
==== Front
Chin Med J (Engl)
Chin Med J (Engl)
CM9
Chinese Medical Journal
0366-6999
2542-5641
Lippincott Williams & Wilkins Hagerstown, MD

38809090
CMJ-2023-308
10.1097/CM9.0000000000002893
00010
3
Original Article
Impact of pancreatic and biliary stent on post-endoscopic papillectomy complications: A single-center retrospective study
Ru Nan 1
Chai Ningli 2
Zhang Bo 2
Li Longsong 1
Bi Yawei 2
Linghu Enqiang 1
Li Jinjiao
Ji Yuanyuan
1 Department of Gastroenterology, The First Medical Center of Chinese People's Liberation Army General Hospital, Beijing 100853, China
2 Digestive Endoscopy Center, The First Medical Center of Chinese People's Liberation Army General Hospital, Beijing 100853, China.
Correspondence to: Prof. Enqiang Linghu, Department of Gastroenterology, The First Medical Center of Chinese People's Liberation Army General Hospital, Beijing 100853, China E-Mail: linghuenqiang@vip.sina.com;Prof
Ningli Chai, Digestive Endoscopy Center, The First Medical Center of Chinese People's Liberation Army General Hospital, Beijing 100853, China E-Mail: csxlily@163.com
27 5 2024
05 9 2024
137 17 21112118
20 10 2023
Copyright © 2024 The Chinese Medical Association, produced by Wolters Kluwer, Inc. under the CC-BY-NC-ND license.
2024
https://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0

Abstract

Background:

Endoscopic papillectomy (EP) is recommended as the first-line therapy for ampullary tumors, despite a relatively high incidence of complications. Pancreatic and/or biliary stents are placed at the endoscopist's discretion to prevent post-EP complications. The present study aimed to evaluate the efficacy of different stents.

Methods:

A total of 117 patients who underwent EP and met the criteria between June 2006 and October 2022 were enrolled in the study. These patients were divided into a pancreatic stent group (PS group, n = 47), a biliary stent group (BS group, n = 38), and a two-stent group (PBS [PS and BS] group, n = 32). Relevant clinical data were collected and compared among the three groups. Multivariate logistic analyses were performed to explore risk factors for post-EP complications.

Results:

The incidence of all complications was 37.6% (44/117). Pancreatitis and hemorrhage were the two most common complications with incidence rates of 14.5% (17/117) and 17.9% (21/117). The incidence rates of post-EP pancreatitis were 10.6% (5/47), 23.7% (9/38), and 9.4% (3/32) in the PS group, BS group, and PBS group, respectively, with no significant differences. There were also no significant differences in other complications among the three groups. Age (odds ratio [OR]: 0.95; 95% confidence interval [CI]: 0.91–0.99; P = 0.022) was independently associated with post-EP pancreatitis while tumor size (OR: 1.66; 95% CI: 1.06–2.60; P = 0.028) was independently associated with post-EP hemorrhage.

Conclusions:

While pancreatic stenting is the first choice to prevent post-EP pancreatitis, biliary stenting could also be considered as a substitute for patients with difficulties in pancreatic cannulation. Two-stent (biliary and pancreatic stent) placement is unnecessary unless it is required due to other concerns.

Keywords:

Endoscopic papillectomy
Complications
Preventive measures
Pancreatitis
Hemorrhage
OPEN-ACCESSTRUE
==== Body
pmcIntroduction

Ampullary tumors are relatively rare with a prevalence of only 0.04–0.12% in autopsy studies[1,2] and represent 5% of all gastrointestinal tumors.[3] The detection rate has increased in the past few years with the spread of esophagus-gastro-duodenoscopy and endoscopic retrograde cholangiopancreatography (ERCP). Complete resection is typically recommended for ampullary tumors due to the high malignancy risk ranging from 26% to 65%[4] according to the adenoma–adenocarcinoma sequence.[5] Furthermore, Complete resection of ampullary tumors is also necessary because of poor diagnostic accuracy with false-negative rates of up to 30% and diagnostic discrepancy of postprocedural pathologic results, reported as 38.3–85%, with preprocedural endoscopic biopsy.[6]

Compared with surgical treatment, endoscopic papillectomy (EP) for ampullary tumors has been widely performed and recommended as the first-line therapy[6] for adenomas and early-stage tumors because of its low invasiveness, satisfying treatment outcomes, fewer adverse events, and lower cost.[7,8] Nonetheless, EP is still considered a high-risk procedure for non-negligible complications, with an incidence rate of 6.1–58.3%.[9] Of these, postprocedural pancreatitis is a frequent and potentially lethal complication,[10] reported in 3.8–33% of patients.[11–14] Although most conditions are mild to moderate, postprocedural pancreatitis incurs lengthy hospital stays, invasive intervention, and higher medical expenditure and can be life-threatening.

