ABSTRACT
Background
Post‐endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) occurs in up to 10% of cases. Prophylactic pancreatic stenting reduces PEP risk; however, plastic stents frequently require an additional procedure for removal, increasing cost and patient burden. Biodegradable pancreatic stents negate the need for retrieval, but data on cost‐effectiveness and clinical outcomes remain limited.
Methods
We conducted a two‐center retrospective cohort study of adults undergoing ERCP with biodegradable pancreatic stent placement for PEP prophylaxis between January 2021 and August 2025. Demographic, procedural, and clinical data were collected. The primary outcome was per‐patient cost difference between patient journeys utilizing biodegradable and plastic stenting. Secondary outcomes included PEP incidence, technical success, and stent usability data.
Results
A total of 5086 ERPCs were performed during the study period, and 111 ERCPs with biodegradable stents inserted were analyzed (mean age 62 years; 57% female; 39% rural). Technical success was 98%. The mean cost difference per patient favored biodegradable stents by AUD$393 (95% CI 149–63, p = 0.002). PEP occurred in 11% (12/111), all of which were mild. Higher rates of PEP were noted in patients on anticoagulation (36% vs. 8%, p = 0.02), with a history of prior PEP (67% vs. 8%, p = 0.02), or with failed pancreatic stent placement (100% vs. 9%, p = 0.01). Endoscopists rated ease of use comparable to plastic stents.
Conclusion
Biodegradable pancreatic stent placement is technically safe, effective, and associated with significant cost savings and reduced patient/healthcare burden by negating the need for further procedures. Observed PEP rates were consistent with those reported in high‐risk cohorts.
Keywords: biodegradable pancreatic stent, endoscopic retrograde cholangiopancreatography, pancreatic duct stenting, post ERCP pancreatitis, post‐endoscopic retrograde cholangiopancreatography pancreatitis
Abbreviations
- ASA
American Society of Anesthesiologists
- BMI
body mass index
- CBD
common bile duct
- ERCP
endoscopic retrograde cholangiopancreatography
- LT
liver transplant
- PD
pancreatic duct
- PEP
post ERCP pancreatitis
- SOD
sphincter of Oddi dysfunction
1. Introduction
Post‐endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) occurs in up to 10% of ERCP procedures and incurring a mortality of up to 1% [1]. Pancreatic stenting reduces the rate of PEP in high‐risk procedures by about 4% [2]. Important patient risk factors include female sex, history of prior PEP and suspected sphincter of Oddi dysfunction [3]. Procedural factors such as difficult biliary cannulation, pancreatic duct cannulation and pancreatic duct contrast injection also increase the risk [4, 5, 6]. Pancreatic duct stenting with a plastic stent, although effective and widely used, is laborious as it requires follow‐up imaging and endoscopic removal, usually within 1–2 weeks if the stent remains in situ [5]. The literature regarding spontaneous passage of pancreatic stents when placed for prophylaxis ranges from 26% to 84% [7, 8]. The centers in this study have a repeat gastroscopy rate for plastic pancreatic stent removal of 67%. Failure to remove the stent may lead to duct stricture and subsequent chronic pancreatitis [9, 10]. Biodegradable pancreatic stents have recently become available with some early cost benefit studies suggesting cost effectiveness in comparison to conventional plastic pancreatic stenting. However, the evidence on the efficacy of biodegradable pancreatic stenting in reducing PEP compared to conventional pancreatic stenting is limited. In addition, one important limitation to highlight is that cost‐effectiveness is closely related to the country/healthcare system the study has taken place and is not often easily translatable to other countries.
The fast‐degrading Archimedes (Q3 Medical, Dublin, Ireland) pancreatic stent is made of a biodegradable polymer formed into a helical structure allowing for pancreatic fluid flow, while maintaining duct patency during the degradation process.
The primary aim of this study is to assess the cost difference in patient journeys comparing placement of a biodegradable pancreatic to the cost of placing a plastic pancreatic stent (and estimated further costs associated with its monitoring and potential endoscopic removal). Secondary outcomes include evaluating the technical feasibility, ease of use and the impact of patient and procedure‐related factors on clinical outcomes.
