Effect of polyglycolic acid sheet plus esophageal stent placement in preventing esophageal stricture after endoscopic submucosal dissection in patients with early-stage esophageal cancer: A randomized, controlled trial

Table 1 Baseline characteristics n (%)

Parameter	PGA + stent group (n = 34)	Stent group (n = 32)	P value
Patients characteristic
Age (yr)	62.74 ± 8.38	59.91 ± 8.80	0.186
Gender (Male/Female)	22/12	18/14	0.482
Tumor lesion feature
Location			0.145
Upper third	0 (0)	0 (0)
Middle third	12 (35)	17 (53)
Lower third	22 (65)	15 (47)
Tissue depth			0.331
M1	20 (59)	15 (47)
M2	14 (41)	17 (53)
Longitudinal length (cm)	5.97 ± 2.68	6.06 ± 2.12	0.878
Circumferential range			0.684
3/4	12 (35)	14 (44)
4/5	8 (24)	8 (25)
1/1	14 (41)	10 (31)

Data are presented as mean ± SD or count (with or without percentage). Comparison was performed by t-test or Chi-square test. P < 0.05 was considered significant. PGA: Polyglycolic acid.

Table 2 Comparison of esophageal stricture features in polyglycolic acid + stent and stent groups

Parameter	PGA + stent group (n = 7)	Stent group (n = 15)	P value
Length (cm)	0.97 + 0.59	1.47 + 0.59	0.080
Diameter (cm)	0.37 + 0.17	0.51 + 0.14	0.061
Location (distance from the incisors, cm)	31.71 + 3.20	29.07 + 5.20	0.232
Balloon dilatation times	4 (2-5)	6 (1-14)	0.007

Data are presented as mean ± SD or median (range). Comparison was performed by t-test or Wilcoxon rank sum test. P < 0.05 was considered significant. PGA: Polyglycolic acid.

Table 3 Comparison of tumor lesion features in patients with esophageal stricture n (%)

Parameter	PGA + stent group (n = 7)	Stent group (n = 15)	P value
Location			0.899
Upper third	0 (0)	0 (0)
Middle third	4 (57)	9 (60)
Lower third	3 (43)	6 (40)
Tissue depth			0.823
M1	2 (29)	5 (33)
M2	5 (71)	10 (67)
Longitudinal length (cm)	7.71 + 3.50	6.60 + 2.10	0.360
Circumferential range			0.181
3/4	0 (0)	4 (27)
4/5	1 (14)	4 (27)
1/1	6 (86)	7 (47)

Data are presented as mean ± SD or count (percentage). Comparison was determined by t-test or Chi-square test. P < 0.05 was considered significant. PGA: Polyglycolic acid.

Table 4 Logistic analysis of factors affecting esophageal stricture occurrence

Parameter	Univariate logistic regression				Multivariate logistic regression
	P value	OR	95%CI		P value	OR	95%CI
			Lower	Higher			Lower	Higher
PGA + stent (vs stent alone)	0.027	0.294	0.099	0.868	0.026	0.197	0.047	0.820
Age ≥ 62 yr	0.298	1.733	0.615	4.887	-	-	-	-
Location - middle third (vs lower third)	0.083	2.528	0.886	7.214	0.034	5.148	1.135	23.344
Longitudinal length ≥ 6 cm	0.059	2.779	0.963	8.019	0.092	3.826	0.801	18.270
Circumferential range = 1/1 (vs others)	0.008	4.333	1.457	12.888	0.028	5.113	1.194	21.892
Tissue depth M2 (vs M1)	0.017	3.750	1.264	11.123	0.069	3.284	0.912	11.822

Data are presented as P-value, OR (odds ratio), and 95%CI. Factors affecting esophageal stricture occurrence were determined by univariate logistic regression analysis, while all factors with a P-value less than 0.1 were further detected by multivariate logistic regression analysis. P-value < 0.05 was considered significant. PGA: Polyglycolic acid.