Therapeutic Outcomes and Risk Factors for Complications of Endoscopic Papillectomy: A Retrospective Analysis of a Single-Center Study

Figures & data

Figure 1 An example of EP procedure. (A) Observe the papillary lesion; (B) Lift the lesion by submucosal injection (when necessary); (C and D) En bloc resection of the lesion with endoloop; (E and F) Cannulate the bile duct, and retain the guidewire in the bile duct; (G) Hemostasis with metal clips; (H) Implant the biliary stent; (I) Spray hemostatic sealant (fibrin glue) on the closed wound.

Table 1 Characteristics of Patients in the Overall Study Population

Characteristics of Patients
Age (mean±SD, range, years)	58.4±12.1 (26–88)
Sex (Female n, %)	36 (47.5)
Chief complaint (n, %)
Abdominal pain or distension	25 (32.9)
Jaundice	8 (10.5)
Cholangitis	6 (7.9)
Pancreatitis	5 (6.6)
Fever and fatigue	2 (2.6)
Incidental finding	30 (39.5)
Characteristics of disease
Tumor size (mean±SD, range, cm^2)	4.48±5.74 (0.6–28)
Bile duct dilatation (n/total, %)	12/32 (37.5)
Pancreatic duct dilatation (n/total, %)	7/39 (18)
Pathologic type (n, %)
Non-IN	35 (46.1)
LIN	11 (14.5)
HIN	28 (36.8)
NT	2 (2.63)
Interventions
Submucosal injection (n, %)	13 (17.1)
Type of resection (n, %)
En bloc	61 (80.3)
Piecemeal	15 (19.7)
Hemostasis (n, %)
Metal clips	63 (82.9)
Hemostatic sealant	22 (29)
Epinephrine	17 (22.4)
Stent implantation (n, %)
Pancreatic stent	30 (39.5)
Biliary stent	23 (30.3)
Double stent	15 (19.7)
Non stent	8 (10.5)
Pancreatography (n, %)	39 (51.3)
Endoscopic sphincterotomy (n, %)	24 (31.6)

Abbreviations: non-IN, non-intraepithelial neoplasia; HIN, high-grade intraepithelial neoplasia; LIN, low-grade intraepithelial neoplasia; NT, neuroendocrine tumor.

Table 2 Post-EP Complications in 76 Patients

Complications	Total (n, % of Total Procedure)	Severity (n, % of Complications)
		Mild	Moderate	Severe
Pancreatitis	19 (25)	13 (68.4)	5(26.3)	1 (5.3)
Bleeding	14 (18.4)	6 (42.9)	3 (21.4)	5 (35.7)
Perforation	3 (3.9)	0 (0)	1 (33.3)	2 (66.7)
Cholangitis	1 (1.3)	0 (0)	1 (100)	0 (0)
MODS	5 (6.6)	0 (0)	0 (0)	5 (100)
Overall complications	28 (36.8)	17 (60.7)	6 (21.4)	5 (17.9)

Abbreviation: MODS, multiple organ dysfunction syndrome.

