Table 2 Post-ESD ulcer healing and clinical symptoms at 4 weeks and 8 weeks after ESD.

From: Comparison of rebamipide and tegoprazan combination therapy and tegoprazan monotherapy for ESD induced gastric ulcers a randomized multicenter study

Variables

Modified ITT analysis

Per-protocol analysis

Combination therapy (n = 64)

Tegoprazan monotherapy

(n = 68)

P value

Combination therapy (n = 56)

Tegoprazan monotherapy

(n = 65)

P value

Long diameter of ulcer (mean ± SD) (mm)

 Initial

35.20 ± 9.79

32.2 ± 8.91

0.06

35.1 ± 10.10

32.02 ± 8.79

0.08

 4 weeks after ESD

7.23 ± 5.14

8.0 ± 5.31

0.40

7.46 ± 5.36

7.91 ± 5.37

0.65

 8 weeks after ESD*

0.92 ± 2.74

0.70 ± 1.87

0.61

0.91 ± 2.75

0.74 ± 1.91

0.70

Area of ulcer (mean ± SD) (mm2)

 Initial

1064.88 ± 549.23

889.74 ± 449.93

0.05

1064 ± 572.83

889.80 ± 452.59

0.06

 4 weeks after ESD

44.59 ± 70.60

51.47 ± 68.64

0.57

47.25 ± 74.82

51.45 ± 69.86

0.75

 8 weeks after ESD*

3.18 ± 10.32

2.44 ± 9.70

0.68

3.36 ± 10.88

2.56 ± 9.92

0.68

Difference of ulcer area at week 4

1020.28 ± 505.39

838.26 ± 438.83

0.03

1017.11 ± 525.42

838.35 ± 441.21

0.04

Difference of ulcer area at week 8*

1071.56 ± 534.66

886.36 ± 433.99

0.04

1073.32 ± 558.20

886.26 ± 436.12

0.05

Ulcer healing rate, (mean ± SD)

 Healing rate at week 4

96.37 ± 3.80

93.58 ± 9.28

0.02

96.19 ± 3.98

93.62 ± 9.45

0.05

 Healing rate at week 8*

99.78 ± 0.85

99.69 ± 1.30

0.64

99.77 ± 0.90

99.67 ± 1.33

0.65

Ulcer stage at week 4, n (%)

  

0.30

  

0.31

 Active stage

0 (0%)

3 (4.4%)

 

0 (0%)

3 (4.7%)

 

 Healing stage

57 (89.1%)

56 (82.4%)

 

50 (89.3%)

53 (81.5%)

 

 Scar stage

7 (10.9%)

9 (13.2%)

 

6 (10.7%)

9 (13.8%)

 

Ulcer stage at week 8*, n (%)

  

0.79

  

0.78

 Healing stage

7 (11.5%)

9 (14.1%)

 

6 (11.3%)

9 (14.8%)

 

 Scar stage

54 (88.5%)

55 (85.9%)

 

47 (88.7%)

52 (85.2%)

 

Spontaneous bleeding at week 4, n (%)

4 (6.2%)

25 (36.8%)

< 0.001

2 (3.6%)

24 (36.9%)

< 0.001

Spontaneous bleeding at week 8, n (%)

2 (3.3%)

2 (3.1%)

> 0.999

2 (3.8%)

2 (3.3%)

> 0.999

KGSRS score (mean ± SD)

 KGSRS score at week 4

0.86 ± 1.64

1.00 ± 1.33

0.59

0.96 ± 1.72

1.00 ± 1.32

0.90

 KGSRS score at week 8

0.59 ± 1.17

0.78 ± 1.20

0.62

0.66 ± 1.24

0.79 ± 1.22

0.57

  1. ESD, endoscopic submucosal dissection; ITT, intention to treat; KGSRS, Korean form of the Gastrointestinal Symptom Rating Scale; SD, standard deviation.
  2. *Post-ESD ulcer healing at 8 weeks was analyzed, excluding 7 patients who did not perform follow-up endoscopy at 8 weeks after ESD (3 patients in combination therapy, 4 patients in tegoprazan monotherapy).
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