Prophylactic pancreatic stent placement has been recommended in international expert consensus and guidelines to prevent post-EP pancreatitis.[6,15] Pancreatic stent may play a role in improving intra-pancreatic duct pressure and preventing pancreatic duct stenosis due to papillary edema and scarring.[16] One randomized controlled trial has shown a significantly higher rate of pancreatitis in the unstented group (33%) compared to none in the stented group (P = 0.02).[14] And a meta-analysis by Spadaccini et al[10] has shown that the only factor affecting acute pancreatitis was same-session prophylactic pancreatic stent placement (OR: –1.72, 95% CI: –2.95 to –0.50; P = 0.006).

However, pancreatic stent placement is a challenging procedure even in experienced hands. Repeated cannulation could increase the risk of pancreatitis. Thus, biliary stent placement is a common alternative option for preventing post-EP complications for some endoscopists, especially when it is difficult to superselect the pancreatic duct with the guidewire. Besides, some experts also have the preference to place both pancreatic and biliary stents. Biliary stent placement individually or simultaneously has been reported in several studies.[17–19] In addition to their potential efficacy to prevent cholangitis as well as papillary stenosis after EP, our previous study provided a novel theory that biliary stent placement could isolate bile from pancreatic juice and, therefore, reduce the incidence of post-EP pancreatitis.[20] The efficacy of different stent types in preventing post-EP pancreatitis, as well as other complications, is still unclear.

Herein, we conducted a retrospective study in a high-volume referral center, aiming to evaluate the efficacy of prophylactic pancreatic and/or biliary stent placement for post-EP pancreatitis. Their effect on the other postprocedural complications and the potential risk factors for postprocedural pancreatitis and hemorrhage were also explored.

Methods

Patients

Consecutive patients who had undergone EP between June 2006 and October 2022 at the endoscopy center of the First Medical Center of Chinese PLA General Hospital were retrospectively enrolled in this study. All of the diagnostic and therapeutic procedures were carried out according to approved guidelines. The patients' medical records were reviewed for data on patients' characteristics (age, sex, body mass index [BMI], history of smoking and drinking, etc.), lesions' characteristics (lesion size, histological diagnosis, etc.), and procedure-related characteristics (submucosal injection before resection, type of tumor resection, prophylactic plastic pancreatic and/or biliary stent placement, sphincterotomy, hemostatic measures, etc.).

The exclusion criteria were (1) patients exsiting treatment history of ampullary tumors, (2) patients with no stent placement, and (3) patients experiencing novel EP with wound surface protection by metal clips and fibrin glue. According to the type of stents, patients were divided into three groups: pancreatic stent placement group (PS group), biliary stent group (BS group), and both pancreatic and biliary stents placement group (PBS group). The study was approved by the Institutional Review Board of Chinese People's Liberation Army General Hospital (No. S2024-109-03).

EP procedures

Preoperative endoscopic examination and biopsy were performed to assess the lesion. Endoscopic ultrasonography was performed for lesions with suspected submucosal invasion and intraductal ultrasonography was used for evaluating the intraductal extension of the tumor optionally.

Single-channel gastroscope (GIF Q260J; Olympus, Tokyo, Japan), Snare (SD-7P-1/SD-221L-25; Olympus, Tokyo, Japan), High-frequency generator (VIO 200D; ERBE, Tübingen, Germany), and Argon Plasma Coagulation(APC) unit (APC300; ERBE, Tübingen, Germany) were used during the procedure.

The details of the procedure were in accordance with the previous publication.[18] All procedures were performed under intravenous anesthesia. A carbon dioxide (CO2) insufflator was used during the treatment. Submucosal injection with 1:10,000 diluted epinephrine was not performed routinely but could be selected at the discretion of the endoscopists. The ampullary lesion was snared at the base by a polypectomy snare via the endoscopic biopsy port, and constant tension was applied. Standard electrocautery was used to transect the lesion. Initially, en bloc resection was attempted in all patients; in cases of large adenomas or grossly remnant lesions after the first snaring, a piecemeal approach was performed. APC and forceps (FD-410 LR, Olympus) were also sometimes used for small residual tumors to ensure therapeutic success. Endoscopic sphincterotomy and pancreatic and/or biliary stents were placed at the endoscopist's discretion according to the operational process. The electric coagulation, injection of saline solution with epinephrine, APC, and clips were selected for hemostasis during the endoscopic procedures. Stent placement was checked under X-ray.