Table 3 Univariate Analysis of Post-EP Complication Related Risk Factors

Variable	n in Complication Cases /Total n of Occurrence	OR	95% CI	P
Characteristics of patients
Age (mean, years)	58.75		−6.26–5.26	0.863
Sex (Female)	13/36	0.94	0.37–2.34	>0.999
Indication of EP
Abdominal pain or distension	9/25	0.95	0.36–2.57	>0.999
Jaundice	3/8	1.03	0.26–4.48	>0.999
Cholangitis	1/6	0.32	0.03–2.64	0.404
Pancreatitis	1/5	0.41	0.03–2.73	0.646
Fever and fatigue	2/2	Infinity	0.81 – Infinity	0.133
Incidental finding	12/30	1.25	0.47–3.20	0.808
Characteristics of disease
Tumor size (mean, cm^2)	2.313		−0.90–4.64	0.181
Bile duct dilatation	5/12	0.71	0.16–2.70	0.726
Pancreatic duct dilatation	3/7	1.14	0.39–2.53	>0.999
Pathologic type
Non-IN	7/35	0.24	0.09–0.65	0.008**
LIN	3/11	0.60	0.16–2.33	0.737
HIN	18/28	6.84	2.41–20.49	0.0002***
NT	0/2	0.00	0.00–3.70	0.528
Interventions
Submucosal injection	3/13	0.46	0.13–1.63	0.351
Type of resection
En bloc	23/61	1.21	0.36–3.58	>0.999
Piecemeal
Hemostasis
Metal clips	23/63	0.90	0.27–2.94	>0.999
Hemostatic sealant	8/22	0.97	0.33–2.82	>0.999
Epinephrine	7/17	1.27	0.45–3.79	0.777
Stent implantation
Pancreatic stent	15/30	2.54	0.99–6.98	0.088
Biliary stent	4/23	0.25	0.09–0.88	0.0225*
Double stent	7/15	1.67	0.56–4.77	0.388
Non stent	2/8	0.54	0.11–2.41	0.703
Pancreatography	15/39	1.15	0.47–2.93	0.815

Notes: * P ≤ 0.05, ** P ≤ 0.01, ***P ≤ 0.001.

Abbreviations: non-IN, non-intraepithelial neoplasia; HIN, high-grade intraepithelial neoplasia; LIN, low-grade intraepithelial neoplasia; NT, neuroendocrine tumor; OR, odds ratio; CI, confidence interval.

Table 4 Univariate Analysis of Post-EP Pancreatitis Related Risk Factors

Variable	n in Pancreatitis Cases /Total n of Occurrence	OR	95% CI	P
Characteristics of patients
Age (mean, years)	54.32		−0.80–11.78	0.086
Sex (Female)	7/36	0.56	0.21–1.53	0.427
Indication of EP
Abdominal pain or distension	7/25	1.26	0.46–3.56	0.779
Jaundice	1/8	0.40	0.03–2.59	0.671
Cholangitis	1/6	0.58	0.05–4.94	>0.999
Pancreatitis	1/5	0.74	0.06–5.04	>0.999
Fever and fatigue	0/2	0.00	0.00–6.53	>0.999
Incidental finding	9/30	1.54	0.54–4.28	0.431
Characteristics of disease
Tumor size (mean, cm^2)	3.84		−3.59–5.20	0.713
Bile duct dilatation	2/12	0.30	0.06–1.56	0.248
Pancreatic duct dilatation	1/7	0.43	0.03–3.79	0.653
Pathologic type
Non-IN	3/35	0.15	0.04–0.52	0.003**
LIN	3/11	1.15	0.30–4.71	>0.999
HIN	13/28	6.07	2.06–20.13	0.002**
NT	0/2	0.00	0.00–6.53	>0.999
Interventions
Submucosal injection	3/13	0.88	0.24–3.24	>0.999
Type of resection
En bloc	16/61	1.42	0.34–5.19	0.748
Piecemeal
Hemostasis
Metal clips	15/63	0.70	0.21–2.31	0.726
Hemostatic sealant	7/22	1.63	0.58–4.79	0.395
Epinephrine	6/17	1.60	0.69–3.36	0.342
Stent implantation
Pancreatic stent	12/30	3.71	1.33–10.26	0.028*
Biliary stent	4/23	0.53	0.17–1.73	0.395
Double stent	3/15	0.70	0.19–2.91	0.748
Non stent	0/8	0.00	0.00–1.37	0.189
Pancreatography	10/39	1.07	0.39–3.03	>0.999

Notes: * P ≤ 0.05, ** P ≤ 0.01.

Abbreviations: non-IN, non-intraepithelial neoplasia; HIN, high-grade intraepithelial neoplasia; LIN, low-grade intraepithelial neoplasia; NT, neuroendocrine tumor; OR, odds ratio; CI, confidence interval.

