Complete clip closure with staged triple-lumen feeding tube reduces delayed adverse events after duodenal endoscopic submucosal dissection

Table 1 Baseline characteristics of patients grouped by complications, mean ± SD/n (%)

Variable	Complication-free group (n = 156)	Complication group (n = 23)	t/χ2 value	P value
Age (years)	58.63 ± 11.14	57.35 ± 12.14	0.477	0.637
Gender			1.300	0.254
Male	78 (50.00)	15 (62.22)
Female	78 (50.00)	8 (34.78)
BMI (kg/m2)	24.37 ± 3.42	24.06 ± 3.31	0.417	0.680
Hypertension			0.669	0.414
Yes	36 (23.08)	3 (13.04)
No	120 (76.92)	20 (86.96)
Diabetes			0.815	0.316
Yes	21 (13.46)	1 (4.35)
No	135 (86.54)	22 (95.65)
Coronary heart disease			0.062	1.000
Yes	13 (8.33)	1 (4.35)
No	143 (91.67)	22 (95.65)
Admission year			1.063	0.184
2016-2020	18 (11.54)	5 (21.74)
2021-2025	138 (88.46)	18 (78.26)
Lesion location			0.132	0.505
Ampullary area	19 (12.18)	4 (17.39)
Non-ampullary area	137 (87.82)	19 (82.61)
Titanium clip closure status			15.452	< 0.001
Complete	110 (70.51)	6 (26.09)
Incomplete	46 (29.49)	17 (73.91)
Drainage strategy			2.190	0.139
Triple-lumen feeding tube	97 (62.18)	10 (43.48)
Nasogastric tube	59 (37.82)	13 (56.52)

Comparisons between groups for continuous variables were analyzed using the t-test; categorical variables were analyzed using the χ² test. BMI: Body mass index.

Table 2 Univariate and multivariable logistic regression and interaction analyses of the factors associated with delayed adverse events after duodenal endoscopic submucosal dissection

Variable		Model 1		Model 2		Model 3
		OR (95%CI)	P value	aOR (95%CI)	P value	aOR (95%CI)	P value
Age (per 1 SD increase)		0.89 (0.77-1.03)	0.127	0.88 (0.76-1.02)	0.091	0.86 (0.74-1.00)	0.050
BMI (per 1 SD increase)		0.88 (0.76-1.02)	0.093	0.88 (0.76-1.03)	0.107	0.87 (0.75-1.02)	0.080
Gender	Male (reference)	1	< 0.001	1	0.016	1	0.010
	Female	0.53 (0.40-0.72)		0.69 (0.51-0.93)		0.68 (0.50-0.92)
Comorbidity	Without (reference)	1	< 0.001	1	0.084	1	0.130
	With	0.56 (0.41-0.76)		0.75 (0.55-1.04)		0.78 (0.56-1.08)
Admission year	2016-2020	1	< 0.001	1	0.015	1	0.040
	2021-2025	0.47 (0.30-0.73)		0.57 (0.36-0.89)		0.62 (0.39-0.98)
Lesion location	Non-ampullary area (reference)	1	0.061	1	0.005	1	0.005
	Ampullary area	1.52 (0.98-2.35)		1.91 (1.21-3.01)		1.92 (1.22-3.03)
Titanium clip closure status	Incomplete (reference)	1	< 0.001	1	< 0.001	1	< 0.001
	Complete	0.15 (0.11-0.20)		0.16 (0.12-0.22)		0.22 (0.14-0.36)
Drainage strategy	Nasogastric tube (reference)	1	< 0.001	1	0.005	1	0.480
	Triple-lumen feeding tube	0.47 (0.35-0.63)		0.64 (0.46-0.87)		0.83 (0.50-1.39)
Interaction: TCCS × DS						0.49 (0.26-0.93)	0.030

Model 1 Univariable logistic regression. Model 2 Multivariable logistic regression adjusting for prespecified confounders (age, gender, body mass index, comorbidities, year of admission, lesion location, drainage strategy, and titanium clip closure status). Model 3 Multivariable logistic regression including the interaction term between titanium clip closure and drainage strategy in addition to the confounders in model 2. BMI: Body mass index; OR: Odds ratio; aOR: Adjusted odds ratio; CI: Confidence interval; TCCS: Titanium clip closure status; DS: Drainage strategy; “×” indicates interaction.

