Characteristics of and risk factors for early migration of biliary plastic stents after stone removal with endoscopic retrograde cholangiopancreatography

doi:10.21203/rs.3.rs-4895140/v1

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Characteristics of and risk factors for early migration of biliary plastic stents after stone removal with endoscopic retrograde cholangiopancreatography

https://doi.org/10.21203/rs.3.rs-4895140/v1

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Background and Aims: Biliary plastic stents often fall off prematurely or shift from the duodenal papilla can cause recurrent biliary tract infection or intestinal perforation. We aimed to investigate the incidence of and risk factors for early migration of biliary plastic stents after ERCP.

Methods: The study population underwent ERCP for bile duct stone removal and placement of biliary plastic stents were analyzed from March 2018 to December 2022. Patient data was obtained through the electronic medical records.

Results: A total of 836 patients (60.40±15.58 years, 511 males) were included. 105 patients showed early stent migration, of which 91 (10.9%) patients showed early stent shedding, and 14 (1.7%) patients showed displacement of stent. Multivariate logistic regression analysis showed that the risk of early stent migration was significantly higher in patients with a duodenal diverticula (OR = 2.367, P= 0.005), duodenal sphincter incision (OR = 3.638, P = 0.007), and longer stents (OR = 0.423, P＜0.001). The Christmas tree plastic stent was significantly less prone to early migration than the conventional biliary plastic stent (OR = 2.654, P = 0.034). The risk of stent displacement significantly increased with the degree of balloon dilatation (OR = 2.708, P= 0.043) and with the presence of diverticula in the descending part of the duodenum (OR = 6.412, P = 0.002).

Conclusion: Early stent migration often occurs after ERCP. Therefore, patients with risk factors for early stent migration should be followed up carefully.

Endoscopic retrograde cholangiopancreatography

Biliary duct plastic stent

Stent migration

Risk factors

Choledocolithiasis is a common and frequently occurring disease of the digestive system. Endoscopic retrograde cholangiopancreatography (ERCP) is the preferred method for the treatment of common bile duct (CBD) stones, irrespective of the patient’s age^{[1]. To prevent acute cholangitis or displacement of gallstones to the bile duct as a result of postoperative bile duct outlet obstruction from papillary sphincter edema to the bile duct, endoscopic biliary plastic stents have been widely used for stable biliary drainage after ERCP, and the success rate of this technique is close to 100%}^[2].While biliary plastic stent implantation offers multiple advantages in the early postoperative period, including good drainage and low adverse event rates, long-term retention of biliary stents can cause adverse events such as stent occlusion, recurrence of bile duct stones, or acute cholangitis. Therefore, removal of these stents within 1–3 months postoperatively has been recommended^{[3]. While premature shedding or displacement of the biliary stent from the CBD has been occasionally reported, and most of the detached stents are excreted from the body through intestinal peristalsis, a few studies have reported that the detached biliary stents can cause colonic perforation}^{[4]. Moreover, plastic stents that are displaced into the biliary tract can induce recurrent biliary obstruction or infection, often necessitating repeat ERCP to remove the residual biliary plastic stent and clean the biliary tract again, which can increase the patients’ financial burden and increase the risk of postoperative adverse events.}The existing literature on the early migration of biliary plastic stents is scarce. Therefore, this study aimed to retrospectively analyze the relevant clinical data of patients who underwent ERCP for cholelithiasis at our center and explore the incidence of and risk factors for early migration of biliary plastic stents after stone removal with ERCP.

Patients

We investigated the findings for patients who underwent endoscopic extraction of CBD stones at the 900th Hospital of the Joint Logistic Support Force between March 2018 and December 2022. A total of 892 patients were treated during the study period, and the clinical data of these patients were retrospectively analyzed.

Inclusion criteria:

1) Patients aged 18–90 years who were considered to have choledocholithiasis on the basis of preoperative abdominal B-ultrasonography, computed tomography, magnetic resonance cholangiopancreatography, or ultrasonic gastroscopy, and eventually underwent stone removal with ERCP

2) Patients who received a temporary biliary plastic stent for internal drainage after ERCP

Exclusion criteria:

1) Previous history of biliary pancreatectomy
2) Cholangiolithiasis that could not be removed by ERCP and required long-term implantation of a plastic stent
3) Choledocholithiasis secondary to biliary pancreatic malignancy
4) Failure to return to the hospital within the prescribed time to remove the biliary stent
5) Relevant clinical data missing or lost to follow-up

A total of 836 patients with choledocholithiasis were finally included (Fig. 1). Retrospective analysis was performed using data for general patient characteristics (sex, age, body mass index), previous surgical history, endoscopic papillary sphincterotomy (EST) incision, stent type (model, length), stone removal method, bile duct angle, postoperative adverse events, and other relevant data of all eligible patients. This study was approved by the Ethics Committee of the 900th Hospital of the PLA (No. 2018XHNK03).

