Abstract

Pancreatic plastic stents (PPS) can reduce the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP). Prospective multicenter documentation of PEP rate after PPS placement is scarce. A new 4-Fr stent designed to be deployed over a 0.035-inch guidewire was used to assess the effectiveness of PEP prophylaxis. High-PEP-risk patients received a 4-Fr PPS for primary or secondary prophylaxis at seven centers in four countries. Patients were followed until spontaneous PPS migration, endoscopic stent removal, or for 4months, whichever came first. Main outcome was PEP rate. One hundred six (106) patients received PPS for PEP prophylaxis [61 (58%) primary, 45 (42%) secondary prophylaxis]. Median age was 54 years. Eighty-one (76%) PPS were placed using a 0.035-inch guidewire. By investigator choice 99 (93%) stents were single pigtail. Median stent length was 8cm (range 3-12cm). Technical success achieved in 100% of cases. Two patients in the primary prophylaxis group (3%, 95% CI 0.4-11%) experienced mild/moderate PEP. Seventy-eight PPS available for analysis underwent spontaneous migration after a median of 29days. There were no reports of stent-induced ductal trauma. Post-hoc analysis of migration rate by PPS length showed no statistically significant trend. Among high-risk patients in the primary prophylaxis group, observed rates of PEP are low (3%, 95% CI 0.4-11%) with the use of prophylactic 4-Fr pancreatic duct stents compatible with a 0.035-inch guidewire. This low rate is not unequivocally due to the prophylactic stent.

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