Usefulness of the clip-flap method of endoscopic submucosal dissection: A randomized controlled trial

doi:10.3748/wjg.v24.i35.4077

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World Journal of Gastroenterology

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1007-9327

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Randomized Clinical Trial

World J Gastroenterol. Sep 21, 2018; 24(35): 4077-4085
Published online Sep 21, 2018. doi: 10.3748/wjg.v24.i35.4077

Table 1 Characteristics of patients scheduled to undergo endoscopic submucosal dissection between those with or without endoclip

	Total	Conventional group	Clip-flap group	P value
Number (n)	104	55	49
Age (yr)	70.1 ± 8.3	69.0 ± 9.5	71.2 ± 6.5	0.17
Sex (male : female)	80:24	42:13	38:11	0.89
Body weight (kg)	59.0 ± 11.2	58.0 ± 11.0	60.2 ± 11.5	0.34
BMI (kg/m²)	22.2 ± 3.1	21.7 ± 2.9	22.8 ± 3.3	0.08
Drugs, n (%)
Anticoagulants	19 (18.3)	11(20.0)	8 (16.3)	0.63
Antihypertensive dugs	56 (53.8)	25 (45.5)	31 (63.3)	0.07
Oral hypoglycemics	16 (15.4)	8 (14.5)	8 (16.3)	0.80
Cholesterol-lowering agents	25 (24.0)	13 (23.6)	12 (24.5)	0.91
H. pylori infection (positive)	36 (34.6)	16 (29.1)	20 (40.8)	0.21
Hemodialysis, n (%)	0 (0)	0 (0)	0 (0)	-
Kyoto classification of gastric mucosa
Atrophy (A0:A1:A2)	3:7:94	2:4:49	1:3:45	0.86
Intestinal metaplasia (IM0:IM1:IM2)	8:36:60	5:15:35	3:21:25	0.24
Diffuse redness (DR0:DR1 :DR2)	47:24:33	26:13:16	21:11:17	0.83
Tumor
Histological diagnosis (adenoma/cancer)	9/95	6/49	3/46	0.39
Differentiation (tub1 + tub2/por + sig)	92/3	48/1	44/2	0.52
Depth (m/sm)	82/13	42/7	40/6	0.86
Location (upper third/middle/lower)	10/37/57	7/20/28	3/17/29	0.47
Major axis of tumor (mm)	18.5 ± 13.4	17.5 ± 11.8	19.7 ± 15.1	0.39
ESD
Procedure time (min)	72.6 ± 49.5	70.8 ± 46.2	74.7 ± 53.3	0.69
Area of resected specimen (mm²)	962 1 ± 896.2	884.6 ± 792.1	1006.4 ± 1004.8	0.49
En bloc resection rate (n, %)	104 (100)	55 (100)	49 (100)	-
Curative endoscopic resection rate (n, %)	94 (90.4)	50 (90.9)	44 (89.8)	0.85
Coagulation of vessels at 2^nd look (n, %)	28 (26.9)	16 (29.6)	12 (25.0)	0.60
Delayed bleeding (n, %)	4 (3.8)	3 (5.5)	1 (2.0)	0.37
Perforation (n, %)	2 (1.9)	1 (1.8)	1 (2.0)	0.93
Operator
Procedure times (< 50 cases)	83	43	40	0.66

A0: No atrophic pattern; A1: Atrophic patterns with a margin between the non-atrophic fundic mucosa and atrophic mucosa located in the lesser curvature of the stomach; A2: Atrophic patterns; whose margin does not cross the lesser curvature; BMI: Body mass index; DR0: No diffuse erythema; DR1: Mild diffuse erythema; DR2: Severe diffuse erythema; IM0: No intestinal metaplasia; IM1: Intestinal metaplasia within antrum; IM2: Intestinal metaplasia up to corpus; lower: Lower third of the stomach; m: mucosal layer; middle: Middle third of the stomach; por: Poorly differentiated adenocarcinoma; sig: Signet ring cell carcinoma; sm: Submucosal layer; tub1: Well differentiated adenocarcinoma; tub2: Moderately differentiated adenocarcinoma; upper: Upper third of the stomach; ESD: Endoscopic submucosal dissection; H. pylori: Helicobacter pylori.