Endoscopic system

Japanese Olympus TJF-260 electronic duodenoscope or Pentax ED-341C, German ERBE high-frequency electric cutting device, Boston yellow zebra guidewire, Olympus nipple incision knife, stone balloon, stone-gravel integrated basket, and various types of biliary plastic stents (Boston) and snares were used for the procedures performed in this study.

ERCP procedure

All endoscopic procedures were performed by doctors with substantial experience (more than 3 years of experience and more than 1000 cases). The detailed steps were as follows: (1) Routine preoperative preparation for ERCP was performed by entering the descending part of the duodenum through the lumen with the duodenoscope. (2) The endoscopic body was straightened to find the main nipple. (3) Intubation into the mucosa was performed using the conventional mucosal incision knife with yellow zebra guide wire, and the number and size of bile duct stones was determined after exhaust angiography. (4) Depending on stone size and bile duct diameter, the choice between EST or endoscopic papillary balloon dilatation (EPBD) was selected until the desired dilation diameter was reached, and the stone was collected using a stone balloon or stone basket. (5) Complete removal of the stone was confirmed by cholangiography and a CBD plastic stent was routinely placed for internal drainage. (6) After the operation, fasting and inhibition of pancreatic secretion were ensured along with fluid rehydration and other treatments as necessary. Close attention was paid to the changes in patients’ vital signs, and routine blood parameters, blood amylase and C-reactive protein (CRP) levels, and other indices of patients were monitored at 3 h and 24 h after surgery.

Follow-up procedure

Abdominal plain radiography was repeated within 1 month after ERCP to determine the position of the biliary plastic stent. If the biliary stent was in a good position, snare removal under a gastroscope was considered feasible. However, if the biliary stent was displaced to the intrahepatic bile duct or the middle and upper parts of the CBD, a stone balloon combined with a snare was used to recover the stent under ERCP guidance. The patients underwent telephone follow-up assessments after the operation, and abdominal pain, jaundice, fever, and other related symptoms were recorded. If necessary, routine blood evaluation as well as measurement of blood amylase, CRP, and other indicators were performed to determine the presence of acute cholangitis or acute pancreatitis. If the stent had fallen off into the intestinal cavity, abdominal plain radiographs were regularly obtained to clarify changes in the stent position until the stent was discharged from the intestinal tract. During this period, the appearance of abdominal pain and fever was closely monitored.

Adverse events after ERCP

The following adverse events after ERCP were monitored in this study: (1) post-ERCP hyperamylasemia: elevated blood amylase levels more than 3 times the normal value with no obvious clinical symptoms 24 h after surgery; (2) acute pancreatitis after ERCP: clinical symptoms of acute pancreatitis along with elevated blood amylase levels more than 3 times the normal value 24 h after surgery; (3) ERCP-related bleeding: hematemesis, black stool, etc., during endoscopic procedures along with a decrease of ≥ 30 g/L in hemoglobin levels.

Early migration of biliary plastic scaffolds

Early migration of biliary plastic stent was categorized as follows: (1) biliary stent shedding: during the follow-up period of 1 month after ERCP, the biliary plastic stent fell off from the CBD and excreted itself (Fig. 2A); (2) stent displacement: during the follow-up period after ERCP, the plastic biliary stent migrated from the nipple to the middle and upper CBD, and no plastic biliary stent was found at the papillary opening (Fig. 2B).

Biliary plastic stent falls off into intestine.(B)The biliary plastic stent was moved inside the bile duct.

Statistical analysis

SPSS25.0 software was used for data analysis. Measurement data showing a normal distribution were expressed as mean ± standard deviation; median (P25, P75) was used for data showing a non-normal distribution; and count data were expressed as number (%). The differences between groups were evaluated by t test or Mann–Whitney U test. The counting data were expressed as constituent ratio or rate (%). Chi-square test was used to compare differences between the groups. Univariate analysis was performed for variables that may have been related to early migration of biliary plastic stents, and logistic regression analysis was subsequently performed, with p < 0.05 indicating statistical significance

A total of 892 patients with choledocholithiasis were treated with ERCP during the study period, and 836 patients (511 males and 325 females; mean age, 60.40 ± 15.58 years) were finally included in the study. The early migration group contained 105 patients, including 91 patients who showed early biliary stent shedding and 14 patients who showed biliary stent displacement to the CBD. All stents that were shed early were spontaneously discharged from the intestine, while stents that showed internal displacement to the CBD were removed by ERCP again. The specific demographic characteristics of the patients are shown in Table 1.

