Non-inferiority of biodegradable pancreatic stents vs plastic stents in prophylaxis of post-ERCP pancreatitis: a pilot study.

Aims Prophylactic pancreatic stenting reduces post-ERCP pancreatitis (PEP) in high-risk patients. Conventional plastic stents require follow-up imaging and often endoscopic removal, adding environmental and economic burdens. Biodegradable stents have arisen as a more sustainable alternative. This study aimed to assess the non-inferiority of biodegradable stents versus plastic stents in preventing PEP.

Methods This retrospective, single-center study compared patients receiving conventional plastic prophylactic stents (Group A) versus biodegradable prophylactic pancreatic stents (Group B) from April 2020 to July 2024. Non-inferiority margin for PEP was defined as 5%. Univariate analysis was performed using the Chi-square test or Fisher’s exact test for categorical variables, as appropriate. A multivariate logistic regression analysis was performed to identify factors associated with PEP. Statistical significance was set at p<0.05 [1] [2] [3] [4].

Results 177 patients were included, 91 in Group A (plastic) and 94 in Group B (biodegradable). No differences were found between groups in terms of gender, age or indication for ERCP (benign vs malignancy). Pre-cut sphincterotomy was more prevalent in group B (n=55, 64%) vs. group A (n=35, 38.5%), p<0.001. Both groups were comparable regarding history of previous pancreatitis, history of renal failure, wire insertion in the pancreas twice or more and presence of dilated extrahepatic ducts. 19 PEP occurred, 7 in group A (7.69%, 95%CI 1.67%-13.71%) and 12 in group B (12.77%, 95% CI 6.02% – 19.51%), the difference in the rate of PEP was 5.1% (95% CI -3.61% – 13.76%, p=0.37). Multivariate analysis found that a dilated CBD was a protective factor for PEP (OR -1.35; CI 95% 0.087-0.767, p=0.015), while precut or the type of stent used were not associated.

Conclusions In our study, the risk difference for biodegradable prophylactic pancreatic stents was indeterminate and it did not reach the non-inferiority margin when compared to conventional plastic stents. Nonetheless, these results should be interpreted carefully, given the small number of patients included, as well as the retrospective, non-randomized and single-center nature of the study design. The presence of 19 episodes of PEP only allowed to adjust for two confounding variables. Future prospective, multi-centre and larger studies could prove the non-inferiority of these biodegradable stents, especially considering that they potentially provide a more convenient approach for patients which is greener and overall more affordable to the health economy compared to plastic prophylactic pancreatic stents.

Publication History

Article published online:
27 March 2025

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