2. Methods
This was a two‐center retrospective cohort study conducted across Australia and New Zealand, including consecutive adult patients where a 6Fr, 4 cm fast‐degrading biodegradable pancreatic stent as shown in Figures 1 and 2, was placed during ERCP with the indication of reducing pancreatitis in a high‐risk procedure between January 2021 and August 2025. Data were collected using a standardized collection form, ensuring anonymization of participant information. A survey was sent to all eight endoscopists involved in the study and data collected were anonymized. Investigators at both sites reviewed medical records, procedural details and patient characteristics. Difficult biliary cannulation was defined as a cannulation attempt lasting > 5 min, more than five attempts or two pancreatic guidewire passages as per ESGE guidelines [5]. Indomethacin was administered to all patients without prior history of sphincterotomy unless contraindicated due to allergy or creatinine clearance < 30 mL/min. Being teaching hospitals, all ERCP procedures in both centers were at least initially performed by a fellow under direct supervision of a consultant interventional endoscopist. Standard protocol for patients receiving plastic pancreatic stents at these centers includes repeat endoscopic removal scheduled at 1–2 weeks post procedure with an abdominal X‐ray prior to procedure to ascertain need for removal.
FIGURE 1.
Archimedes biodegradable pancreatic stent. Archimedes, Q3 Medical Group, Dublin, IRL.
FIGURE 2.
Endoscopic image of biodegradable pancreatic stent.
3. Ethical Considerations
This study was approved by the Health Human Research Ethics Committee of Victoria Translational Research Institute under the reference number HREC/111674/Austin‐2024 with site specific authorization approval at the New Zealand Center. It was conducted in accordance with the ethical standards of the institutional research committee and the principles outlined in the Declaration of Helsinki. As this was a retrospective study using anonymized clinical data, individual informed consent was waived, with appropriate privacy protections in place.
4. Statistical Analyses
Continuous variables were summarized as means with standard deviations or medians with ranges, depending on the distribution, which was assessed using the Shapiro–Wilk test. Categorical variables were expressed as counts and percentages. Differences between categorical variables were analyzed using Pearson's chi‐squared test or Fisher's exact test when expected frequencies were below five. For continuous variables, independent samples t‐tests were used for normally distributed data, while Mann–Whitney U tests were applied for non‐normally distributed data. Univariable logistic regression was performed to assess associations between potential risk factors and binary outcomes with results reported as odds ratios (ORs) and 95% confidence intervals (CIs). Linear regression was used to examine associations between predictor variables and continuous outcomes.
A p‐value of < 0.05 was considered statistically significant. All analyses were conducted using SPSS version 27 (IBM Corp., Armonk, NY).
5. Results
A total of 111 ERCP procedures with biodegradable pancreatic stent placement for PEP prophylaxis were included across two tertiary centers in Australia and New Zealand; this was 2% of the total ERCP procedures carried out in the study timeframe. The mean age was 62 years (SD 17.4) and 57% were female. Rural residence was documented in 39% of cases. Detailed demographic data are presented in Table 1. Primary indication for pancreatic stent placement was difficult biliary cannulation in 79% of cases (Table 2).
TABLE 1.
Patient and procedural characteristics.
| Patient characteristics | |
| Mean age, year (SD) | 62 (17.4) |
| Female, n (%) | 63 (57) |
| Resides in rural region, n (%) | 43 (39) |
| Anticoagulant use, n (%) | 11 (10) |
| Antiplatelet use, n (%) | 33 (30) |
| BMI > 30, n (%) | 2 |
| ASA classification, n (%) | |
| 1 | 15 (14) |
| 2 | 40 (36) |
| 3 | 50 (45) |
| 4 | 6 (5) |
| Procedural characteristics | |
| Intact ampulla, without prior sphincterotomy | 96 (87%) |
| Difficult biliary cannulation (%) | 95 (85) |
| Post ERCP adverse events, n (%) | 15 (14) |
| Post sphincterotomy bleeding | 1 |
| Cholangitis | 2 |
| Pancreatitis | 12 |
| Technical success of biodegradable pancreatic stent placement, n (%) | 109 (98) |
Abbreviations: ASA: American Society of Anesthesiologists; BMI: Body mass index.
TABLE 2.
Indications for pancreatic stent placement.
| Indications for pancreatic stent placement | |
|---|---|
| Difficult biliary cannulations, n (%) | 88 (79%) |
| Inadvertent PD cannulation (not meeting criteria for difficult biliary cannulation), n (%) | 12 (11%) |
| Ampullectomy procedure, n (%) | 5 (5%) |
| Treatment of ampullary adenoma recurrence, n (%) | 6 (5%) |
5.1. Cost Assessment
The mean cost of initial ERCP with biodegradable pancreatic stent placement was AUD$5442 compared to AUD$3887 for ERCP and plastic pancreatic stenting. A detailed breakdown of individual cost components for the ERCP procedure is provided in Table S1. The cost of repeat imaging and endoscopy for plastic stent removal at our center is AUD$2854, while the cost of repeat imaging alone to assess for stent passage is AUD$112. A detailed breakdown of individual cost components for the pancreatic stent removal procedure is provided in Table S2. Based on the rate of plastic stent removal of 67% at our center, there was a mean difference of AUD$393 per patient (95% CI 149–637, p = 0.002) in favor of biodegradable pancreatic stent placement. This equates to a cost saving of AUD$20436 per year with the rate of all stents placed for PEP prophylaxis per year in these centers (52).