Table 5 Univariate Analysis of Post-EP Bleeding Related Risk Factors

Variable	n in Bleeding Cases /Total n of Occurrence	OR	95% CI	P
Characteristics of patients
Age (mean, years)	62.79		−12.40–1.73	0.137
Sex (Female)	7/36	1.14	0.38–3.45	>0.999
Indication of EP
Abdominal pain or distension	5/25	1.17	0.38–3.67	>0.999
Jaundice	2/8	1.56	0.29–7.66	0.635
Cholangitis	0/6	0.00	0.00–2.39	0.586
Pancreatitis	0/5	0.00	0.00–3.20	0.577
Fever and fatigue	2/2	Infinity	2.14 - Infinity	0.032*
Incidental finding	5/30	0.82	0.27–2.91	>0.999
Characteristics of disease
Tumor size (mean, cm^2)	5.271		−5.08–2.87	0.578
Bile duct dilatation	3/12	1.84	0.47–8.29	0.415
Pancreatic duct dilatation	2/7	1.90	0.34–11.14	0.606
Pathologic type
Non-IN	4/35	0.40	0.13–1.45	0.235
LIN	0/11	0.00	0.00–1.33	0.199
HIN	10/28	6.11	1.62–19.01	0.005**
NT	0/2	0.00	0.00–9.71	>0.999
Interventions
Submucosal injection	1/13	0.32	0.03–2.29	0.441
Type of resection
En bloc	12/61	1.59	0.35–7.82	0.723
Piecemeal
Hemostasis
Metal clips	12/63	1.29	0.27–6.45	>0.999
Hemostatic sealant	1/22	0.15	0.01–0.96	0.050*
Epinephrine	4/17	1.51	0.46–5.07	0.502
Stent implantation
Pancreatic stent	6/30	1.19	0.34–3.47	0.772
Biliary stent	0/23	0.00	0.00–0.44	0.007**
Double stent	6/15	3.48	0.98–11.72	0.071
Non stent	2/8	1.56	0.29–7.66	0.635
Pancreatography	10/39	2.85	0.79–8.83	0.139

Notes: * P ≤ 0.05, ** P ≤ 0.01.

Abbreviations: non-IN, non-intraepithelial neoplasia; HIN, high-grade intraepithelial neoplasia; LIN, low-grade intraepithelial neoplasia; NT, neuroendocrine tumor; OR, odds ratio; CI, confidence interval.

Table 6 Multivariate Analysis of Post-EP Complications

Variable	Overall Complications				Pancreatitis				Bleeding
	n in Complication Cases /Total n of Occurance	OR	95% CI	P	n in Pancreatitis Cases /Total n of Occurance	OR	95% CI	P	n in Bleeding Cases /Total n of Occurance	OR	95% CI	P
Pathologic type
Non-IN	7/35	Reference group			3/35	Reference group			4/35	Reference group
LIN	3/11	1.64	0.26–9.53	0.578	3/11	2.89	0.43–19.68	0.260	0/11	1.65	0.07–21.67	0.706
HIN	18/28	9.81	2.75–44.04	0.001***	13/28	11.66	2.91–62.50	0.001***	10/28	6.52	1.45–46.77	0.027*
Hemostatic sealant	8/22	5.46	0.94–49.24	0.080	Not applied				1/22	0.16	0.01–1.22	0.090
Stent implantation
Pancreatic stent	15/30	2.07	0.47–9.99	0.342	12/30	7.61	1.37–64.53	0.033*	6/30	0.48	0.10–2.31	0.355
Biliary stent	4/23	0.11	0.008–0.99	0.050*	4/23	2.39	0.35–21.63	0.391	0/23	0.02	0.0006–0.37	0.017*
Non stent	2/8	1.85	0.19–17.75	0.588	0/8	1.93	0.07–31.48	0.645	2/8	2.16	0.23–24.33	0.501
Double stent	7/15	Reference group			3/15	Reference group			6/15	Reference group

Note: * P ≤ 0.05, ***P ≤ 0.001.

Abbreviations: non-IN, non-intraepithelial neoplasia; HIN, high-grade intraepithelial neoplasia; LIN, low-grade intraepithelial neoplasia; OR, odds ratio; CI, confidence interval.