After the procedure, patients were admitted for close observation, and therapeutic fasting was maintained. All patients received proton pump inhibitors, antibiotics, and somatostatin for 1–3 days routinely. Bile/pancreatic stents were removed within three months if no significant papillary stricture was observed. Endoscopic follow-up was scheduled after 3, 6, and 12 months for the first year and then yearly for the following 5 years.

Outcomes and definitions

The main outcome was the development of post-EP pancreatitis. Secondary outcomes were the severity of post­EP pancreatitis (graded to mild, moderate, severe as following described), the incidence of other post­EP complications (including hemorrhage, perforation, and biliary stenosis), and transient adverse events (TAEs, including fever and hyperamylasemia).

Post-procedural pancreatitis was defined as clinical pancreatitis, meeting two of the following three criteria in accordance with the Revised Atlanta International consensus,[21] including pain consistent with acute pancreatitis, amylase or lipase more than three times the upper normal limit, and characteristic findings on imaging. The severity was graded mild if with no local or systemic complications and an uneventful recovery; moderate if with transient organ failure, local complications, or exacerbation of co-morbid disease present; or severe if there existed persistent organ failure lasting over 48 h. Hemorrhage was defined as a progressive drop in hemoglobin after the procedure or active bleeding found in postoperative or follow-up endoscopy. Patients with increased serum amylase levels, in the absence of any other parameter for acute pancreatitis (AP), were classified as having hyperamylasemia.

Statistical analysis

For continuous variables, tests of data normality were carried out using the Shapiro–Wilk test. Normally distributed variables were presented as mean ± standard deviation (SD) and compared using Student's t-tests or analysis of variance. Non-normally distributed variables were presented as median (interquartile range [IQR]) and compared using the Wilcoxon rank sum test or the Kruskal–Wallis H test. Categorical variables were presented as frequencies and percentages. Chi-squared analysis or Fisher's exact test was used for comparison of categorical variables. Two-sided P values less than 0.05 were considered statistically significant. P values for pairwise comparisons were adjusted using the Bonferroni correction. Variables with a P value of <0.10 were considered in multivariate logistic regression models by using stepwise backward selection to identify the independent predictive factors. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. Data were analyzed using SPSS version 23 (SPSS Inc., Chicago, IL, USA).

Results

Patient characteristics

As shown in Figure 1, there were 189 patients treated with EP from June 2006 to October 2022 at our endoscopy center. A total of 72 patients were excluded from the study, including 8 patients with treatment history of ampullay tumors, 34 patients with no stent placement, and 30 patients experiencing the novel EP. Finally, 117 patients (62 males, 53.0%) were enrolled in the present study. Based on stent placement, 47 patients were divided into the PS group while 38 patients were divided into the BS group and 32 patients into the PBS group.

Figure 1 Flow diagram of patient enrollment.

A detailed description of the characteristics of the enrolled patients is shown in Table 1. The median (IQR) tumor size was 1.5 (1.0–2.0) cm. En bloc resection was achieved in 99 patients (99/117, 84.6%) while R0 resection was achieved in 83 patients (83/117, 70.9%). The median (IQR) procedural time was 40 (30–59) min and the median (IQR) postoperative hospital stay was nine (7–12) days.

Table 1 Patient- and procedural-related characteristics of enrolled patients experiencing EP and comparisons according to stent types (PS, BS, and PBS).