5.2. Procedural Outcomes
Among the ERCP procedures, 87% were performed on ampullas without prior sphincterotomy. Indomethacin was administered to 104/111, 91 ampullae without prior sphincterotomy, three with a prior history of post ERCP pancreatitis, two in patients with sphincterotomies with evidence of prior small or incomplete sphincterotomy, and eight in patients where ampullary adenoma treatment occurred. The most common indication for ERCP was choledocholithiasis (Table 3).
TABLE 3.
Indications for ERCP procedure.
| Indications for ERCP | Number |
|---|---|
| Ampullary adenoma surveillance | 7 |
| CBD stones | 55 |
| Malignant biliary obstruction | 19 |
| Non‐malignant biliary stricture | 4 |
| Ampullectomy for ampullary adenoma | 4 |
| Bile leak | 12 |
| LT anastomotic stricture | 4 |
| Suspected SOD | 5 |
| Cholangitis | 1 |
Abbreviations: CBD: common bile duct; LT: liver transplant; SOD: sphincter of Oddi dysfunction.
Pancreatic stent placement was successful in 98% of procedures. PEP occurred in 11% (12/111), all classified as mild according to revised Atlanta Criteria [11]. PEP was significantly higher in those on anticoagulation (36% vs. 8%, p = 0.02) and in those with a prior history of PEP (67% vs. 8%, p = 0.02). Both patients (100%) in whom pancreatic stent placement failed developed pancreatitis (p = 0.01) (Table 4).
TABLE 4.
Univariate analysis of characteristics association between post ERCP pancreatitis.
| PEP | p | |
|---|---|---|
| Sex | 0.5 | |
| Male | 5 (10%) | |
| Female | 7 (11%) | |
| BMI | 0.41 | |
| > 30 | 4 (13%) | |
| < 30 | 8 (9.8%) | |
| Anticoagulant use | 0.02 | |
| Yes | 4 (36%) | |
| No | 8 (8%) | |
| Prior PEP | 0.02 | |
| Yes | 2 (67%) | |
| No | 1 (8%) | |
| Difficult biliary cannulation | 0.42 | |
| Yes | 11 (12%) | |
| No | 1 (6%) | |
| Successful PD stent placement | 0.01 | |
| Yes | 10 (9%) | |
| No | 2 (100%) |
5.3. Endoscopist Survey on Biodegradable Pancreatic Stent Use and Stent Usability
Among the endoscopists involved in this study, 75% (6/8) reported that biodegradable pancreatic stents are their preferred choice for post‐ERCP pancreatitis prophylaxis. The remaining 25% (2) reserve the use of biodegradable stents primarily for patients living in rural areas due to the need for repeat procedures. All endoscopists rated the ease of stent insertion as comparable to that of plastic pancreatic stents.
The stents were rated as good or excellent in terms of loadability (88%), pushability (100%), flexibility (63%), and deployment accuracy (88%). However, 63% (5/8) of endoscopists rated the fluoroscopic visualization of the biodegradable stent as fair or poor.
6. Discussion
This two‐country retrospective study demonstrates that biodegradable pancreatic stent placement during ERCP is associated with significant cost savings compared with conventional plastic pancreatic duct stents. The principal advantage of biodegradable stents is the elimination of the need for repeat imaging or endoscopic removal, resulting in a cost saving of $393 per patient, based on the 67% of plastic stents requiring removal over the 5‐year study period. Beyond direct procedural costs, biodegradable stents provide additional benefits to both patients and the healthcare system, including reduced demand for radiology and endoscopy services and avoidance of complications associated with retained stents. Among 128 plastic stents placed during the study period, 4.7% (6) were not retrieved due to inadequate follow‐up, with one patient readmitted 6 months later with pancreatitis secondary to a retained stent. The present cost analysis did not account for several indirect factors that would further favor biodegradable stents, such as travel costs for repeat procedures (partly reimbursed by government schemes in Australia and New Zealand), time away from work, and broader quality‐of‐life implications for patients. Therefore, the actual cost minimization achieved through biodegradable stent use is likely underestimated in this study.