Table 1

Clinical features in patients showing early migration and no migration of the biliary plastic stent after stone removal with endoscopic retrograde cholangiopancreatography
Characteristics	No migration group (n = 731)	Early migration group (n = 105)	P value
Sex, male/female	447/284	64/41	0.897
Age, years	60.51 ± 15.77	59.63 ± 14.27	0.586
BMI (kg/m²)	23.13 (21.05, 25.11)	23.44 (21.83, 25.41)	0.231
Follow-up duration (days)	29 (27, 33)	30 (28,36)	0.072
EST	103 (14.1)	5 (4.8)	0.008
EPBD 1.0-1.5 cm 0–1.0 cm 0 cm	177 (24.2) 439 (60.1) 115 (15.7)	38 (36.2) 45 (42.9) 22 (20.9)	0.251
Pancreatic duct stent	41 (5.6)	8 (7.6)	0.412
Angulation of the bile duct (> 145^°)	43 (5.9)	10 (9.5)	0.152
Biliary stent length, cm < 7 ≥ 7	348 (47.6) 383 (52.4)	70 (66.7) 35 (33.3)	<0.001
Duodenal diverticula	56 (7.7)	17 (16.2)	0.004
Cholecystectomy	227 (31.1)	30 (28.6)	0.606
Post-gastrectomy	13 (1.8)	3 (2.9)	0.708
Biliary stent type Christmas tree-shaped stent Common plastic stent	76 (10.4) 655 (89.6)	4 (3.8) 101 (96.2)	0.032
Cystic duct diameter, mm < 8 ≥ 8	331 (45.3) 400 (54.7)	43 (41.0) 62 (59.0)	0.404

BMI, body mass index; EST, endoscopic papillary sphincterotomy; EPBD, endoscopic papillary balloon dilatation.

On the basis of the results shown in Table 1 and our clinical judgment, we determined that the potential factors related to early biliary plastic stent migration after ERCP for stone removal were papillary sphincter incision, the length of biliary stent, and the presence of diverticula. Using these factors as independent variables and the occurrence of early migration as a dependent variable, we performed multi-factor logistic regression. The results, which are presented in Table 2, showed that the length of the biliary stent and the presence of diverticula were independent risk factors for early migration of biliary plastic stents.

Table 2

Logistic regression analyses of the risk factors for early biliary plastic migration after stone removal with endoscopic retrograde cholangiopancreatography
Risk factors	OR (95% CI)	P value
EST	3.638 (1.435–9.255)	0.007
Duodenal diverticula	2.367 (1.300-4.307)	0.005
Biliary stent type (Christmas tree-shaped stent)	2.654 (1.002–5.112)	0.034
Biliary stent length (≥ 7 cm)	0.423 (0.273–0.655)	<0.001

OR, odds ratio; CI, confidence interval; EST, endoscopic papillary sphincterotomy.

Early shedding of biliary plastic stents was observed in 91 patients. During the follow-up period, all of these stents were spontaneously excreted with intestinal peristalsis, and no intestinal perforation or biliary stent retention occurred. In the group that did not show stent migration, the biliary plastic stents were pulled out under gastroscopic guidance after approximately 1 month, and no adverse effects occurred during the operation. Stent displacement to the middle and upper part of the CBD was observed in 14 patients, accounting for 13.3% of the cases showing early stent migration. All displaced stents were removed using ERCP again, and no ERCP-related adverse events occurred in these patients after operation.

On the basis of the results shown in Table 3 and our professional judgment, we determined that the factors related to the internal displacement of biliary stent were age, the status of biliary balloon dilatation, and the presence of diverticula. Using these factors as independent variables and the occurrence of internal displacement as a dependent variable, multivariate logistic regression analysis was performed. The results showed that the degree of balloon dilatation and the presence of diverticula were independent risk factors for early internal displacement of biliary plastic stent, as shown in Table 4.

