Novel Biodegradable Internal Stent as a Mitigation Strategy in High-risk Pancreaticojejunostomy: Update after 50 Cases

Purpose: Assessing the risk of postoperative pancreatic fistula (POPF) after pancreaticoduodenectomy (PD) can identify those patients at higher risk of developing this complication. In these high-risk patients, internal stents can be used as a mitigation strategy. Our preliminary results showed promising results in terms of POPF mitigation. The aim of this study is to evaluate our experience after 50 cases. Material and methods: Biodegradable internal Archimedes™ stents were routinely placed in all high-risk pancreaticojejunostomy as defined by the fistula risk score according to Callery et al. All patients receiving an Archimedes™ IBS between October 2020 and October 2022 were retrospectively reviewed and analyzed. Results: Fifty high-risk patients underwent stent placement after PD during the study period. A 2-mm Archimedes™ stent was placed in 33 (66.0%) patients, while the remaining 17 (34.0%) received a 2.6-mm stent. Overall severe complications (Clavien-Dindo 3a or more) occurred in 13 (26.0%) patients. Nine (18.0%) patients developed a POPF, graded C in 3 (6.0%) patients. Severe delayed gastric emptying, post-pancreatectomy hemorrhages, and biliary leak, occurred in 7 (14.0%), 8 (16.0%), and 0 (0.0%), patients respectively. Four (8.0%) patients died within 90 days from the procedure, one (2.0%) of these after grade C POPF. Conclusions: This larger experience supported our preliminary results, showing an encouraging low rate of POPF and other pancreas-specific complications with the use of Archimedes™ stents in high-risk patients. Comparative studies are required to confirm the results of this study.