Introduction
Biodegradable biliopancreatic stents reduce the need for follow up visits or repeat endoscopy after endoscopic retrograde cholangiopancreatography (ERCP). Stent degradation occurs primarily by hydrolysis, and in vivo, the flow of pancreatic juice and bile across the stent is stimulated by acidic chyme within the duodenum, which is affected by use of proton pump inhibitors (PPI). We present a prospective study examining delayed stent degradation and late adverse events after ERCP.
Aims & Methods
We recruited consecutive patients who underwent ERCP with insertion of biodegradable biliopancreatic stents at our unit between June 2022 and September 2025. We performed analysis on demographic, clinical and stent-related factors. The primary outcome was the incidence of delayed stent degradation, defined by an intact stent or stent fragments seen in-situ on routine follow-up imaging after the expected degradation time. The secondary outcome was the rate of late adverse events occurring >14 days after ERCP.
Results
36 patients (58.3% female, median age 75 years) underwent ERCP with insertion of biodegradable biliopancreatic stents. Pancreatic and biliary stents were inserted in 86.1% and 13.9% of patients respectively. Pancreatic stents were 6Fr in diameter with a fast (12 days) degradation profile. Biliary stents were 10Fr in diameter with either a medium (20 days) or slow (11 weeks) degradation profile. All stents were inserted singly with a 100% technical success rate. 5 (13.9%) patients had delayed stent degradation, 4 of whom were on high dose PPI, defined as a daily dose of omeprazole 40mg and higher or its equivalent. 2 (5.6%) patients had late adverse events (pancreatitis 18 days after ERCP and cholangitis 8 months after ERCP), both of whom had delayed stent degradation.
On univariate analysis, a larger stent diameter (relative risk (RR) 21.75, 95% confidence interval (CI) 2.20-215.26, p=0.01) and use of high dose PPI (RR 37.33, 95% CI 3.08-452.04, p<0.01) were associated with delayed stent degradation. Stent length and use of low dose PPI were not associated with delayed stent degradation. On multivariable analysis, only the use of high dose PPI was significantly associated with delayed stent degradation (odds ratio 14.49, 95% CI 1.12-200.00, p=0.040).
Use of high dose PPI (RR 6.80, 95% CI 3.03-15.38, p=0.03) and delayed stent degradation (RR 11.36, 95% CI 3.85-33.33, p=0.02) were associated with late adverse events. Age, gender, stent diameter, stent length, and use of low dose PPI were not associated with late adverse events.
| | Delayed stent degradation
(n=5) | No delayed degradation
(n=31) | Relative risk
(95% CI) | p-value |
Age
≥75 years (n=19)
<75 years (n=17) |
2 (10.5%)
3 (17.6%) |
17 (89.5%)
14 (82.4%) |
0.55
(0.08-3.76) |
0.65 |
Gender
Male (n=15)
Female (n=21) |
3 (20.0%)
2 (9.5%) |
12 (80.0%)
19 (90.5%) |
2.38
(0.35-16.36) |
0.63 |
Indication of ERCP
Biliary stricture (n=18)
Choledocholithiasis (n=18) |
2 (11.1%)
3 (16.7%) |
16 (88.9%)
15 (83.3%) |
0.63
(0.09-4.28) |
1.00 |
Stent diameter
10Fr (n=5)
6Fr (n=31) |
3 (60.0%)
2 (6.5%) |
2 (40.0%)
29 (93.5%) |
21.75
(2.20-215.26) |
0.01 |
Stent length
8-10cm (n=27)
4-6cm (n=9) |
5 (18.5%)
0 (0.0%) |
22 (81.5%)
9 (100.0%) |
1.40
(1.12-1.76) |
0.30 |
Any PPI use
Yes (n=15)
No (n=21) |
4 (26.7%)
1 (4.8%) |
11 (73.3%)
20 (95.2%) |
7.27
(0.72-73.38) |
0.14 |
Low dose PPI
Yes (n=8)
No (n=28) |
0 (0.0%)
5 (17.9%) |
8 (100.0%)
23 (82.1%) |
0.74
(0.60-0.91) |
0.57 |
High dose PPI
Yes (n=7)
No (n=29) |
4 (57.1%)
1 (3.4%) |
3 (42.9%)
28 (96.6%) |
37.33
(3.08-452.04) |
<0.01 |
Conclusion
The use of high dose PPI may contribute to delayed degradation of biodegradable biliopancreatic stents. Large multi-center prospective studies are required to confirm these findings and evaluate the clinical impact of delayed stent degradation.
References
Anderloni A, Fugazza A, Maroni L, Ormando V, Maselli R, Carrara S, et al. New biliary and pancreatic biodegradable stent placement: a single-center, prospective, pilot study (with video). Gastrointest Endosc. 2020 Aug;92(2):405-411.
Pérez-Cuadrado Robles E, Lakhtakia S, Othman H, Tewethia HV, Yaacob N, Jarmin R, et al. A new biodegradable stent in bilio-pancreatic diseases: a prospective multi-center feasibility study. Rev Esp Enferm Dig. 2022 Sep;114(9):529-533.
Maieron A, Erhart L, Pramhofer P, Schöfl R, Spaun G, Steiner E, et al. Biodegradable biliopancreatic stents could help conserve health care resources during the COVID-19 pandemic: An observational multicenter study. Dig Liver Dis. 2023 Mar;55(3):310-315.