Characteristics	Total (N = 117)	PS group
(n = 47)	BS group
(n = 38)	PBS group
(n = 32)	Statistical values	P-values	
Patient-related							
Age (years)	58.7 ± 12.2	56.9 ± 12.2	59.1 ± 11.5	60.9 ± 13.1	1.033‡	0.359	
Male, n (%)	62 (53.0)	28 (59.6)	19 (50.0)	15 (46.9)	1.435§	0.488	
Body mass index (kg/m2)	23.87 ± 3.18	23.80 ± 3.21	24.2 ± 3.40	23.56 ± 2.93	0.350‡	0.706	
Smoking, n (%)	25 (21.4)	13 (27.7)	8 (21.1)	4 (12.5)	2.607§	0.272	
Drinking, n (%)	29 (24.8)	13 (27.7)	11 (28.9)	5 (15.6)	2.002§	0.368	
Complaints, n (%)					2.180§	0.703	
Asymptomatic	49 (41.9)	19 (40.4)	19 (50.0)	11 (34.4)			
Abdominal symptoms	52 (44.4)	21 (44.7)	14 (36.8)	17 (53.1)			
Non-abdominal symptoms	16 (13.7)	7 (14.9)	5 (13.2)	4 (12.5)			
Previous pancreatitis, n (%)	11 (9.4)	5 (10.6)	2 (5.3)	4 (12.5)	1.209§	0.546	
Procedural-related							
Submucosal injection before resection, n (%)	12 (10.3)	5 (10.6)	2 (5.3)	5 (15.6)	2.039§	0.361	
Endoscopic sphincterotomy, n (%)	28 (23.9)	8 (17.0)	5 (13.2)	15 (46.9)*,†	12.909§	0.002	
Hemostasis, n (%)							
Metal clip	89 (76.1)	30 (63.8)	30 (78.9)	29 (90.6)*	7.765§	0.021	
Argon plasma coagulation	4 (3.4)	2 (4.3)	2 (5.3)	0 (0)	1.624§	0.444	
Epinephrine injection	30 (25.6)	11 (23.4)	4 (10.5)	15 (46.9)†	12.244§	0.002	
Electrocoagulation	16 (13.7)	5 (10.6)	6 (15.8)	5 (15.6)	0.614§	0.736	
Tumor size (cm)	1.5 (1.0–2.0)	1.5 (1.2–2.0)	1.2 (1.0–2.0)	2.0 (1.5–2.5)*,†	9.964||	0.007	
Type of resection, n (%)					1.854§	0.396	
En bloc	99 (84.6)	42 (89.4)	32 (84.2)	25 (78.1)			
Piecemeal	18 (15.4)	5 (10.6)	6 (15.8)	7 (21.9)			
R0 resection, n (%)	83 (70.9)	37 (78.7)	27 (71.1)	19 (59.4)	3.458§	0.178	
Final histological diagnosis, n (%)					11.881§	0.293	
Adenoma	30 (25.6)	17 (36.2)	8 (21.1)	5 (15.6)			
Inflammatory lesion	12 (10.3)	5 (10.6)	5 (13.2)	2 (6.3)			
Low-grade dysplasia	23 (19.7)	8 (17.0)	10 (26.3)	5 (15.6)			
High-grade dysplasia	25 (21.4)	9 (19.1)	7 (18.4)	9 (28.1)			
Adenocarcinoma	21 (17.9)	6 (12.8)	5 (13.2)	10 (31.3)			
Others	6 (5.1)	2 (4.3)	3 (7.9)	1 (3.1)			
Procedural time (min)	40.0 (30.0–58.8)	30.0 (23.5–40.0)	40.0 (30.0–50.0)	60.0 (45.0–75.0)*,†	30.012||	<0.001	
Postoperative hospital stay (days)	9.0 (7.0–12.0)	8.0 (7.0–11.5)	9.5 (7.2–11.8)	10.0 (7.0–12.3)	3.174||	0.205	
Normally distributed continuous variables were presented as mean ± standard deviation and non-normally distributed variables were presented as median (interquartile range). *Significantly different from the PS group. †Significantly different from the BS group. ‡F values. §Chi-squared values; ||H values. BMI: Body mass index; BS: Biliary stent. EP: Endoscopic papillectomy; PS: Pancreatic stent; PBS: Pancreatic and biliary stents.

As for the comparisons among the three groups, more patients experienced sphincterotomy in the PBS group than in the other two groups (46.9% [15/32] vs. 17.0% [8/47] vs. 13.2% [5/38]). The usage rate of metal clips for hemostasis and wound closure in the PBS group was significantly higher than the PS group (90.6% [29/32] vs. 63.8% [30/47]). The usage rate of epinephrine in the PBS group was significantly higher than the BS group (46.9% [15/32] vs. 10.5% [4/38]). The tumor size was significantly larger in the BPS group than in the other two groups, and so was the procedural time. There was no significant difference in the other characteristics among the three groups.

