Retained biliary plastic stents

Abstract

Prolonged indwelling of endoscopically placed biliary plastic stents may lead to complications. We conducted a retrospective analysis of patients who underwent endoscopic retrograde cholangio-pancreaticography (ERCP) at our centre in 2017 and were noted to have retained biliary plastic stents ( > 3 months after an index ERCP). A total of 127 patients had previously placed biliary plastic stents, out of which 45 (35.4%) were retained. The median age of the latter was 52 years (range = 22–79 years) with 27 (60%) patients being men. The median duration of the retained stents was 144 days (range = 94–3292 days). The majority of the patients were asymptomatic. However, 9 (20%) patients had cholangitis, 2 (4.4%) had choledocholithiasis, 2 (4.4%) had cholangitic abscess and 1 (2.2%) developed septicaemia. Fortunately, all these complications could be managed medically and endoscopically. Retention of biliary plastic stents is a problem often overlooked and underestimated in clinical practice. Various measures need to be instituted to create awareness of this entity to prevent undesirable outcomes.

Keywords

Endoscopy ERCP biliary stenting complications

Introduction

Endoscopic biliary stenting after an endoscopic retrograde cholangio-pancreaticography (ERCP) is the commonest method for relieving extra-hepatic biliary obstruction (EHBO) of any cause.^1,2 Although both plastic and metal stents are effective in providing biliary drainage, stent occlusion is an issue that can occur with the passage of time, more so with the former.³ Biliary plastic stents are recommended to be removed or exchanged within three months of their deployment as their retention may lead to complications such as cholangitis, stent breakage, stent migration, choledocholithiasis, etc.^4–8

Unfortunately, retention of biliary plastic stents is a problem that is seldom reported. Even in a country such as India, where there are good number of centres performing therapeutic ERCP, available literature on this topic is meagre.⁹ Considering the expansion of therapeutic ERCP services to many regions worldwide, it is imperative that the possibility of neglected biliary plastic stents be highlighted. The aim of the present study was to assess the burden of this entity in our hospital, a major tertiary care centre in south India, and in particular the possible reasons for failure to remove such stents.

Methodology

Ours was a retrospective study of all patients with retained biliary plastic stents among those who had undergone ERCP in our centre between 1 January and 31 December 2017. Data regarding clinical profile and associated complications were obtained from the hospital database. We defined retention of the stent as a delay in removal >3 months after insertion.

Exclusion criteria were as follows: patients undergoing ERCP for the first time; patients with biliary metal stents in situ; where pancreatic stenting was performed; where cannulation had failed; and children aged < 15 years (Figure 1).

Figure 1.

Flow diagram.

Outpatient and inpatient medical records and related reports were reviewed in detail. Relevant demographic, clinical information (i.e. presenting symptoms, laboratory parameters, radiology reports, complications, etc.) and ERCP details (i.e. type of biliary pathology, indication for stenting, length and diameter of stents used) were documented. Data were also collected regarding endoscopic, radiologic or surgical management of these patients as well as their clinical course. We also tried to identify possible reasons for failure of removal of the retained stents.

Categorical variables were presented as frequency (percentages) while continuous variables were presented as mean ± standard deviation or as median (range).

The study was approved by the Institutional Review Board (Silver, Research and Ethics Committee), Christian Medical College, Vellore (Ref: IRB:12343 [Retro] dated 30 October 2019).

Results

A total of 471 patients underwent ERCP during the study period, out of whom 127 had a biliary plastic stent in situ (Figure 1). Among the latter, 45 (35.4%) had retained stents. These were included in our study. There were 27 (60%) men and the median age was 52 years (range = 22–79 years).

Stent placement was undergone by 27 (60%) patients in our hospital and by 18 (40%) patients elsewhere. Indications for initial stent placement were failed common bile duct (CBD) clearance in 9 (20%), benign CBD stricture in 18 (40%), malignant CBD stricture in 8 (17.8%), cholangitis in 7 (15.6%), bile leak in 1 (2.2%) and other reasons in 2 (4.4%).

