Efficacy and safety of 0.4 percent sodium hyaluronate for endoscopic submucosal dissection of gastric neoplasms

Table 1 Measurement of usefulness and satisfaction

Completeen blocresection	Additional injection	Usefulness	Satisfaction
Complete	0	Usefulness	Excellent
Complete	1	Usefulness	Good
Complete	≥ 2	Useless	Moderate
Incomplete or not evaluated	-	Useless	Poor

Table 2 Demographic characteristics of the patients at base line

	Sodium hyaluronate	Control	P-value
Age	62.59 ± 9.23	62.44 ± 9.93	0.943
Sex (male/female)	25/12	26/13	0.933
Diagnosis, n (%)
Adenocarcinoma	5 (13.51)	7 (17.95)	0.869
Adenoma	31 (83.78)	31 (79.49)
Atypia	1 (2.7)	1 (2.56)
Size (mm)	14.2 ± 5.47	13.5 ± 4.35	0.293
Location, n (%)
Antrum	23 (62.16)	29 (74.35)	0.465
Angle	3 (8.10)	3 (7.69)
Body	11 (29.72)	7 (17.94)

Table 3 Summary of results n (%)

	Sodium hyaluronate	Control	P-value
ITT
Usefulness rate	30/33 (90.91)	22/36 (61.11)	0.004
Volume of injection	0.03 ± 0.02	0.06 ± 0.03	0.000
Procedural time	23.42 ± 16.76	21.64 ± 16.52	0.658
Steepness			0.228
Steep	26 (78.79)	27 (75.00)
Mild	6 (18.18)	4 (11.11)
Non lifted	1 (3.03)	5 (13.89)
Absence of bleeding	32/33 (96.97)	32/36 (88.89)	0.359
Satisfaction	30/33 (90.91)	22/36 (61.11)	0.002
PP
Usefulness rate	27/29 (93.10)	21/34 (61.76)	0.004
Volume of injection	0.03 ± 0.02	0.06 ± 0.03	0.000
Procedural time	23.79 ± 17.51	19.71 ± 12.65	0.288
Steepness			0.474
Steep	24 (82.76)	26 (76.47)
Mild	4 (13.79)	4 (11.76)
Non lifted	1 (3.45)	4 (11.76)
Absence of bleeding	29/29 (100.00)	30/34 (88.24)	0.118
n (%)	27/29 (93.11)	21/34 (61.77)	0.002

ITT: Intention to treat; PP: Per protocol.

Table 4 Summary of results on location

	Sodium hyaluronate	Control	P-value
ITT
Usefulness rate
Antrum	18/20 (90.00%)	18/27 (66.67%)	0.086
Body/angle	12/13 (92.30%)	6/9 (66.67%)	0.007
Volume of injection
Antrum	0.03 ± 0.02	0.06 ± 0.04	0.003
Body/angle	0.03 ± 0.02	0.05 ± 0.02	0.047
Procedural time
Antrum	19.40 ± 7.46	18.41 ± 11.67	0.741
Body/angle	28.08 ± 25.47	31.33 ± 24.68	0.768
PP
Usefulness rate (%)
Antrum	15/16 (93.75%)	17/26 (65.38%)	0.036
Body/angle	12/13 (92.30%)	3/8 (37.50%)	0.007
Volume of injection
Antrum	0.03 ± 0.02	0.06 ± 0.04	0.011
Body/angle	0.03 ± 0.02	0.05 ± 0.03	0.039
Procedural time
Antrum	19.06 ± 6.78	18.23 ± 11.88	0.800
Body/angle	28.08 ± 25.47	24.50 ± 14.70	0.723

ITT: Intention to treat; PP: Per protocol.