A biodegradable non-covered self-expandable stent to treat pancreatic duct strictures in chronic pancreatitis: a proof of principle

Background and Aims In chronic pancreatitis (CP), fibrotic pancreatic duct (PD) strictures pose a therapeutic challenge, because endoscopic dilatation requires multiple procedures with suboptimal results. Biodegradable self-expandable stents (BD-SESs) may serve as an alternative in this setting. Methods Patients with CP were eligible for this proof-of-principle study if at least 6 months of endoscopic dilatation with plastic stents had failed to resolve their PD stricture. The non-covered BD-SESs were expected to degrade within 3 to 6 months. Patients were followed at 3-monthly intervals for 1 year. Placement success and safety were the primary outcome parameters. Stricture resolution was assessed by ERCP after 6 months. Results BD-SESs were successfully placed in all 19 patients without adverse events. In 2 cases, stent occlusion with sludge and stones was treated by a balloon swipe. One stent disintegrated during this procedure, after which placement of the plastic stent was resumed. A hyperplastic response was observed in 2 patients but did not result in functional obstruction. Stricture resolution was accomplished in 11 patients (technical success rate 58%). Six patients required further treatment of their PD stricture, 4 endoscopically and 2 surgically. Three additional patients underwent surgery for other reasons: 2 Whipple procedures for CP-related adverse events and one tail resection for an intraductal papillary mucinous neoplasm. The remaining 10 patients did not require further PD drainage (clinical success rate 52%). Conclusions These preliminary results show that BD-SESs are safe to use and able to resolve fibrotic PD strictures in CP. These encouraging outcomes warrant further testing. In chronic pancreatitis (CP), fibrotic pancreatic duct (PD) strictures pose a therapeutic challenge, because endoscopic dilatation requires multiple procedures with suboptimal results. Biodegradable self-expandable stents (BD-SESs) may serve as an alternative in this setting. Patients with CP were eligible for this proof-of-principle study if at least 6 months of endoscopic dilatation with plastic stents had failed to resolve their PD stricture. The non-covered BD-SESs were expected to degrade within 3 to 6 months. Patients were followed at 3-monthly intervals for 1 year. Placement success and safety were the primary outcome parameters. Stricture resolution was assessed by ERCP after 6 months. BD-SESs were successfully placed in all 19 patients without adverse events. In 2 cases, stent occlusion with sludge and stones was treated by a balloon swipe. One stent disintegrated during this procedure, after which placement of the plastic stent was resumed. A hyperplastic response was observed in 2 patients but did not result in functional obstruction. Stricture resolution was accomplished in 11 patients (technical success rate 58%). Six patients required further treatment of their PD stricture, 4 endoscopically and 2 surgically. Three additional patients underwent surgery for other reasons: 2 Whipple procedures for CP-related adverse events and one tail resection for an intraductal papillary mucinous neoplasm. The remaining 10 patients did not require further PD drainage (clinical success rate 52%). These preliminary results show that BD-SESs are safe to use and able to resolve fibrotic PD strictures in CP. These encouraging outcomes warrant further testing.