A prospective, open-labeled, and randomized trial for assessing safety and clinical utility of gastric biopsies during emergency gastroscopy for patients with bleeding gastric ulcers

Figures & data

Table 1. Baseline Characteristics of the Patients.

Patient Characteristics	No biopsy group	Biopsy group	p value
	(N = 75)	(N = 75)
Age—yr	56.8 ± 19.3	59.1 ± 17.7	.382
Male sex—no.(%)	62 (82.7)	63 (84.0)	.713
Coexisting disease—no.(%)
Ischemic heart disease	10 (13.3)	11 (14.7)	.609
Renal disease	16 (21.3)	14 (18.7)	.167
Liver cirrhosis	8 (10.7)	5 (6.7)	.507
Postoperative gastric cancer	8 (10.7)	5 (6.7)	.332
Medication history—no.(%)
NSAIDs use	8 (10.7)	9 (12.0)	.911
Asprine use	10 (13.3)	13 (17.3)	.847
Clopidogrel use	8 (10.7)	10 (13.3)	.903
Warfarin or direct oral nticoagulant use	4 (5.3)	3 (4.0)	.497
Indication—no.(%)
Melaena	72 (96.0)	74 (98.7)	.507
Hematemesis	17 (22.7)	15 (20.0)	.446
Syncope	9 (12.0)	6 (8.0)	.383
Glasgow-Blatchford score category -no. (%)			.614
12–14	53 (70.7)	44 (58.7)
15–23	22 (29.3)	31 (41.3)
Glasgow–Blatchford score	12.4 ± 2.8	14.50 ± 2.8
Hemoglobin level on admission—g/L	79	89	.140
Systolic blood pressure—mm Hg	120.9	117.0	.374
Heart rate >100 beats/min—no. (%)	36 (48.0)	37 (49.3)	.976
Urea—	16.1	13.6	.087
Creatine—	196.3	191.5	.051
Albumin—	31.6	34.8	.076
Coagulation
APTT	26.4	25.0	.185
PT	13.3	12.5	.152
INR	1.3	1.1	.177

Figure 1. Flow diagram for the patient selection progress.

Table 2. Differences between ulcers in patients subjected or not subjected to a biopsy at initial gastroscopy.

Finding	No biopsy group	biopsy group	p
	(N = 75)	(N = 75)
Ulcer location—no.(%)			.054
Body	10 (13.3)	19 (25.3)
Antrum	22 (29.3)	24 (32.0)
Incisura	16 (21.3)	17 (22.7)
Fundus	19 (25.3)	10 (13.3)
Anastomotic stoma	8 (10.7)	5 (6.7)
Ulcer morphology–no.(%)			.057
Cratered	36 (48.0)	38 (50.7)
Superficial	15 (20.0)	24 (32.0)
Linear	12 (16.0)	6 (8.0)
Other	12 (16.0)	7 (9.3)
Forrest classification—no.(%)			.441
Ia	4 (5.3)	4 (5.3)
Ib	8 (10.7)	8 (10.7)
IIa	13 (17.3)	14 (18.7)
IIb	11 (14.7)	10 (13.3)
IIc	10 (13.3)	8 (10.7)
III	29 (38.7)	31 (41.3)
Size [median (IQR)] (mm)	12.7 ± 2.9	14.5 ± 2.8	.778
Operating time (min, X ± s)	21.9 ± 3.1	21.2 ± 3.7	.102
Methods of endoscopic hemostasis-no.(%)			.453
Injection therapy	39 (52.0)	41 (54.7)
Thermal coagulation	5 (6.7)	6 (8.0)
Mechanical therapy	17 (22.7)	15 (20.0)
Combination therapy	13 (17.3)	11 (14.7)
Injection and Mechanical	8 (61.5)	7 (63.6)
Injection and Thermal	1 (7.7)	1 (9.1)
Mechanical and Thermal	2 (15.4)	2 (18.2)
Injection/Mechanical/Thermal	2 (15.4)	1 (9.1)

Table 3. Primary and secondary endpoints.