Table 3

Comparison of clinical features between patients showing no displacement of biliary plastic stents and those showing biliary stent displacement after stone removal with endoscopic retrograde cholangiopancreatography
Characteristics	No displacement group (n = 822)	Stent displacement group (n = 14)	P value
Sex, male/female	501/321	10/4	0.425
Age, years	60.26 ± 15.56	69.07 ± 14.77	0.036
BMI (kg/m²)	23.36 (21.33, 25.15)	23.10 (20.62, 23.93)	0.370
Follow-up duration (days)	30 (27, 33)	33 (28, 36)	0.096
EST	108 (13.1)	0 (0.0)	0.146
EPBD 1.0-1.5 cm 0–1.0 cm 0 cm	207 (25.2) 478 (58.1) 137 (16.7)	8 (57.1) 6 (42.9) 0 (0.0)	0.005
Pancreatic duct stent	47 (5.7)	2 (14.3)	0.195
Angulation of bile duct (> 145°)	52 (6.3)	1 (7.1)	0.603
Biliary stent length, cm < 7 ≥ 7	410 (49.9) 412 (50.1)	8 (57.1) 6 (42.9)	0.946
Duodenal diverticula	68 (8.3)	5 (35.7)	0.002
Cholecystectomy	254 (30.9)	3 (21.4)	0.446
Post-gastrectomy	15 (1.8)	1 (7.1)	0.238
Biliary stent type Christmas tree-shaped stent Common plastic stent	79 (9.6) 743 (90.4)	1 (7.1) 13 (92.9)	0.247
Cystic duct diameter, mm < 8 ≥ 8	370 (45.0) 452 (55.0)	4 (28.6) 10 (71.4)	0.220

BMI, body mass index; EST, endoscopic papillary sphincterotomy; EPBD, endoscopic papillary balloon dilatation.

Table 4

Logistic regression analyses of the risk factors for stent displacement after stone removal with endoscopic retrograde cholangiopancreatography
Risk factors	OR (95% CI)	P value
Age	1.032 (0.988–1.078)	0.157
Duodenal diverticulum	6.412 (2.010-20.451)	0.002
EPBD (> 1 cm)	2.708 (1.196–3.243)	0.043

OR, odds ratio; CI, confidence interval; EPBD, endoscopic papillary balloon dilatation.

All enrolled patients underwent successful removal of bile duct stones by ERCP in a single procedure. The incidence of postoperative adverse events such as pancreatitis, biliary tract infection, and biliary tract hemorrhage did not differ significantly between the early migration group and the non-migration group, as shown in Table 5.

Table 5

Occurrence of complications in the plastic stent migration and no-migration groups after stone removal with endoscopic retrograde cholangiopancreatography
Complications	No-migration group (n = 731)	Migration group (n = 105)	P value
Complications	166/565 (29.4%)	20/85 (23.5%)	0.399

Biliary stones are the leading cause of hospitalization for gastrointestinal diseases worldwide^{[5]. In the United States, approximately 20 to 25 million individuals (10% to 15% of the adult population) show gallstones}^{[6], and gallstone disease accounts for the highest proportion of medical expenses ($4.3 billion)}^{[7]. The incidence of cholelithiasis in China, Japan, South Korea, and other Asian countries is significantly higher than that in Western countries due to the substantial improvement in living standards and changes in dietary structure in recent years, and their incidence continues to increase in these countries}^[8].With advancements in endoscopic minimally invasive techniques and related accessory instruments, ERCP combined with sphincterotomy and stone removal is the first choice for the treatment of CBD stones. It can successfully remove CBD stones in up to 90% of patients, with the advantages of less trauma^{[9], fewer adverse events, and rapid postoperative recovery. However, incision of the papillary sphincter, balloon compression, and repeated stone stimulation during the operation can cause obvious edema of the mucosa around the nipple, which can induce acute cholangitis and pancreatitis. Therefore, in order to ensure the stability of postoperative drainage of bile and pancreatic juice, endoscopic nasobiliary drainage (ENBD) or endoscopic biliary plastic stent placement (ERBD) is often performed for drainage. ERBD and ENBD have both been shown to have unique advantages and disadvantages in bile drainage, with no significant differences in efficacy and adverse events}^[10]^{[11]. ENBD is a form of external drainage, which is associated with substantial bile loss and can cause great discomfort to patients after the operation. Therefore, patients are increasingly choosing postoperative biliary plastic stent implantation for short−term full drainage of the bile. However, biliary stent displacement has been reported to occur in 5%−10% of patients undergoing endoscopic biliary stent placement}^[12]^{[13]. Our study showed that the rate of stent displacement after ERCP for bile duct stones was approximately 12.6%, slightly higher than that reported previously. This may be related to the fact that our study population mainly included patients who had undergone ERCP for removal of bile duct stones, and did not include patients with benign or malignant biliary stenosis.}Some studies have reported early displacement of biliary stents, and biliary plastic stents that migrate to the intestine can cause intestinal perforation in rare cases, which is related to intestinal structural abnormalities or variations such as postoperative intestinal adhesion, colonic diverticulum, and hernia^[14]^{[15]. However, the factors influencing biliary stent migration from the CBD to the middle and upper segments of common bile duct and distal intestine have not been adequately studied in the existing literature. The results from this study show that incision of the duodenal papillary sphincter, presence of diverticula at the nipple, and the length and type of biliary stent are independent risk factors for early migration of biliary plastic stents. Therefore, patients with CBD stones and these characteristics are at a high risk of showing stent displacement and other related potential adverse events during ERCP and postoperative follow−up assessments. The appearance of abdominal pain indicates the need for caution and measures to prevent the occurrence of adverse consequences. According to previous studies}^{[16], the probability of intestinal perforation caused by displacement of long stents and Christmas tree−shaped stents is high, so these stents should be selected only after sufficient consideration. For the high−risk population, nasobiliary biliary drainage can be considered during ERCP or the patient can be instructed to return to the hospital as soon as possible for removal of the biliary plastic stent. Our study showed that although 91 patients showed early displacement of biliary plastic stents to the intestinal cavity during the follow−up period, all of these stents were successfully discharged from the intestinal cavity without causing obvious adverse reactions during the follow−up period.}Similarly, 14 patients in this study showed displacement of biliary plastic stents. In addition to the acute cholangitis and biliary stent obstruction caused by stent retention in the bile duct, adherence of bile mud to the stent leads to re-formation of bile duct stones. The results of this study show that the presence of diverticula at the nipple and the degree of balloon dilatation are independent risk factors for inward migration of biliary plastic stents, and that abnormal structures around the duodenal papilla increase the risk of biliary stent displacement. Therefore, in patients with diverticula at the nipple of the descending duodenum and those requiring balloon dilatation of the papillary sphincter and the lower bile duct for stone removal, if the biliary plastic stent is placed after the operation, the patient should return to the hospital as soon as possible for removal of the biliary plastic stent to avoid inward displacement of the biliary plastic stent. Simultaneously, once the plastic stent is displaced, prompt removal of the stent displaced to the bile duct under ERCP is essential.