The majority, 31 (68.9%), were asymptomatic, but 10 (22.2%) had fever and 9 (20%) reported jaundice, while 8 (17.8%) had abdominal pain. The mean ± SD values of total bilirubin, direct bilirubin, AST, ALT and alkaline phosphatase in the study population were 39.67 ± 59.51 μmol/L, 28.73 ± 52.16 μmol/L, 44.59 ± 33.67 U/L, 44.89 ± 44.42 U/L and 268.41 ± 241.71 U/L, respectively.

Complications attributed to the presence of retained biliary plastic stents included cholangitis in 9 (20%) patients, choledocholithiasis in 2 (4.4%) patients, cholangitic abscess in 2 (4.4%) patients and septicaemia in 1 (2.2%) patient.

Overall, the median duration of retained biliary plastic stents was 144 days (range = 94–3292 days). The median duration of stent in situ for those who presented with cholangitis was 143 days (range = 107–2624 days) while for those who developed choledocholithiasis it was 82.4 months (range = 55–109.7 months).

Endoscopic procedures performed during repeat endoscopy for retained biliary stent included stone removal in 8 (17.8%) patients, stent removal in 18 (40%) patients, stent exchange in 23 (51.1%) patients and additional stent placement in 3 (6.7%) patients.

A total of 18/45 (40%) patients required further endoscopy sessions, of whom 11 underwent an additional session, while seven had two or more sessions.

Retention of the biliary stent caused 15 (33.3%) patients to stay in hospital owing to complications for a median duration of 3 days (range = 2–16 days). Fortunately, there was no need for surgery, radiologic intervention, admission to the intensive care unit or mortality in our study group.

Among the 27 patients who underwent initial stent placement in our hospital, 9 (33.3%) did not have documentation of a clear plan for biliary stent removal, and in 17 (63%) patients, more than one clinical department was involved in their care.

Discussion

Biliary plastic stents are used to decompress the biliary system in benign and malignant biliary conditions. They provide temporary or alternate measures of biliary drainage for patients who are unfit for surgery but need removal or exchange within three months of insertion.^1,4,10 A longer duration is associated with complications. Stent occlusion and migration are the major complications that occur. Occlusion occurs due to a gradual accumulation of bacterial biofilm and sludge.^11,12 The mean duration of biliary plastic stent patency is in the range of 2.7–7.8 months for benign diseases and 1.8–5.7 months for malignant biliary diseases.^11,13–15 Biliary plastic stents are associated with stent-related cholangitis in 8%–40% of patients.^16–18 Mortality in patients with stent-related cholangitis is as high as 6.7% among those who received long-term biliary stenting for choledocholithiasis.¹⁶ To prevent the risk of stent obstruction and other associated morbidities, experts and international guidelines advise selective endoscopy to remove or replace biliary plastic stents within three months of their initial insertion.^1,4,5,18,19

All our patients were managed medically and endoscopically with success. The initial stenting was done in hospitals elsewhere in 40% of our patients. Kumar at al., in their series, reported that 15 (71.4%) patients had undergone biliary plastic stenting at other centres.⁹ When patients are part of a healthcare system without centralized or a shared endoscopic database, there is a good chance that information may not be adequately conveyed to both patients and the subsequent treating team with regard to the need for biliary plastic stent removal or exchange within the stipulated time period. Within our own centre, we identified two possible reasons, inadequate documentation about the time frame for stent removal and the involvement of multiple related specialties (medical and surgical) in patient care; miscommunication and lack of understanding among patients being the culprits.

As ours was a retrospective study, we could not accurately capture the influence of other factors such as remoteness of a patient's domicile, financial constraints, patient convenience, personal preference, language barrier, level of education, patient unawareness, lack of social support, deficiency in counselling, etc. on the delay in stent removal. We feel these factors need to be part of a prospective study.

Short message service (SMS) reminders and telephone calls could significantly increase patient adherence.^9,19 However, awareness among endoscopists themselves and their units, together with a stent registry system, are virtually mandatory.

The prevalence of retained plastic biliary stent appears to be significant. Although none of our patients required surgical intervention or admission to the intensive care unit, this may not be the case elsewhere.