Outcomes of patients	No biopsy group	Biopsy group	p
	(N = 75)	(N = 75)
Primary endpoints
Re-bleeding from any cause within 60 days	8 (10.7)	7 (9.3)	.077
Nosocomial bleeding	5 (62.5)	4 (57.1)
Further bleeding	3 (37.5)	3 (42.9)
Secondary endpoints
Need for repeating endotherapeutic intervention	13 (17.3)	5 (6.7)	.034
Average units of blood transfused	0.6 ± 0.1	0.5 ± 0.2	.295
In-hospital mortality rate	0	0	–
Length of stay in the hospital	10.5 ± 1.9	11.7 ± 2.4	.700
Hospitalization costs	29082.4	24047.2	.016
Conversion to laparotomy–no. (%)	2 (2.7)	1 (1.3)	.340
Pathological findings –no. (%)			.019
Benign	39 (52.0)	61 (81.3)
Malignant	3 (4.0)	14 (18.7)
Helicobacter pylori infection-no. (%)	32 (42.7)	65 (86.7)	.021

Table 4. Univariate analyses for the risk factors linked to re-bleeding.

Measure		No re-bleeding	re-bleeding	p-value
		(N = 135)	(N = 15)
Biopsy-no. (%)	yes	65 (48.1)	10 (66.7)	.609
	no	70 (51.9)	5 (33.3)
Coexisting disease —no.(%)
Ischemic heart disease		14 (10.4)	7 (46.7)	.000
Renal disease		25 (18.5)	5 (33.3)	.000
Liver cirrhosis		8 (5.9)	5 (33.3)	.507
Cancer		7 (5.2)	6 (53.3)	.799
Medication history—no. (%)
NSAID use		5 (3.7)	12 (80.0)	.000
Aspirin use		13 (9.6)	5 (33.3)	.045
Clopidogrel use		13 (9.6)	10 (66.7)	.977
Warfarin or direct oral anti-coagulant use		2 (1.5)	5 (33.3)	.050
Glasgow–Blatchford score
12 to 14		12.9 ± 0.8	13.6 ± 0.8	.352
15 to 23		16.9 ± 1.3	18.8 ± 2.1	.478
Hemoglobin level on admission—g/L		79.7 ± 23.9	74.3 ± 29.4	.349
Platelet level on admission—×10^9/L		279.7 ± 110.9	239.3 ± 120.5	.104
Systolic blood pressure—mmHg		114.2 ± 10.5	109.1 ± 9.5	.875
Helicobacter pylori infection—no. (%)		90 (66.7)	7 (46.7)	.000
Urea—		5.7 ± 0.3	15.4 ± 1. 6	.000
Creatine—		185.0 ± 21.2	80.4 ± 25.1	.000
Albumin—		32.0 ± 6.2	36.1 ± 6.1	.000
Coagulation
APTT		24.9 ± 3.0	25.6 ± 4.0	.789
PT		11.9 ± 1.2	12.8 ± 1.8	.530
Ulcer location—no. (%)				.652
Body		29 (21.5)	2 (13.3)
Antrum		38 (28.1)	6 (40.0)
Incisura		30 (22.2)	3 (20.0)
Fundus		26 (19.3)	3 (20.0)
Anastomotic stoma		12 (8.9)	1 (6.7)
Forrest classification—no. (%)				.001
Ia		6 (4.4)	2 (13.3)
Ib		9 (6.7)	7 (46.7)
IIa		25 (18.5)	2 (13.3)
IIb		18 (13.3)	3 (20.0)
IIc		17 (12.6)	1 (6.7)
III		60 (44.4)	0

Table 5. Multivariate analysis.

Factors	Β	S.E.	Wals	p	OR	95% CI
Ischemic heart disease	–9.288E–01	.254	13.334	.000	0.395	.240	.650
Renal disease	–1.974	.999	10.822	.002	1.740	.773	1.590
NSAID use	1.039	.216	23.194	.000	2.828	1.852	4.317
Warfarin or direct oral anticoagulant use	2.481	.108	15.377	.000	11.953	3.494	39.760
Helicobacter pylori infection	–4.342E	1.331	10.648	.407	.013	.001	.177
Creatine level ≥ 265 mmol/L	2.231	.464	23.164	.000	9.308	3.752	23.088
Urea level ≥ 12mmol/L	.028	.010	7.266	.007	1.028	1.008	1.050
ALB level ≤ 30 g/L	40.522	13.757	8.677	.003	1650.349	–	–
Forrest classification	–0.281	0.205	2.982	.087	2.098	0.908	4.980

Figure 2. Kaplan–Meier curve showing 60-day without re-bleeding for patients in the biopsy and no biopsy groups.