This study also had some limitations. Since this was a single-center retrospective study, accurate control of the time of biliary stent removal in the outpatient department was impossible, which may have influenced the time of accurate assessment of stent displacement. Moreover, some patients who were lost to follow-up, and the influence of these missing data on the results could not be determined. Therefore, we plan to conduct a multi-center, large-sample prospective controlled study to further evaluate the factors influencing early migration of biliary plastic stents after ERCP lithotomy.

Displacement of plastic biliary stents occurs frequently during the treatment of patients with ERCP. Therefore, for patients with a duodenal papillary diverticulum who require large balloon dilation during stone removal with ERCP, nasobiliary stent placement can be performed to avoid early internal displacement of the biliary plastic stent and maximize the beneficial outcomes.

ERCP：Endoscopic Retrograde Cholangiopancreatography；ERBD：Endoscopnic Bile Duct Plastic Stent Placement；ENBD：Endoscopic Nasobiliary Drainage；EPBD：Endoscopic Papillary Balloon Dilatation；EST：Endoscopic Sphincterotomy；

CBD：Common Bile Duct；CT：Computed tomography；MRCP：Magnetic Resonance Cholangiopancreatography；CRP：C-reactionprotein

Ethics approval and consent to participate: This study was approved by the Ethics Committee of 900TH Hospital of PLA. All methods of this study were performed in accordance with the Declaration of Helsinki.

Consent for publication: Not applicable.

Authors’ Contributions: Longping Chen, Yanfang Lin, Linfu Zheng, Chuan-Shen Jiang, Zhiping Chen, Da-Zhou Li, Wen Wang participated in the acquisition of data;

Longping Chen, Yanfang Lin, Linfu Zheng contributed to the manuscript drafting; Longping Chen, Chuan-Shen Jiang, Zhiping Chen, Da-Zhou Li and Wen Wang contributed to the analysis and interpretation of data, as well as revise of the manuscript for important intellectual content

Acknowledgements: Not applicable.

Availability of data and material: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Disclosures：Longping Chen, Yanfang Lin, Linfu Zheng, Chuan-Shen Jiang, Zhiping Chen, Da-Zhou Li, Wen Wang have no potential conflicts of interest or financial ties to disclose.

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No competing interests reported.

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You are reading this latest preprint version

Characteristics of and risk factors for early migration of biliary plastic stents after stone removal with endoscopic retrograde cholangiopancreatography

Status:

Version 1

Abstract

Figures

Introduction

Materials and Methods

Patients

Endoscopic system

ERCP procedure

Follow-up procedure

Adverse events after ERCP

Early migration of biliary plastic scaffolds

Statistical analysis

Results

Discussion

Abbreviations

Declarations

References

Additional Declarations

Status:

Version 1