There are limited studies on the cost‐effectiveness of biodegradable versus plastic pancreatic stent placement, most of which are abstracts. One abstract published with 68 patients proposed similar costs between plastic and biodegradable which also accounted for travel costs, however the rate of spontaneous passage of plastic stent is higher than found at our Center's [12]. Another UK study of 60 patients showed a GBP 361 benefit in favor of biodegradable pancreatic stent, however cost benefit analysis carried out in this study was unusual given that the clinical outcomes of pancreatic and biodegradable pancreatic stent placements are similar [13]. There are no published original articles showing cost difference between the two stents to date.
The observed PEP rate in our study of 11% is in keeping with the known rates of PEP in the literature particularly in this high‐risk group with difficult biliary cannulation and inadvertent pancreatic duct cannulation [14]. Importantly, no moderate or severe cases occurred. Technical success of biodegradable pancreatic stent placement was high at 98% consistent with prior studies of pancreatic stent placement [7, 8, 15]. In addition to the similar technical success, endoscopists rated its ease of use similar to that of plastic pancreatic stent placement; however, fluoroscopic visualization of the stent was found to be less favorable.
This study has several limitations to be acknowledged. Its retrospective nature introduced potential selection bias with the selection of patients where biodegradable pancreatic stents are placed in place of conventional pancreatic stents. However, it is standard practice for most endoscopists for the past few years to always use biodegradable pancreatic stents for PEP prophylaxis based on preliminary data from this cohort and other corroborating data from around the world. The sample size, while larger than any previous reports of biodegradable pancreatic stent placement, is still limited when assessing the true incidence of PEP in this group.
The cost analysis was based on the average cost of procedures carried out at the Australian site and therefore may only be directly applicable to our cohort. However, similarly to the kinship between the public sector health systems between Australia and New Zealand, other health systems might be substantially comparable and can probably trace a parallel to our findings [16].
A key limitation of this study is the lack of a direct comparison group using plastic stents, which limits definitive conclusions regarding relative efficacy in reducing PEP and different healthcare models and costs.
In conclusion, biodegradable pancreatic stents appear cost‐effective for PEP in high‐risk ERCP procedures across our cohort; however, larger prospective comparative studies are required to confirm our findings.
Funding
The authors have nothing to report.
Consent
No written consent has been obtained from the patients as there is no patient.
Conflicts of Interest
The authors declare no conflicts of interest.
Supporting information
Table S1: Table describing breakdown of cost for ERCP procedure.
Table S2: Table describing breakdown of cost for gastroscopy procedure and plastic stent removal.
Data Availability Statement
The data supporting the findings of this study are available within the article and its Supporting informations. Detailed cost breakdowns used for the cost analysis are provided in the supplementary tables. Additional data are available from the corresponding author upon reasonable request.
References
- 1. Banks P. A., Bollen T. L., Dervenis C., et al., “Classification of Acute Pancreatitis—2012: Revision of the Atlanta Classification and Definitions by International Consensus,” Gut 62, no. 1 (2013): 102–111, 10.1136/gutjnl-2012-302779. [DOI] [PubMed] [Google Scholar]
- 2. Elmunzer B. J., Foster L. D., Serrano J., et al., “Indomethacin With or Without Prophylactic Pancreatic Stent Placement to Prevent Pancreatitis After ERCP: A Randomized Noninferiority Trial,” Lancet (London, England) 403, no. 10425 (2024): 450–458, 10.1016/S0140-6736(23)02356-5. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3. Chen J. J., Wang X. M., Liu X. Q., et al., “Risk Factors for Post‐ERCP Pancreatitis: A Systematic Review of Clinical Trials With a Large Sample Size in the Past 10 Years,” European Journal of Medical Research 19, no. 1 (2014): 26, 10.1186/2047-783X-19-26. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 4. Thaker A. M., Mosko J. D., and Berzin T. M., “Post‐Endoscopic Retrograde Cholangiopancreatography Pancreatitis,” Gastroenterol Report 3, no. 1 (2015): 32–40, 10.1093/gastro/gou083. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5. Dumonceau J. M., Andriulli A., Elmunzer B. J., et al., “Prophylaxis of Post‐ERCP Pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline—Updated June 2014,” Endoscopy 46 (2014): 799–815, 10.1055/s-0034-1377875. [DOI] [PubMed] [Google Scholar]