Outcomes

As shown in Table 2, the incidence rates of all complications and TAEs were 37.6% (44/117) and 45.3% (53/117). Post-EP pancreatitis occurred in 17 patients (14.5%), including 15 stratified as mild/moderate and two as severe. Post-EP hemorrhage occurred in 21 patients with an incidence rate of 17.9%. Among these patients, 14 experienced endoscopic therapy, 12 received blood transfusions, and one was treated with artery embolization. The incidence rate of biliary stenosis was 2.6% (3/117). As for TAEs, there were 38 patients (32.5%) experiencing hyperamylasemia and 15 patients (12.8%) experiencing fever. There was no significant difference in the post-procedural complications and TAEs among the three groups.

Table 2 Post-endoscopic papillectomy complications comparisons according to stent types (PS, BS, and PBS).

Outcomes	Total
(N = 117)	PS group
(n = 47)	BS group
(n = 38)	PBS group
(n = 32)	Chi-squared values	P-values	
All complications	44 (37.6)	16 (34.0)	14 (36.8)	14 (43.8)	0.779	0.678	
Pancreatitis	17 (14.5)	5 (10.6)	9 (23.7)	3 (9.4)	3.822	0.148	
Mild/moderate	15 (12.8)	4 (8.5)	8 (21.1)	3 (9.4)	3.425	0.180	
Severe	2 (1.7)	1 (2.1)	1 (2.6)	0 (0)	0.798	0.671	
Hemorrhage	21 (17.9)	7 (14.9)	5 (13.2)	9 (28.1)	3.140	0.208	
Biliary stenosis	3 (2.6)	2 (4.3)	0 (0)	1 (3.1)	1.578	0.454	
All TAEs	53 (45.3)	20 (42.6)	19 (50.0)	14 (43.8)	0.513	0.774	
Hyperamylasemia	38 (32.5)	15 (31.9)	13 (34.2)	10 (31.3)	0.081	0.960	
Fever	15 (12.8)	5 (10.6)	6 (15.8)	4 (12.5)	0.503	0.778	
Data are presented as n (%). BS: Biliary stent; PBS: Pancreatic and biliary stents; PS: Pancreatic stent; TAE: Transient adverse event.

Analysis of risk factors for post-EP pancreatitis

The characteristics of the patients with and without post-EP pancreatitis are described in Table 3. In the univariate analysis, age (P = 0.017) was found to be significantly associated with post-EP pancreatitis. Variables with P <0.100, including age and complaints (P = 0.062), were then included in a multivariate logistic regression analysis. The results showed only age (OR: 0.95; 95% CI: 0.91–0.99; P = 0.022) was independently associated with post-EP pancreatitis.

Table 3 Univariate and multivariate analysis of factors for post-EP pancreatitis.

Characteristics	Patients with post-EP pancreatitis (n = 17)	Patients without post-EP pancreatitis (n = 100)	Univariate P values	Multivariate P values	Adjusted OR (95% CI)	
Patient-related						
Age (years)	52.2 ± 12.4	59.8 ± 11.9	0.017	0.022	0.95 (0.91–0.99)	
Male	7 (41.2)	55 (55.0)	0.291	–	–	
Body mass index (kg/m2)	23.14 ± 2.87	23.99 ± 3.23	0.310	–	–	
Smoking	3 (17.6)	22 (22.0)	1.000	–	–	
Drinking	4 (23.5)	25 (25.0)	1.000	–	–	
Complaints			0.062	NS	–	
Asymptomatic	11 (64.7)	38 (38.0)		–	–	
Abdominal symptoms	6 (35.3)	46 (46.0)		–	–	
Non-abdominal symptoms	0 (0)	16 (16.0)		–	–	
Previous pancreatitis	1 (5.9)	10 (10.0)	1.000	–	–	
Procedural related						
Submucosal injection before resection	3 (17.6)	9 (9.0)	0.379	–	–	
Endoscopic sphincterotomy	6 (35.5)	22 (22.0)	0.235	–	–	
Stents			0.148	–	–	
Biliary stent only	9 (52.9)	29 (29.0)		–	–	
Pancreatic stent only	5 (29.4)	42 (42.0)		–	–	
Both pancreatic and biliary stents	3 (17.6)	29 (29.0)		–	–	
Hemostasis						
Metal clip	15 (88.2)	74 (74.0)	0.355	–	–	
Argon plasma coagulation	1 (5.9)	3 (3.0)	0.471	–	–	
Epinephrine injection	4 (23.5)	26 (26.0)	1.000	–	–	
Electrocoagulation	1 (5.9)	15 (15.0)	0.461	–	–	
Tumor size (cm)	1.2 (1.0–1.5)	1.6 (1.0–2.0)	0.143	–	–	
Type of resection			1.000	–	–	
En bloc	15 (88.2)	84 (84.0)		–	–	
Piecemeal	2 (11.8)	16 (16.0)		–	–	
Procedural time (min)	40 (30–50)	35 (25–60)	0.978	–	–	
Data are presented as mean ± standard deviation or n (%). –: Not available; CI: Confidence interval; EP: Endoscopic papillectomy; NS: Not significant; OR: Odds ratio.