Table 2 Efficacy by procedure time of endoscopic submucosal dissection for gastric tumors within inclusion criteria

		Conventional group(n = 50)	Clip-flap group(n = 44)	P value
Procedure time (min)		67.3 ± 44.9	67.6 ± 48.4	0.98
H. pylori infection	Positive	64.1 ± 27.8 (n = 15)	65.6 ± 53.1 (n = 19)	0.92
	Negative	68.6 ± 50.7 (n = 35)	69.1 ± 45.5 (n = 25)	0.98
Kyoto classification of gastric mucosa
Atrophy	A2	68.7 ± 45.2 (n = 44)	70.3 ± 49.7 (n = 40)	0.87
	A0 + 1	57.2 ± 44.8 (n = 6)	40.3 ± 17.6 (n = 4)	0.50
Intestinal metaplasia	IM2	71.6 ± 45.8 (n = 31)	65.2 ± 45.2 (n = 22)	0.62
	IM0 + IM1	60.2 ± 43.6 (n = 19)	70.0 ± 52.3 (n = 22)	0.53
Tumor
Histological diagnosis	Adenoma	36.5 ± 11.1 (n = 6)	58.0 ± 40.2 (n = 3)	0.24
	Cancer	71.5 ± 46.1 (n = 44)	68.3 ± 49.3 (n = 41)	0.76
Differentiation	tub1 + tub2	71.1 ± 46.6 (n = 43)	69.0 ± 49.7 (n = 40)	0.85
	Por + sig	90 (n = 1)	40 (n = 1)	-
Depth	m	71.4 ± 47.2 (n = 42)	62.7 ± 40.1 (n = 38)	0.38
	sm	74.0 ± 1.4 (n = 2)	139.6 ± 97.1 (n = 3)	0.43
Location	Upper	119.8 ± 60.9 (n=6)	158.5 ± 101.1 (n=2)	0.52
	Middle	74.8 ± 37.3 (n = 19)	91.4 ± 52.1 (n = 14)	0.29
	Lower	49.0 ± 34.7 (n = 25)	49.2 ± 28.0 (n = 28)	0.98
Major axis of tumor (mm)	< 10	50.0 ± 35.9 (n = 24)	46.6 ± 31.0 (n = 20)	0.74
	10 <, < 20	72.3 ± 46.2 (n = 16)	59.8 ± 23.7 (n = 14)	0.37
	20 <	100.8 ± 44.9 (n = 10)	120.5 ± 64.5 (n = 10)	0.44
ESD
Area of specimen (mm²)	< 500	33.8 ± 14.0 (n = 22)	53.2 ± 51.7 (n = 15)	0.17
	500 <, < 1000	72.6 ± 38.4 (n = 16)	71.1 ± 29.3 (n = 23)	0.89
	1000 <	86.0 ± 32.1 (n = 12)	138.5 ± 79.3 (n = 9)	0.06
Coagulation of vessels at 2^nd look	Done	69.5 ± 38.4 (n = 13)	67.4 ± 28.8 (n = 12)	0.89
	No	66.5 ± 47.4 (n = 37)	67.6 ± 52.6 (n = 35)	0.92
Delayed bleeding (n, %)		105.7 ± 23.7 (n = 3)	80 (n = 1)	-
Perforation (n, %)		71 (n = 1)	234 (n = 1)	-
Operator
Procedure times	< 50 times	61.1 ± 37.1 (n = 39)	58.8 ± 32.1 (n = 36)	0.78
	> 50 times	89.3 ± 62.9 (n = 11)	107.0 ± 83.9 (n = 8)	0.60

Table 3 Univariate analysis of parameters for delayed procedure time of endoscopic submucosal dissection

	Parameters	Conventional group			Clip-flap group
	Parameters	Odds ratio	95%CI	P value	Odds ratio	95%CI	P value
Age (yr)	> 70	0.67	0.22-2.10	0.49	0.79	0.22-2.86	0.72
Sex	Male	2.70	0.63-11.55	0.18	-	-	-
H. pylori infection	Positive	1.31	0.39-4.44	0.66	0.69	0.20-2.43	0.57
Kyoto classification of gastric mucosa
Atrophy (vs A0 + A1)	A2	1.52	0.25-9.19.57	0.65	-	-	-
Intestinal metaplasia (vs IM0 + IM1)	IM2	2.03	0.61-6.72	0.25	1.00	0.29-3.42	1.00
Tumor
Depth (vs m)	sm	-	-	-	3.85	0.31-46.49	0.29
Location (vs Lower)	Upper/middle	10.12	2.42-42.41	0.02	4.75	1.41-16.05	< 0.01
Major axis of tumor (mm) (vs < 10)	10 <, < 20	3.00	0.78-11.54	0.11	3.15	0.61-16.29	0.17
	20 <	7.00	1.36-36.01	0.02	22.67	3.14-163.63	< 0.01
Ulceration	UL+	1.42	0.18-10.99	0.74	1.80	0.104-30.89	0.69
ESD
Area of specimen (mm²) (vs < 500)	500 <	3.29	0.28-39.14	0.35	-	-	-
Operator
Procedure experience	< 50 times	0.32	0.08-1.29	0.11	0.26	0.05-1.30	0.10

Citation: Ban H, Sugimoto M, Otsuka T, Murata M, Nakata T, Hasegawa H, Inatomi O, Bamba S, Andoh A. Usefulness of the clip-flap method of endoscopic submucosal dissection: A randomized controlled trial. World J Gastroenterol 2018; 24(35): 4077-4085
URL: https://www.wjgnet.com/1007-9327/full/v24/i35/4077.htm
DOI: https://dx.doi.org/10.3748/wjg.v24.i35.4077