- 6. Ghalehnoei H., Hormati A., Mohammad Alizadeh A. H., Ahmadpour S., and Abedi S. H., “Patient‐Related Post‐ERCP Pancreatitis (PEP) Risk Factors Between Two Groups of Patients: Prophylactic Pancreatic Stent and Rectal Indomethacin,” Caspian Journal of Internal Medicine 13, no. 4 (2022): 728–734, 10.22088/cjim.13.4.728. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7. Paspatis G., Psaroudakis I., Velegraki M., et al., “Effectiveness of Prophylactic Pancreatic Stents in Preventing Post‐Endoscopic Retrograde Cholangiopancreatography Pancreatitis in High‐Risk Patients: A 16‐Year Comprehensive Study,” Annals of Gastroenterology 38, no. 5 (2025): 570–576, 10.20524/aog.2025.0996. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8. Gromski M. A., Dey N. D., Wang B., et al., “S65 Spontaneous Migration of Pancreatic Stents Placed for Post‐ERCP Pancreatitis Prophylaxis: Rates and Time to Migration,” Official Journal of the American College of Gastroenterology| ACG 118, no. 10S (2023): S55, 10.14309/01.ajg.0000949900.28837.c3. [DOI] [Google Scholar]
- 9. Rashdan A., Fogel E. L., McHenry L., Sherman S., Temkit M., and Lehman G. A., “Improved Stent Characteristics for Prophylaxis of Post‐ERCP Pancreatitis,” Clinical Gastroenterology and Hepatology 2, no. 4 (2004): 322–329, 10.1016/S1542-3565(04)00062-X. [DOI] [PubMed] [Google Scholar]
- 10. Smith M. T., Sherman S., Ikenberry S. O., Hawes R. H., and Lehman G. A., “Alterations in Pancreatic Ductal Morphology Following Polyethylene Pancreatic Stent Therapy,” Gastrointestinal Endoscopy 44 (1996): 268–275, accessed September 21, 2025, https://www.giejournal.org/article/S0016‐5107(96)70163‐3/abstract. [DOI] [PubMed] [Google Scholar]
- 11. Bhatt H., “Post‐Endoscopic Retrograde Cholangiopancreatography Pancreatitis: An Updated Review of Current Preventive Strategies,” Clinical and Experimental Gastroenterology 14 (2021): 27–32, 10.2147/CEG.S276361. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 12. Schneider D., Knox C., and Webster G., “The Cost Implication of A Care Pathway Using Biodegradable Pancreatic Stents Versus Conventional Plastic Stents in the Prevention of Post‐ERCP Pancreatitis,” Gastrointestinal Endoscopy 99, no. 6 (2024): AB718, 10.1016/j.gie.2024.04.1715. [DOI] [Google Scholar]
- 13. Robles‐Medranda C., Cunto D., Egas‐Izquierdo M., et al., “Comparing Plastic vs Biodegradable Pancreatic Stents for the Prevention of Post‐Endoscopic Retrograde Cholangiopancreatography Pancreatitis: Preliminary Results of A Single‐Center Randomized Controlled Trial,” Gastrointestinal Endoscopy 99, no. 6 (2024): AB706–AB707, 10.1016/j.gie.2024.04.2636. [DOI] [Google Scholar]
- 14. Akshintala V. S., Kanthasamy K., Bhullar F. A., et al., “Incidence, Severity, and Mortality of Post‐ERCP Pancreatitis: An Updated Systematic Review and Meta‐Analysis of 145 Randomized Controlled Trials,” Gastrointestinal Endoscopy 98, no. 1 (2023): 1–6.e12, 10.1016/j.gie.2023.03.023. [DOI] [PubMed] [Google Scholar]
- 15. Freeman M. L., Overby C., and Qi D., “Pancreatic Stent Insertion: Consequences of Failure and Results of a Modified Technique to Maximize Success,” Gastrointestinal Endoscopy 59, no. 1 (2004): 8–14, 10.1016/S0016-5107(03)02530-6. [DOI] [PubMed] [Google Scholar]
- 16. Braithwaite J., Hibbert P., Blakely B., et al., “Health System Frameworks and Performance Indicators in Eight Countries: A Comparative International Analysis,” SAGE Open Medicine 5 (2017): 2050312116686516, 10.1177/2050312116686516. [DOI] [PMC free article] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Table S1: Table describing breakdown of cost for ERCP procedure.
Table S2: Table describing breakdown of cost for gastroscopy procedure and plastic stent removal.
Data Availability Statement
The data supporting the findings of this study are available within the article and its Supporting informations. Detailed cost breakdowns used for the cost analysis are provided in the supplementary tables. Additional data are available from the corresponding author upon reasonable request.