Important limitations of our study are its retrospective nature and being confined to a single centre. We acknowledge that rigid recommendation of three-monthly removal of plastic stents may result in asymptomatic patients being subjected to more frequent endoscopy procedures with their attendant risks, expenditure and inconvenience. Further studies would need to be done to derive more exact cut-off times, but retained biliary plastic stents will continue to give problems if they are not appropriately addressed.

Footnotes

Acknowledgements

The authors thank Abhishek Jain, Reuben T Kurien, Amit K Dutta and AJ Joseph for their support towards the conduct of the study.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

Ebby G Simon

References

Perri

Familiari

Tringali

, et al. Plastic biliary stents for benign biliary diseases. Gastrointest Endosc Clin N Am 2011; 21: 405–433.

de C Ferreira

LEVV

Baron

. Endoscopic stenting for palliation of malignant biliary obstruction. Expert Rev Med Devices 2010; 7: 681–691.

Moss

Morris

Leyden

, et al. Do the benefits of metal stents justify the costs? A systematic review and meta-analysis of trials comparing endoscopic stents for malignant biliary obstruction. Eur J Gastroenterol Hepatol 2007; 19: 1119–1124.

Dumonceau

J-M

Tringali

Papanikolaou

, et al. Endoscopic biliary stenting: indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated October 2017. Endoscopy 2018; 50: 910–930.

Chathadi

Chandrasekhara

Acosta

, et al. The role of ERCP in benign diseases of the biliary tract. Gastrointest Endosc 2015; 81: 795–803.

Bagul

Pollard

Dennison

. A review of problems following insertion of biliary stents illustrated by an unusual complication. Ann R Coll Surg Engl 2010; 92: e27–31.

Odabasi

Arslan

Akbulut

, et al. Long-term effects of forgotten biliary stents: a case series and literature review. Int J Clin Exp Med 2014; 7: 2045–2052.

Grossen

Magguilli

Thai

, et al. Hepatic actinomycosis in a patient with retained common bile duct stent. ACG Case Rep J 2019; 6: e00219.

Kumar

Chandra

Kulkarni

, et al. Forgotten biliary stents: ignorance is not bliss. Surg Endosc 2018; 32: 191–195.

10.

Khashab

Kim

Hutfless

, et al. Predictors of early stent occlusion among plastic biliary stents. Dig Dis Sci 2012; 57: 2446–2450.

11.

Leung

JWC

Ling

TKW

Kung

JLS

, et al. The role of bacteria in the blockage of biliary stents. Gastrointest Endosc 1988; 34: 19–22.

12.

Costa

Bracco

Vada

, et al. A chemical analysis of the clogging process of polymeric biliary endoprostheses. Biomaterials 2001; 22: 3113–3119.

13.

De Palma

Galloro

Siciliano

, et al. [Results of the use of endoprostheses in the treatment of retained common bile duct stones]. Minerva Chir 2000; 55: 823–827.

14.

Soderlund

Linder

. Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Gastrointest Endosc 2006; 63: 986–995.

15.

Walter

van Boeckel

PGA

Groenen

, et al. Cost efficacy of metal stents for palliation of extrahepatic bile duct obstruction in a randomized controlled trial. Gastroenterology 2015; 149: 130–138.

16.

Pisello

Geraci

Li Volsi

, et al. Permanent stenting in “unextractable” common bile duct stones in high risk patients. A prospective randomized study comparing two different stents. Langenbecks Arch Surg 2008; 393: 857–863.

17.

Bergman

Rauws

Tijssen

, et al. Biliary endoprostheses in elderly patients with endoscopically irretrievable common bile duct stones: report on 117 patients. Gastrointest Endosc 1995; 42: 195–201.

18.

Lawrence

Romagnuolo

Payne

, et al. Low symptomatic premature stent occlusion of multiple plastic stents for benign biliary strictures: comparing standard and prolonged stent change intervals. Gastrointest Endosc 2010; 72: 558–563.

19.

Wang

Zhao

, et al. Effect of mobile phone reminder messages on adherence of stent removal or exchange in patients with benign pancreaticobiliary diseases: a prospectively randomized, controlled study. BMC Gastroenterol 2016; 16: 105.

Retained biliary plastic stents – lest we forget