of enrolled patients

	Pronase group	Placebo group	Value	P value
Number of patients	63	62
Age, mean ± SD	55.78 ± 12.37	53.47 ± 13.41	t = 1.001	0.319
Sex
Male	22	19	χ2 = 0.259	0.611
Female	41	43
Location
Fundus	14	9	χ2 = 1.264	0.532
Corpus	26	29
Antrum	23	24
Methods
Radial EUS	48	43	χ2 = 0.737	0.391
Linear-array EUS	15	19

EUS: Endoscopic ultrasonography

Table 5 Endoscopic ultrasonography obscurity scores for the gastric cavity and mucosal surface

	Pronase group	Placebo group	Value	P value
Gastric cavity obscurity scores during EUS
3	14	8	Z = -3.428	0.001
2	35	21
1	11	20
0	3	13
Gastric mucosal surface obscurity scores during EUS
3	11	7	Z = -3.861	0.000
2	37	10
1	6	36
0	9	9

EUS: Endoscopic ultrasonography.

Table 6 Mean endoscopic ultrasonography obscurity scores for the gastric cavity and mucosal surface

	Pronase group	Placebo group	Value	P value
Mean gastric cavity obscurity scores	1.0476 ± 0.77	1.6129 ± 0.96	t = -3.617	0.000
Mean gastric mucosal surface obscurity scores	1.2063 ± 0.90	1.7581 ± 0.84	t = -3.534	0.001
Duration of EUS, mean ± SD	11.60 ± 3.32	13.13 ± 3.81	t = -2.387	0.018
Volume of saline, mean ± SD	417.94 ± 121.38	467.42 ± 104.52	t = -2.441	0.016