Table 3 Subgroup χ² analyses of the association between titanium clip closure quality and postoperative complications after duodenal endoscopic submucosal dissection

Stratification variable	Subgroup	Sample Size (n)	Complete closure complication rate (%)	Incomplete closure complication rate (%)	RRR (%)	P value
Age (years)	> 59	85	5.6 (3/54)	19.4 (6/31)	71.3	0.067
	≤ 59	94	4.8 (3/62)	34.4 (11/32)	86.0	< 0.001
Gender	Male	93	8.3 (5/60)	30.3 (10/33)	72.5	0.014
	Female	86	1.8 (1/56)	23.3 (7/30)	92.3	0.002
BMI (kg/m2)	> 24.0	87	5.2 (3/58)	27.6 (8/29)	81.3	0.005
	≤ 24.0	92	5.2 (3/58)	26.5 (9/34)	80.5	0.008
Comorbidity	No	122	6.4 (5/78)	29.5 (13/44)	78.3	< 0.001
	Yes	57	2.6 (1/38)	21.1 (4/19)	87.5	0.038
Lesion location	Non-ampullary area	156	4.0 (4/101)	27.3 (15/55)	85.5	< 0.001
	Ampullary area	23	13.3 (2/15)	25.0 (2/8)	46.7	0.589
Drainage strategy	Nasogastric tube	72	8.9 (4/45)	33.3 (9/27)	73.3	0.013
	Triple-lumen feeding tube	107	2.8 (2/71)	22.2 (8/36)	87.3	0.002
Admission year	2016-2020	23	21.4 (3/14)	22.2 (2/9)	3.6	1.000
	2021-2025	156	2.9 (3/102)	27.8 (15/54)	89.4	< 0.001

RRR (%) = (complication rate in the incomplete closure group - complication rate in the complete closure group)/complication rate in the incomplete closure group. BMI: Body mass index; RRR: Relative risk reduction.

Table 4 Subgroup logistic regression analyses of the association between titanium clip closure quality and postoperative complications after duodenal endoscopic submucosal dissection

Stratified variable	Subgroup	N1	n2	OR (95%CI)	P value
Age (years)	> 59	85	9	0.25 (0.16-0.38)	< 0.001
	≤ 59	94	14	0.10 (0.06-0.15)	< 0.001
Gender	Male	93	15	0.21 (0.14-0.32)	< 0.001
	Female	86	8	0.06 (0.04-0.09)	< 0.001
BMI (kg/m2)	> 24	68	7	0.16 (0.09-0.26)	< 0.001
	≤ 24	111	16	0.15 (0.10-0.22)	< 0.001
Admission year	2016-2020	23	4	0.95 (0.41-2.21)	0.913
	2021-2025	156	18	0.08 (0.06-0.11)	< 0.001
Comorbidity	Without	122	18	0.16 (0.11-0.24)	< 0.001
	With	57	5	0.10 (0.06-0.18)	< 0.001
Lesion location	Non-ampullary area	156	19	0.11 (0.08-0.15)	< 0.001
	Ampullary area	23	4	0.46 (0.20-1.09)	0.077
Drainage strategy	Triple-lumen feeding tube	107	10	0.10 (0.07-0.15)	< 0.001
	Nasogastric tube	72	13	0.20 (0.12-0.31)	< 0.001

¹Total number of patients in each subgroup.

²Number of patients with postoperative complications in each subgroup.

BMI: Body mass index; OR: Odds ratio; CI: Confidence interval.

Table 5 Associations between postoperative drainage methods and inflammatory and nutritional indicators following duodenal endoscopic submucosal dissection

	Model 1				Model 2
	F value	P value	AMD	R2 value	F value	P value	AMD	R2 value
WBC-POD 1	4.303	0.040	-0.120	0.919	6.373	0.013	-0.140	0.927
WBC-POD 3	1.534	0.217	0.460	0.071	1.669	0.198	0.490	0.073
WBC-POD 5	0.426	0.515	-0.240	0.002	0.357	0.551	-0.220	0.004
Neu%-POD 1	19.084	< 0.001	-1.920	0.804	16.507	< 0.001	-1.820	0.811
ALB-POD 1	11.437	< 0.001	0.400	0.959	11.120	< 0.001	0.410	0.960
ALB-POD 3	0.518	0.473	-0.350	0.045	0.151	0.698	-0.190	0.075
ALB-POD 5	0.552	0.459	0.360	0.040	0.260	0.610	0.260	0.059
TP-POD 1	16.221	< 0.001	0.880	0.945	14.228	< 0.001	0.850	0.946
TP-POD 3	0.674	0.413	0.690	0.017	0.141	0.708	0.320	0.044
TP-POD 5	0.350	0.555	0.440	0.002	0.830	0.364	0.700	0.017

Model 1 was adjusted for preoperative baseline values only. Model 2 was adjusted for age, gender, body mass index, comorbidity, year of admission, lesion location, and titanium clip closure status. Due to missing data, neutrophil percentage was available only on postoperative day 1. Adjusted mean difference (the difference in postoperative indicator means after adjustment for age, gender, body mass index, comorbidity, lesion location, and titanium clip closure status). F value calculated analysis of covariance test statistic. R² value coefficient of determination. WBC: White blood cell; TP: Total protein; Neu%: Neutrophil percentage; ALB: Albumin; POD: Postoperative day.