Introduction
Endoscopic retrograde cholangiopancreatography (ERCP) stands as the primary choice for treating pancreatobiliary disorders. Among its complications, post-ERCP pancreatitis (PEP) is the most frequent, with a prevalence ranging from 4-10%, and reaching up to 15% in high-risk patients. To mitigate the hydrostatic pressure contributing to PEP in high-risk patients, the insertion of a pancreatic duct stent is considered a preventive measure. The available options for pancreatic duct stenting include plastic pancreatic stents (PPS) and biodegradable stents (BDS) placement; However, currently, there is no available data on their efficacy, nor the best setting for choosing between the two.
Aims & Methods
Our aim is to compare the effectiveness of PPS vs BDS for the preventing PEP. A single-center, prospective, randomized controlled trial (RCT) in patients with biliary tract disease requiring ERCP was conducted from January/2022 to June/2023. Subjects ≥18 years-old, with a non-manipulated pancreatic papilla and written informed consent were included in the study. Patients not requiring or failed stenting, hemodynamically unstable, pregnant or nursing subjects, at risk of fluid overload, cholangitis, sepsis, acute/flared-up chronic pancreatitis, recent biliary tract manipulation, uncontrolled coagulopathy, kidney or liver failure or comorbidities impacting the cardiac-risk assessment were excluded. During ERCP, PPS (5Fx4cm) or BDS (6Fx4cm or 6Fx6cm) were randomly selected and placed. At three-days and five-weeks post-procedure, the patients required follow-up assessment to rule-out PEP based on physical examination findings, laboratory tests (amylase, lipase, PCR, WBC and total bilirubin), abdominal ultrasound, and history of any post-ERCP hospitalization.
Results
Ninety-seven patients were enrolled (54 BDS and 43 PPS), with a median age of 53 years, 63.9% females. The main indication for ERCP was choledocholithiasis (89.7%). The median time for biliary cannulation was 5 minutes, requiring sphincterotomies in 90/97 patients. Additionally, from the 43/97 PPS cohort, biliary stents simultaneous placement was required in 13/43 (30.2%), compared to 4/54 from BDS cohort (7.4%; p=.0076). It was shown that median post-ERCP total bilirubin was significantly lower in both PPS (1.04 vs 0.96; p=.0338) and BDS cohort (1.04 vs 0.52 mg/dL; p=.0044). The same was observed for median C-reactive protein in PPS (7.03 vs 4.10 mg/dL; p=.0338) and BDS (11.2 vs 5.1 mg/dL; p=.01). Meanwhile, median post-ERCP lipase was significantly higher in both PPS (47 vs 54.8 mg/dL; p=.05) and BDS (48.5 vs 110 mg/dL; p=.0134). PEP was noticed in 8/97 (8.2%), with no significant difference in prevention when PPS and BDS were compared (14% vs 3.7%; p=.133).
Conclusion
A lower but non-significant rate of PEP prevention using BDS vs PPS was noticed. The significant reduction on total bilirubin levels, mainly in the BDS cohort, deserves further studies that must be conceived around this endpoint.
References
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Disclosure
Carlos Robles-Medranda is a key opinion leader and consultant for Pentax Medical, Steris, Medtronic, Motus, Micro-tech, G-Tech Medical Supply, CREO Medical, EndoSound, and mdconsgroup. All other authors declare no conflicts of interest.