Analysis of risk factors for post-EP hemorrhage

The characteristics of the patients with and without post-EP hemorrhage were described in Table 4. In the univariate analysis, tumor size (P = 0.005) and procedural time (P = 0.008) were found to be significantly associated with post-EP hemorrhage. Variables with P <0.100, including tumor size, procedural time and metal clips (P = 0.093) and endoscopic sphincterotomy (P = 0.093), were then included in a multivariate logistic regression analysis. The results showed only tumor size (OR: 1.66; 95% CI: 1.06–2.60; P = 0.028) was independently associated with post-EP hemorrhage.

Table 4 Univariate and multivariate analysis of factors for post-EP hemorrhage.

Characteristics	Patients with post-EP hemorrhage (N = 21)	Patients without post-EP hemorrhage (N = 96)	Univariate P value	Multivariate P value	Adjusted OR (95% CI)	
Patient-related						
Age (years)	56.9 ± 14.5	59.1 ± 11.7	0.455	–	–	
Male	12 (57.1)	50 (52.1)	0.674	–	–	
Body mass index (kg/m2)	23.35 ± 3.79	23.98 ± 3.04	0.427	–	–	
Smoking	7 (33.3)	18 (18.8)	0.151	–	–	
Drinking	6 (28.6)	23 (24.0)	0.657	–	–	
Complaints			0.216	–	–	
Asymptomatic	6 (28.6)	43 (44.8)		–	–	
Abdominal symptoms	10 (47.6)	42 (43.8)		–	–	
Non-abdominal symptoms	5 (23.8)	11 (44.4)		–	–	
Previous pancreatitis	0 (0)	11 (11.5)	0.210	–	–	
Procedural related						
Submucosal injection before resection	3 (14.3)	9 (9.4)	0.449	–	–	
Endoscopic sphincterotomy	8 (38.1)	20 (20.8)	0.093	NS	–	
Stents			0.158	–	–	
Biliary stent only	5 (23.8)	40 (41.7)		–	–	
Pancreatic stent only	7 (33.3)	33 (34.4)		–	–	
Both pancreatic and biliary stents	9 (42.9)	23 (24.0)		–	–	
Hemostasis						
Metal clip	13 (61.9)	76 (79.2)	0.093	NS	–	
Argon plasma coagulation	1 (4.8)	3 (3.1)	0.552	–	–	
Epinephrine injection	8 (38.1)	22 (22.9)	0.149	–	–	
Electrocoagulation	4 (19.0)	12 (12.5)	0.484	–	–	
Tumor size (cm)	2.0 (1.5–3.0)	1.5 (1.0–2.0)	0.005	0.028	1.66 (1.06–2.60)	
Type of resection			0.313	–	–	
En bloc	16 (76.2)	83 (86.5)		–	–	
Piecemeal	5 (23.8)	13 (13.5)		–	–	
Procedural time (min)	53 (43–75)	38 (30–54)	0.008	NS	–	
Data were presented as mean ± standard deviation or n (%). –: Not available; CI: Confidence interval; EP: Endoscopic papillectomy; NS: Not significant; OR: Odds ratio.

Discussion

In this retrospective study, there was no significant difference in the incidence of post-EP pancreatitis and other complications among different stents placement groups. Furthermore, the multivariate analyses showed that age was the only factor significantly associated with post-EP pancreatitis while tumor size was significantly associated with post-EP hemorrhage.

Since EP was first introduced by Suzuki et al[22] in 1983, many reports have demonstrated its feasibility, and today, EP is considered the first-line therapy for duodenal ampullary adenoma beyond an alternative therapy to surgical resection. However, post-EP complications cannot be ignored. Post-EP pancreatitis is one of the most common and concerning complications, which is probably caused by obstruction to the outflow of pancreatic juice,[23] contrast dye injection into the pancreatic duct,[24] or electrical current injury during papillectomy and/or sphincterotomy.[25] Although conflicts exist in different studies,[14,26–29] prophylactic pancreatic stenting has been confirmed effective in many studies and, therefore, recommended in international guidelines and used widely.

However, it has to be stressed that pancreatic duct cannulation and stent placement are technically difficult even for experienced endoscopists. It would be much more challenging in EP due to bleeding, edema, or cautery artifact after resection.[23] Multiple attempts at cannulation of the papilla through a difficult-to-access orifice require more time and involve more manipulation of the papillary complex. This may predispose to pancreatitis due to the added mechanical trauma.[30] In this circumstance, biliary stenting is considered a substitute for some endoscopists. Compared to the pancreatic duct, the biliary duct is generally thought easier to cannulate, and therefore, the placement is less likely to introduce injury. The study on the effect of biliary stent is still weak.

The present study is novel to explore the effect of different stent types on post-EP complications and revealed no significant difference. The multivariate analyses on the risk factors for post-EP pancreatitis and hemorrhage also revealed no associations with stent types. The biliary stent was considered an alternate option for the following reasons. First, biliary stents could benefit patients by helping bile drainage and preventing bile reflux-induced pancreatitis and bile-induced wound bleeding.[20] Second, biliary stents might prevent post-EP papillary stenosis to help pancreatic juice drainage. Third, choosing biliary stenting timely also prevents damage to the pancreas during pancreatic stenting, such as repeated cannulation and contrast dye injection into the pancreatic duct. Therefore, for patients with difficulties in pancreatic cannulation, biliary stenting could also be considered as a substitute to prevent post-EP pancreatitis. However, it should be stressed that although no significant differences existed, the incidence of post-EP pancreatitis in the BS group is 23.7% (9/38), which is higher than the other two groups. The result prompts that pancreatic stenting might still be preferred to prevent post-EP pancreatitis, which needs further prospective study. Besides, there was no distinct advantage for the BPS group, indicating that two stents placement might be unnecessary unless it is required due to other concerns.

In the multivariate analyses, older age was identified as an independent protective factor for post-EP pancreatitis. This could be explained by the physical decay of pancreatic exocrine function with age. Besides, age was also identified as an independent factor for post-ERCP pancreatitis.[31] Larger tumor size was identified as a risk factor for post-EP hemorrhage, which was in accordance with previous studies.[11,19] The richer blood supply, the larger lesions, and the more difficulties in hemostasis in larger tumors provide more risk for post-EP hemorrhage. The risk factors identified in the present study were easy to obtain in clinical work. These "easy to identify" subgroups of patients should receive particular attention in post-EP days, in order to reduce that risk or, at least, to be able to manage it in a safe setting.[19]

We acknowledge that this study could present several limitations. First, it was a retrospective study that some potential risk factors of post-EP complications were not included. Sample size and selection bias may also influence the above results. Second, this was a single-center study conducted in a tertiary referral center. The generalization of the results should be considered. However, we thought the results from highly experienced operators could represent a solid base for future research in the field. Third, stent placement is routine in our center. Most patients without stent placement had experienced repeated cannulation, which might damage the pancreas. Thus, the present study excluded patients with no stent placement. Future research requires a multicenter, large-sample, and prospective design to eliminate the effects of confounding factors.

In conclusion, while pancreatic stenting is the first choice to prevent post-EP pancreatitis, biliary stenting could also be a substitute for patients with difficulties in pancreatic cannulation. Both biliary and pancreatic stent placement is unnecessary unless it is required due to other concerns.

Funding

The present study was supported by grants from the National Natural Science Foundation of China (No. 82070682), China Postdoctoral Science Foundation (No. 2023T160785), and Innovative Talents Promotion Plan (No. 2019RA2154).

Conflicts of interest

None.

Nan Ru and Bo Zhang contributed equally to this work.

How to cite this article: Ru N, Chai NL, Zhang B, Li LS, Bi YW, Linghu EQ. Impact of pancreatic and biliary stent on post-endoscopic papillectomy complications: A single-center retrospective study. Chin Med J 2024;137:2111–2118. doi: 10.1097/CM9.0000000000002893
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